Wet AMD – COMPASS Trial

Who is the sponsor?

Genentech (Roche), Inc.

Who are the patients?

Individuals with previously untreated wet macular degeneration

How long is the trial?

One year

What is the enrollment goal for the sponsor?

Forty patients

What is this study investigating?

Treatment-naïve (study eye) patients with newly diagnosed neovascular AMD will be evaluated in this study to determine if early treatment will maintain good visual acuity. Future AMD therapy may need to target high-risk individuals prior to disease conversion from dry-AMD to wet-AMD. This study plans to look at 40 patients and see if they are identified early and treated with monthly ranibizumab for one year, can all achieve a vision similar or better to their baseline vision before they developed wet AMD. If all patients are not capable of returning to their pre-AMD vision, there may be a role for earlier therapy.


Wet AMD – CATT (Comparison of AMD Treatments Trial)

Who is the sponsor?
National Institute of Health (NIH) and National Eye Institute (NEI).

Who are the patients?
Individuals with macular edema (swelling of the central part of the retina) associated with Age-Related Macular Degeneration. The participating doctor will evaluate the patient to determine his/her eligibility into the study in accordance with the Study Eligibility and Exclusion Criteria.

What is this study investigating?
This study compares the efficacy of FDA-approved ranibizumab (Lucentis) to off-label bevacizumab (Avastin), in individuals with wet macular degeneration.

How is the treatment administered?
Both drugs are administered through intravitreal injection.


Retinal Vein Occlusion – Ranibizumab for 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?
All subjects are monitored for two years.

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.


Dry AMD – 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 is the trial?
Approximately 21 months.

What is the enrollment goal for the sponsor?
Enrollment was completed in June 2011. 120 patients were enrolled into this study.

What is this study investigating?
This is a Phase 1, 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?
Participants will be randomized to receive intravitreal eye injections of study drug monthly or every other month or sham injections monthly or every other month.


Diabetic Retinopathy – Topical NSAIDs for non-central DME

Non-steroidal anti-inflammatory topical eye drop solutions will be tested in a clinical trial to determine the efficacy of the drug in preventing the progression of non-central diabetic macular edema into center-involved diabetic macular edema. The study will be conducted by the Diabetic Retinopathy Clinical Research Network and sponsored by the National Institute of Health and National Eye Institute.


Diabetic Retinopathy – Regeneron VEGF Trap-Eye for DME

Regeneron and Bayer HealthCare are studying an investigational new compound, VEGF Trap-Eye (aflibercept ophthalmic solution) in the treatment of diabetic macular edema. The experimental compound has proved effective through clinical trials in patients with wet AMD and retinal vein occlusion. Phase 3 clinical trials are underway in the United States and other countries for patients with diabetic macular edema.


Diabetic Retinopathy – REEF Trial for Diabetic Macular Edema

Who is the sponsor?

Genentech (Roche), Inc. and California Retina Consultants

Who are the patients?

Individuals with diabetic macular edema unresponsive to previous treatment.

How long is the trial?

One year

What is the enrollment goal for the sponsor?

Fifty patients

What is this study investigating?

To assess the role of ranibizumab therapy in individuals with diabetic macular edema unresponsive to previous medical treatment.


Diabetic Retinopathy – Laser and Ranbizumab or Triamcinolone for Diabetic Macular Edema

Who is the sponsor?
National Eye Institute(NEI)

Who are the patients?
Male or female eighteen years of age and older. The participating doctor will evaluate you to determine your eligibility into the study in accordance with the Study Eligibility and Exclusion Criteria.

How long is the trial?
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. Follow-up for this trial has been extended to 5 years.

When did participation agreement start at our site?
June 2007

What is the enrollment goal for the sponsor?
691 patients nationwide.

Is the enrollment still open?
Enrollment was completed in December 2008.

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 triamcinolone acetonide in combination with focal laser photocoagulation in eyes with center-involved DME.

How is the treatment administered?
Ranibizumab (Lucentis) or triamcinolone acetonide are given as an injection into the eye. In focal photocoagulation, a specialized set of ophthalmic equipment and lenses is used to focus a powerful beam of light onto the retina.


Diabetes Education and Ocular Disease Progression Study

Effect of Diabetes Education during Retinal Ophthalmology Visits on Diabetes Control

California Retina Consultants are taking part in a study that is trying to find out if educational information about diabetes and diabetic eye diseases during an examination of the retina can help patients with diabetes take better care of their diabetes. In this two-year study, some patients will receive additional information about diabetes and diabetic eye diseases and the other half will receive the same information the eye doctor would ordinarily give patients during their regular eye exam.

The study is being conducted by the Diabetic Retinopathy Clinical Research Network (DRCRNet), and includes over 100 eye centers in the United States that specialize in the care of patients with diabetic retinopathy. The National Eye Institute and the National Institute of Diabetes and Digestive and Kidney Diseases are providing funding for this study.