Clinical Studies
One mission of our practice is to provide patients the opportunity to participate locally in national clinical trials of new treatments for severe retinal diseases. The doctors of California Retina Consultants, have been recognized for their involvement in numerous national and international clinical trials of novel treatments for complications of diabetic retinopathy, macular degeneration, retinal detachments, and ocular injuries.
In conjunction with The California Retina Research Foundation, The Neuroscience Research Institute of The University of California at Santa Barbara, and the National Eye Institute, the doctors continue to explore the causes and cures for serious retinal diseases.
Participation in a clinical trial is completely voluntary. Eligibility for enrollment into a particular trial is determined through a screening process that varies from study to study. Because of the specific nature of your disease, you may not be eligible for participation. If you decide not to participate or are deemed ineligible, the doctors will continue to care for your eyes and provide you with the highest standard of care available.
Please feel free to call our study coordinator with any question about the studies. 805 963-1648
List Of Studies
Select a category of studies to view:
Bausch & Lomb / CDS STUDY
Who is the sponsor?
Bausch & Lomb /Control Delivery Systems( Now pSividia)
Who are the patients?
Males and non-pregnant females at least eighteen years of age with diabetic macular edema.
How long are the eligible patients enrollment?
Four years.
When did participation agreement start at our site?
August 20, 2001
What is the enrollment goal for the sponsor?
One hundred and eighty nationwide
Is the enrollment still open?
No. This study is now closed
What is this study investigating?
This is a multicenter, randomized, masked, controlled study to evaluate the safety and efficacy of RetisertTM, an intravitreal fluocinolone acetonide implant, in the treatment of patients with diabetic macular edema (DME). Patients who qualify for enrollment are randomly assigned one of the following surgeries to one eye: 1.) RetisertTM implant alone. 2.) RetisertTM implant and a vitrectomy. 3.) Placebo implant and a vitrectomy
How is the treatment administered?
Surgical implant.
MICROPULSE
Who is the sponsor?
California Retina Research Foundation
Who are the patients?
Participants with macular edema (swelling of the central part of the retina) associated with backround diabetic retinopathy(BDR) and proliferative diabetic retinopathy(PDR) who are 18 years of age or older and are willing to provide consent may be eligible for the Micropulse Study. The participating doctor will evaluate the patient to determine his/her eligibility into the study in accordance with the Study Eligibility and Exclusion Criteria.
How long are the eligible patients enrollment?
18 Months
When did participation agreement start at our site?
November of 2002
What is the enrollment goal for the sponsor?
15 patient
Is the enrollment still open?
No. This study is now closed
What is this study investigating?
To determine if the use of short(100 microsecond) bursts of energy will elicit the beneficial effects of photocoagulation and limit the damage to photoreceptors and other portions of the retina which are frequently damaged by conventional laser.
How is the treatment administered?
Micropulse laser.
ATG003
Who is the sponsor?
Comentis
Who are the patients?
Patients who receive frequent anti-vegf injections for recurrent macular edema due to neovascular AMD and have shown past resolution of leakage with anit-vegf treatment.
How long are the eligible patients enrollment?
One year follow up with monthly ophthalmic examination
When did participation agreement start at our site?
What is the enrollment goal for the sponsor?
15 patients (soon to be closed to enrollment)
Is the enrollment still open?
Yes, enrollment soon to be closed
What is this study investigating?
To determine if the combination of ATG003 (an eye drop) administered twice daily by the patient with LucentisTM or AvastinTM can reduce the number of injections required and reduce the need for repeat injections.
How is the treatment administered?
Eye drop
SCORE The Standard Care vs. COrticosteroid for REtinal Vein Occlusion Study
Who is the sponsor?
Emmes Coporation and National Eye Institute(NEI)
Who are the patients?
Participants with macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO) who are 18 years of age or older and are willing to provide consent may be eligible for the SCORE Study. The paticipating doctor will evaluate you to determine your eligibility into the study in accordance with the Study Eligibility and Exclusion Criteria.
How long are the eligible patients enrollment?
3 years
When did participation agreement start at our site?
August 2004
What is the enrollment goal for the sponsor?
972 participants: 486 CRVO participants and 486 BRVO participants.
Is the enrollment still open?
No
What is this study investigating?
This is a multi-center, randomized Phase III trial study designed to assess the efficacy and safety of standard care versus triamcinolone acetonide injection(s) for the treatment of macular edema associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO) with the follow objectives: Compare visual acuity outcome among 3 groups of participants: Those who are randomly assigned to receive standard care. Those randomly assigned to receive one of two doses of intravitreal injection(s) of triamcinolone acetonide for treatment of macular edema associated with central retinal vein occlusion (CRVO). Those randomly assigned to receive one of two doses of intravitreal injection(s) of triamcinolone acetonide for treatment of macular edema associated with branch retinal vein occlusion (BRVO).
How is the treatment administered?
Laser photcoagulation or Intravitreal injection
EyeTech/Macugen
Who is the sponsor?
EyeTech Pharmaceuticals(Now OSI Pharmaceuticals)
Who are the patients?
Male or female over the age of fifty years with AMD The paticipating doctor will evaluate you to determine your eligibility into the study in accordance with the Study Eligibility and Exclusion Criteria.
How long are the eligible patients enrollment?
One year. Patients have a random chance of continuing for a second year.
When did participation agreement start at our site?
April 4, 2001
What is the enrollment goal for the sponsor?
Five hundred and forty nationwide.
Is the enrollment still open?
No. This study is now closed
What is this study investigating?
Abnornal VEGF(vascular endothelial growth factor) production may be contributing to the pathology of neovascular(abnormal new vessel growth) AMD. MacugenTM is a PEGylated anti-VEGF aptamer. The aim of using an anti-VEGF aptamer for treating neovascular AMD is to neutralize VEGF in the eye by binding to VEGF and preventing it from binding into its receptor, there by mitigating the abnormal growth of blood vessels.
How is the treatment administered?
Intravitreal injections.
Genentech (Seagul) - Lucentis for AMD
Who is the sponsor?
Genentech
Who are the patients?
Male or female over the age of fifty years with AMD The paticipating doctor will evaluate you to determine your eligibility into the study in accordance with the Study Eligibility and Exclusion Criteria.
How long are the eligible patients enrollment?
Assessments for treatment will be done monthly for a period of 12 months.
When did participation agreement start at our site?
August 2007
What is the enrollment goal for the sponsor?
Twenty patients.
Is the enrollment still open?
No. This study is now closed
What is this study investigating?
This is an open-label study of treatment-naïve patients treated with on-label ranibizumab for neovascular age-related macular degeneration (AMD) with the following objective: To determine VEGF and HTRA1 SNP genotypes of patients gaining ?0 letters of visual acuity in response to ranibizumab treatment over a 4 month period. To determine VEGF and HTRA1 SNP genotypes of patients with worse3ning vision (gaining <0 letters) while receiving ranibizumab treatment over 4 and 12 month periods, as well as patients gaining ?0 letters over 6 and 12 month time periods. Lastly, to correlate changes in retinal thickness in patients receiving Lucentis with their genotypes.
How is the treatment administered?
Intravitreal Injections of LucentisTM(ranibizumab)
Genentech (Marina)
Who is the sponsor?
Genentech
Who are the patients?
Male or female over the age of fifty years with AMD The paticipating doctor will evaluate you to determine your eligibility into the study in accordance with the Study Eligibility and Exclusion Criteria.
How long are the eligible patients enrollment?
Assessments will be done monthly for a period of 24 months
When did participation agreement start at our site?
July 17, 2003
What is the enrollment goal for the sponsor?
Seven hundred and twenty patients nationwide.
Is the enrollment still open?
No. This study is now closed
What is this study investigating?
This is a Phase III, multicenter, randomized, double-masked, placo-controlled study. Designed to evaluate the safety and efficacy of LucentisTM (ranibizumab, rhuFAb V2) to significantly reduce the risk of vision loss. Patients will be assigned one of the following treatment arms: 1. Sham injection(placebo) 2. LucentisTM Dose A 3. LucentisTM Dose B This study will evaluate patients that have active, minimally classic or occult type wet AMD and compare those receiving LucentisTM (ranibizumab, rhuFAb V2) to those receiving the sham(placbo) treatment.
How is the treatment administered?
Intravitreal injections.
Genentech (Anchor)
Who is the sponsor?
Genentech
Who are the patients?
Male or female over the age of fifty years with AMD The paticipating doctor will evaluate you to determine your eligibility into the study in accordance with the Study Eligibility and Exclusion Criteria.
How long are the eligible patients enrollment?
Assessments will be done monthly for a period of 24 months
When did participation agreement start at our site?
July 17, 2003
What is the enrollment goal for the sponsor?
Four hundred and twenty-six patients nation wide.
Is the enrollment still open?
No. This study is now closed
What is this study investigating?
This is a Phase III, multicenter, randomized, double-masked, placo-controlled study. Designed to evaluate the safety and efficacy of LucentisTM (ranibizumab, rhuFAb V2) to significantly reduce the risk of vision loss. Patients will be assigned one of the following treatments: 1. PDT + Sham injection(placebo) 2. Sham PDT + LucentisTM Dose A 3. Sham PDT + LucentisTM Dose B This study will evaluate patients that have active, predominantly classic type wet AMD and compare those receiving LucentisTM (ranibizumab, rhuFAb V2) to those receiving just the PDT( VerteporfinTM Photodynamic laser Therapy) treatment.
How is the treatment administered?
Intravitreal injections.
Genentech (Horizon)
Who is the sponsor?
Genentech
Who are the patients?
Patients who have completed participation in certain other LucentisTM clinical studies and meet the eligibility criteria
How long are the eligible patients enrollment?
3 years
When did participation agreement start at our site?
2005
What is the enrollment goal for the sponsor?
Not stated
Is the enrollment still open?
No. This study is now closed
What is this study investigating?
Phase III open-label extension study, which allows eligible patients who have completed participation in certain other LucentisTM clinical studies to continue to receive the investigational drug.
How is the treatment administered?
Intravitreal injections.
SAILOR(Safety Assessment of Intravitreal Lucentis fOR AMD) Study
Who is the sponsor?
Genentech, Inc.
Who are the patients?
Male or female over the age of fifty years with AMD The paticipating doctor will evaluate you to determine your eligibility into the study in accordance with the Study Eligibility and Exclusion Criteria.
How long are the eligible patients enrollment?
One year.
When did participation agreement start at our site?
Dec 2005
What is the enrollment goal for the sponsor?
Is the enrollment still open?
No. This study is closed.
What is this study investigating?
This is a Phase IIIb clinical study of LucentisTM (ranibizumab, rhuFAb V2) for patients with all subtypes of new or recurrent active subfoveal wet AMD. The study is designed to evaluate the safety of two different doses (0.3 mg and 0.5 mg) of Lucentis administered once a month for three months and thereafter as needed based on re-treatment criteria.
How is the treatment administered?
Intravitreal injections
CDME1 Clinical Trial
Who is the sponsor?
National Eye Institute(NEI)
Who are the patients?
Patients 18 years of age and older with type 1 or type 2 diabetes and macular edema. The paticipating doctor will evaluate you to determine your eligibility into the study in accordance with the Study Eligibility and Exclusion Criteria.
How long are the eligible patients enrollment?
All patients will return for follow-up visits at 3, 6, and 12 months. After the first year, patients will be followed every 6 months until either the patient returns for a 3-year visit or the last enrolled patient returns for the 1-year visit.
When did participation agreement start at our site?
One hundred nation wide.
What is the enrollment goal for the sponsor?
One hundred nationwide.
Is the enrollment still open?
No. This study is now closed
What is this study investigating?
This study will compare two types of laser treatments for diabetic macular edema, a common condition in patients with diabetes. This study will also examine whether celecoxib (Celebrex® (Registered Trademark)), an anti-arthritis drug that reduces inflammation and swelling, can reduce inflammation and swelling of the retina.
How is the treatment administered?
Laser therapy and Drug therapy(celecoxib).
VIO (VisudyneTM In Occult) study
Who is the sponsor?
QLT and Novartis Opthalmics
Who are the patients?
Male or female over the age of fifty years with AMD The paticipating doctor will evaluate you to determine your eligibility into the study in accordance with the Study Eligibility and Exclusion Criteria.
How long are the eligible patients enrollment?
Assessments will be done every three months for a period of 24 months
When did participation agreement start at our site?
Nov 11, 2002
What is the enrollment goal for the sponsor?
Three hundred and sixty patients nation wide.
Is the enrollment still open?
No. This study is now closed
What is this study investigating?
This is a Phase III, multicenter, randomized, double-masked, placo-controlled study to demonstrate that VisudyneTM therapy in patients with "occult type" wet AMD, significantly reduce the risk of vision loss compared with placebo (sham treatment).
How is the treatment administered?
IV injection of VisudyneTM with PDT treatment or placebo
SurModics Study
Who is the sponsor?
SurModics
Who are the patients?
Male or female eighteen years of age and older who have macular edema associated with diabetic retinopathy, not responding to laser treatment after at least 90 days.
How long are the eligible patients enrollment?
Three years
When did participation agreement start at our site?
What is the enrollment goal for the sponsor?
30 patients
Is the enrollment still open?
No. This study is now closed
What is this study investigating?
This is a phase 1, multicenter, randomized, double -masked study with the following objectives: * * To evaluate the safety, tolerability and duration of effect of a helical intravitreal triamcinolone implant for the treatment of diabetic macular edema. * The implant is designed to replace multiple injections(the current method for intravitreous drug delivery) with a single implant providing long-term, controlled drug release which could represent a significant advance in therapeutic treatment, including improved patient compliance, reduced side effects and greater efficacy.
How is the treatment administered?
Study patients are randomly assigned to one of two formulations of the helical intravitreal triacinolone implant which is surgically implanted.
AMD STUDY - AvastinTM and PDT for AMD
Who is the sponsor?
California Retina Research Foundation
Who are the patients?
Male or female patients over the age of fifty years with AMD The participating doctor will evaluate the patient to determine his/her eligibility into the study in accordance with the Study Eligibility and Exclusion Criteria.
How long are the eligible patients enrollment?
Assessments for treatment will be made every 4-6 weeks for a period of 12 months. Then safety visits will follow between months 12 through 24.
When did participation agreement start at our site?
June 2006
What is the enrollment goal for the sponsor?
Twenty-five patients
Is the enrollment still open?
No . Is still ongoing at this time
What is this study investigating?
This is a Phase II randomized study using Intravitreal AvastinTM(bevacizumab) in combination with VisudyneTM (PDT) for the treatment of neovascular age-related macular degeneration (AMD) with the following objective: To evaluate safety, visual acuity (VA) outcomes, persistence of choroidal neovascular (CNV) leakage, and the number of treatments of combination intravitreal bevacizumab and verteporfin PDT (standard or reduced fluence) in patients with subfoveal CNV due to age-related macular degeneration (AMD).
How is the treatment administered?
Intravitreal Injections of AvastinTM. For the PDT treatment, Visudyne TMwill be administered with an IV injection then a cold type laser will follow.
CRVO LucentisTM Study
Who is the sponsor?
California Retina Research Foundation
Who are the patients?
Male or female patients over the age of eighteen years with CRVO The participating doctor will evaluate the patient to determine his/her eligibility into the study in accordance with the Study Eligibility and Exclusion Criteria.
How long are the eligible patients enrollment?
Assessments will be made every month for a span of 24 months.
When did participation agreement start at our site?
January 2006
What is the enrollment goal for the sponsor?
Twenty patients
Is the enrollment still open?
No. Is still ongoing at this time
What is this study investigating?
This is a Phase I study using Intravitreal LucentisTM (ranibizumab) in the treatment of macular edema associated with perfused central retinal vein occlusive disease (CRVO).
How is the treatment administered?
By intravitreal Injection.
Horizon Cohort 2
Who is the sponsor?
Genentech
Who are the patients?
Subjects with Choroidal Neovascularization (CNV) Secondary to Macular Edema Secondary to Retinal Vein Occlusion (RVO) Who Have Completed a Genentech-Sponsored Ranibizumab Study.
How long are the eligible patients enrollment?
Patients are followed-up with on a quarterly basis, or more often as needed, for 2 years
When did participation agreement start at our site?
Summer 2008
What is the enrollment goal for the sponsor?
Is the enrollment still open?
No. Is still ongoing at this time
What is this study investigating?
This is an Open-Label, Multicenter Extension Study. It will investigate and evaluate the long-term safety, tolerability, and efficacy of multiple intravitreal injections of open-label ranibizumab administered to subjects with macular edema secondary to RVO (Cohort 2) who completed a Genentech-sponsored trial.
How is the treatment administered?
Intravitreal Ranibizumad at the discretion of the physician.
Genentech BRAVO - LucentisTM for BRVO
Who is the sponsor?
Genentech
Who are the patients?
Male or female patients over the age of eighteen with BRVO or HRVO The participating doctor will evaluate the patient to determine his/her eligibility into the study in accordance with the Study Eligibility and Exclusion Criteria.
How long are the eligible patients enrollment?
Assessments will be made every month for one year with the safety assessments during the second year.
When did participation agreement start at our site?
July 2007
What is the enrollment goal for the sponsor?
300 patients between 70 sites
Is the enrollment still open?
No. Is still ongoing at this time
What is this study investigating?
This is a Phase III, multi-center, randomized(LucentisTM), sham injection-controlled study of the efficacy and safety of ranibizumab injection compared with sham in subjects with macular edema secondary to branch retinal vein occlusion (BRVO) with the following objectives: To evaluate the efficacy of intravitreal injections of ranibizumab administered monthly for six months in the improvement of visual acuity as measured by the mean change in best corrected visual acuity (BCVA), visual acuity outcomes other than BCVA, anatomic changes, and patient reported visual function outcomes at 6 months compared to baseline To evaluate the safety and tolerability of intravitreal injections of ranibizumab administered monthly for 6 months, followed by a 6 month observation period with protocol-specified retreatment criteria. To evaluate the pharmacokinetics of ranibizumab in subjects with BRVO
How is the treatment administered?
Intravitreal Injection, or sham injection with laser treatment
DRCRN (Diabetic Retinaopathy Clinical Research Network) Intravitreal Ranibizumab or Triamcinolone Acetonide in Combination with Laser Photocoagulation for Diabetic Macular Edema- Protocol I
Who is the sponsor?
National Eye Institute(NEI)
Who are the patients?
Male or female eighteen years of age and older. The paticipating doctor will evaluate you to determine your eligibility into the study in accordance with the Study Eligibility and Exclusion Criteria.
How long are the eligible patients enrollment?
Visits every 4 weeks for up to 3 years as long as injections are being given. After the first year visits become once every 4 months after injections stop for the full 3 years.
When did participation agreement start at our site?
June 2007
What is the enrollment goal for the sponsor?
Seven hundred patients nationwide
Is the enrollment still open?
No. Is still ongoing at this time
What is this study investigating?
This is a multicenter, randomized study with the following objectives: Evaluate the safety and efficacy of (1)intravitreal ant-VEGF treatment in combination with focal laser photocoagulation, (2) intravitreal anti-VEGF treatment alone, and (3) intravitreal corticosteroids in combination with focal laser photocoagulation in eyes with center-involved DME.
How is the treatment administered?
Intravitreal Injections for the Ranibizumab, and Corticosteroid Focal Photocoagulation Laser.
RAP Trial - Lucentis and PDT for AMD
Who is the sponsor?
Novartis Pharmaceuticals
Who are the patients?
Male or female patients over the age of fifty with AMD The participating doctor will evaluate the patient to determine his/her eligibility into the study in accordance with the Study Inclusion and Exclusion Criteria.
How long are the eligible patients enrollment?
Assessments for treatment will be made every month for a period of 12 months. Then safety visits will follow between months 12 through 24.
When did participation agreement start at our site?
June 2007
What is the enrollment goal for the sponsor?
Thirty patients
Is the enrollment still open?
No. Is still ongoing at this time
What is this study investigating?
This is a pilot randomized study using Intravitreal LucentisTM (ranibizumab) either alone or in combination with VisudyneTM (PDT) for the treatment of neovascular age-related macular degeneration (AMD) with the following objective: To evaluate safety, visual acuity (VA) outcomes, persistence of choroidal neovascular (CNV) leakage, and the number of treatments of combination intravitreal ranibizumab and verteporfin PDT (reduced fluence) versus treatment with ranibizumab alone in patients with subfoveal CNV due to age-related macular degeneration (AMD).
How is the treatment administered?
Intravitreal injections for the LucentisTM For the PDT treatment, VisudyneTM will be administered with an IV injection then a cold type laser will follow.
Data Collection of the PASCAL (Pattern Scan Laser) Photocoagulator for the Treatment of Clinically Significant Macular Edema. PASCAL 1
Who is the sponsor?
Optimedica
Who are the patients?
Patients with non-proliferative diabetic retinopathy who have clinically significant macular edema
How long are the eligible patients enrollment?
One year follow up.
When did participation agreement start at our site?
Summer 2008
What is the enrollment goal for the sponsor?
5 patients
Is the enrollment still open?
No. Enrollment closed. Follow up only
What is this study investigating?
To collect and evaluate data for the use of the PASCAL laser for the treatment of clinically significant macular edema in patients with non-proliferative diabetic retinopathy
How is the treatment administered?
Focal laser photocoagulation is applied according to guidelines set forth in the Early Treatment of Diabetic Retinopathy Study
Othera - Drops for Dry AMD
Who is the sponsor?
Othera Pharmaceuticals
Who are the patients?
Male or female patients over the age of fifty-five with Dry AMD The participating doctor will evaluate the patient to determine his/her eligibility into the study in accordance with the Study Inclusion and Exclusion Criteria.
How long are the eligible patients enrollment?
Assessments for treatment will be made every 3 months for a period of 24 months.
When did participation agreement start at our site?
July 2007
What is the enrollment goal for the sponsor?
Ten-Twenty patients
Is the enrollment still open?
No. Is still ongoing at this time
What is this study investigating?
This is a Phase II randomized, double-masked, does ranging, multi-center study comparing OT-551 with vehicle placebo for the treatment of geographic atrophy (GA) progression in subjects with GA associated with age-related macular degeneration (AMD) with the following objectives: To determine if treatment with OT-551 reduces the risk of vision loss and areas of GA progression. To asses the safety profiel of OT-551 across treatments.
How is the treatment administered?
Assigned study drug is administered as an eye drop to be used four times daily with an application of two drops each time in the study eye only.
DRCRN (Diabetic Retinaopathy Clinical Research Network) Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy - Protocol J
Who is the sponsor?
National Eye Institute(NEI)
Who are the patients?
Male or female eighteen years of age and older. The paticipating doctor will evaluate you to determine your eligibility into the study in accordance with the Study Eligibility and Exclusion Criteria.
How long are the eligible patients enrollment?
Visits will occur at initial visit, 1 week, 4 weeks, 14 weeks, 34 weeks and the final visit at 56 weeks
When did participation agreement start at our site?
June 2007
What is the enrollment goal for the sponsor?
381 patients
Is the enrollment still open?
Yes
What is this study investigating?
This is a prospective, multi-center, randomized study with the following objective: Evaluate whether intravitreal injection of an anti-VEGF drug or an intravitreal injection of a corticosteroid can reduce the risk of visual acuity impairment that can occur following PRP and increase the chances of at least short-term visual acuity improvement in eyes with evidence of center-involved macular edema that are undergoing PRP for PDR.
How is the treatment administered?
Intravitreal Injections for the Ranibizumab, and Corticosteroid Focal Photocoagulation Laser and Panretinal Photocoagulation Laser
CATT (Comparison of AMD Treatments Trial)
Who is the sponsor?
National Institutes of Health(NIH) and National Eye Institute(NEI)
Who are the patients?
Participants with macular edema (swelling of the central part of the retina) associated with AMD. The participating doctor will evaluate the patient to determine his/her eligibility into the study in accordance with the Study Eligibility and Exclusion Criteria.
How long are the eligible patients enrollment?
When did participation agreement start at our site?
What is the enrollment goal for the sponsor?
10-20 patients from our site
Is the enrollment still open?
Yes
What is this study investigating?
This study is determining which drug, between Avastin TMand LucentisTM, is the better treatment for AMD as a monotherapy.
How is the treatment administered?
Both drugs are administered through intravitreal injection
Thrombogenics(TG-MV-007)
Who is the sponsor?
Thrombogenics
Who are the patients?
Participants with focal vitreomacular traction . The participating doctor will evaluate the patient to determine his/her eligibility into the study in accordance with the Study Eligibility and Exclusion Criteria.
How long are the eligible patients enrollment?
All participants will be monitored monthly for 6 months and will undergo a complete eye examination, ultrasound testing, and optical coherence tomography scans at each visit
When did participation agreement start at our site?
June 2009
What is the enrollment goal for the sponsor?
5 - 10 participants
Is the enrollment still open?
Yes
What is this study investigating?
To evaluate the safety and efficacy of intravitreal microplasmin 125µg dose to determine if microplasmin can help relieve the traction or tension between the vitreous and retina and forego the need for invasive surgery.
How is the treatment administered?
A single Intravitreal injection of a small dose of microplasmin (125µg) or placebo vehicle (contains same liquid but without microplasmin).
Genentech CRVO
Who is the sponsor?
California Retina Research Foundation
Who are the patients?
Male or female 18 Years and older with center-involved macular edema secondary to CRVO
How long are the eligible patients enrollment?
One year
When did participation agreement start at our site?
Recruiting will start soon.
What is the enrollment goal for the sponsor?
Not determined at this time
Is the enrollment still open?
Soon to be Activated
What is this study investigating?
This study will determine the Efficacy, Safety, and Tolerability of intravitreal injections in participants with macular edema secondary to Central Retinal Vein Occlusion. Either a 0.5 mg dose or a 2.0 mg dose of ranibizumab will be injected on an as needed basis, after an initial three injections up to one year. This study will determine if ranibizumab is effective in the treatment of macular edema and if the 2.0 mg dose of ranibizumab is more effective than the 0.5mg dose
How is the treatment administered?
Intravitreal injections
HIGH DOSE LUCENTISTM FOR RVO
Who is the sponsor?
Genentech
Who are the patients?
Patients with macular edema secondary to CRVO(Central Retinal Vein Occlusion) or BRVO(Branch Retinal Vein Occlusion)
How long are the eligible patients enrollment?
One year follow up. Change in mean visual acuity and central retinal thickness at month 12 compared to baseline.
When did participation agreement start at our site?
What is the enrollment goal for the sponsor?
10 CRVO and 10 BRVO patients
Is the enrollment still open?
What is this study investigating?
There are two arms to this study. One arm follows patients with CRVO, the other arm follow patient with BRVO. In the CRVO arm of the study, patients will receive monthly injections of LucentisTM(ranibizumab) for the first 2 months (3 injections), then will be treated on a PRN(as needed) treatment regimen based on persistent or recurrent macular edema. In the BRVO arm, patients will receive a combination of Focal Laser and an intravitreal injection of ranibizumab 2.0mg at baseline, followed by repeat ranibizumab injection at month 1 and 2 intervals. Patients will be evaluated for retreatment for ranibizumab injection on monthly basis based on persistent or recurrent edema. Additional laser treatment may be administered per physician discretion.
How is the treatment administered?
For the CRVO arm of the study- intravitreal injection. In the BRVO arm of the study- Focal Laser and an intravitreal injection
Complement Factor D
Who is the sponsor?
Genentech Inc
Who are the patients?
Male or female 55 years of age and older with geographic atrophy due to dry age-related macular degeneration. The participating doctor will evaluate you to determine your eligibility into the study in accordance with the Study Eligibility and Exclusion Criteria.
How long are the eligible patients enrollment?
Undetermined at this time
When did participation agreement start at our site?
Enrollment to start this fall
What is the enrollment goal for the sponsor?
Undetermined at this time
Is the enrollment still open?
Soon to be Activated
What is this study investigating?
This is a Phase1, multi-center, short-term study to test the safety of a new experimental drug in patients with geographic atrophy. This study will explore the effects of the drug in the eye and in the body, if any. Participants will undergo complete ophthalmic evaluation and undergo blood and urine analysis. Results from this short-term study will be used to support a larger long-term, multi-center clinical trial to test the effectiveness of the compound.
How is the treatment administered?
Single Intravitreal injection
Harbor
Who is the sponsor?
Genentech, Inc.
Who are the patients?
Male or female patients fifty years of age and older with previously untreated, newly diagnosed wet-AMD. The participating doctor will evaluate you to determine your eligibility into the study in accordance with the Study Eligibility and Exclusion Criteria
How long are the eligible patients enrollment?
Two years. Treatment will be administered on: (1) a monthly basis for two years or (2) on an as needed basis, after an initial three doses for two years.
When did participation agreement start at our site?
Recruiting will start soon(Oct/Nov 09)
What is the enrollment goal for the sponsor?
1100 Nationwide
Is the enrollment still open?
Soon to be activated(Oct/Nov 09)
What is this study investigating?
This is a Phase III, Double-Masked, Multicenter, Randomized, Active Treatment-Controlled Study with the following objective: To compare the outcome and success of a different dose of LucentisTM(ranibizumab) (2.0 mg) to the commercially available 0.5 mg dose of ranibizumab in patients with wet-AMD. The study goal is to determine if the higher doses can result in better visual outcomes over time and if the best possible visual outcomes can be achieved with fewer injections
How is the treatment administered?
Intravitreal injections of ranibizumab
Data Collection of the PASCAL (Pattern Scan Laser) Photocoagulator for the Treatment of Clinically Significant Macular Edema. PASCAL 2
Who is the sponsor?
Optimedica
Who are the patients?
Information pending
How long are the eligible patients enrollment?
Information pending
When did participation agreement start at our site?
Information pending
What is the enrollment goal for the sponsor?
Information pending
Is the enrollment still open?
Soon to be activated
What is this study investigating?
Information pending
How is the treatment administered?
Laser photocoagulation
Regeneron CRVO
Who is the sponsor?
Regeneron Pharmaceuticals
Who are the patients?
Male or female 18 Years and older with center-involved macular edema secondary to CRVO
How long are the eligible patients enrollment?
Two years study, in which participants have a 60% chance of receiving an injection with Anti-VEGF Trap-Eye and 40% chance of receiving a sham injection monthly for 6 months
When did participation agreement start at our site?
Recruiting for our sight will be soon.
What is the enrollment goal for the sponsor?
165 patients nationwide
Is the enrollment still open?
Soon to be Activated
What is this study investigating?
This is a Randomized, Double Masked, Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor Trap-Eye in Subjects With Macular Edema Secondary to Central Retinal Vein Occlusion. This study will help determine if Anti-VEGF Trap-Eye is effective in reducing the amount of macular edema present in eyes with a central retinal vein occlusion.
How is the treatment administered?
Intravitreal injection