RESEARCH NEWS
Some new clinical trails that we will soon be participating in or that have recently started, involve new treatments for a variety of retinal diseases. These includes studies for Vitreomacular traction (VMT), dry AMD, wet AMD , and CRVO.
Vitreomacular traction (VMT)
The Thrombogenics Clinical Trial will involve patients with focal vitreomacular
traction and 20/25 or worse vision. The goal will be to evaluate the safety and efficacy of an experimental drug,
microplasmin, when injected into the vitreous in patients with vitreomacular traction
Vitreomacular traction (VMT) is an eye condition in which the vitreous, the jelly-like substance in the center of the eye, pulls away from the retina (the light sensitive part of the eye) and can cause vision problems and other complications. Typically, early stages of vitreomacular traction are not treated and are observed for progression as some cases of VMT may resolve without treatment. In patients that develop significant visual problems, the only treatment available is a specific type of surgery called a vitrectomy to loosen the vitreous from the retina. This relieves the areas with traction and allows the retina to return to a more normal anatomy and function. Microplasmin is a protein that has been shown in a small number of patients to safely induce nonsurgical separation of the vitreous from the retina foregoing the need for invasive surgery. Participants in the Thrombogenics study, will receive a single injection of a small dose of microplasmin (125µg) or placebo vehicle (contains same liquid but without microplasmin). There is a 75% chance that the participant will receive microplasmin and a 25% chance they will receive placebo. 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. This study will determine if microplasmin can help relieve the traction or tension between the vitreous and retina and forego the need for invasive surgery.
Wet(neovascular) AMD
We will be taking part in the Genentech sponsored trial HARBOR. The HARBOR Trial supported by Genentech, Inc. (South San Francisco, CA),
is a two year study comparing the safety and efficacy of multiple injections into the eye of different doses of ranibizumab in patients
with wet age-related macular degeneration (2.0 mg versus 0.5 mg). Participants will have a 50% chance of receiving either the 2.0 mg dose
or 0.5 mg dose. 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. The purpose of this study is to determine if higher doses of ranibizumab result in better visual outcomes over time and
if the best possible visual outcomes can be achieved with fewer injections. To minimize bias in the study results, the physician and patient
\will not know the dose a participant receives. However, this information can be made available in the event of a life-threatening emergency.
Participants will return monthly for an office visit comprising of a complete eye examination, optical coherence tomography scans and
comprehensive vision testing. Photographic examination of the inside of the eye including fluorescein angiography will be performed every
three months. Small samples of blood may also be collected from consenting participants to analyze the level of study drug in your blood
and to look at genes that are known to be associated with macular degeneration. All genetic testing results are confidential, are for
research use only and will not be available to participants.
We will be enrolling eligible patients with previously untreated, newly diagnosed wet-AMD with the goal of comparing the outcome and success of a different dose of ranibizumab (2.0 mg) to the commercially available 0.5 mg dose of ranibizumab in patients with wet-AMD.
Dry AMD
There is still currently not an approved treatment available for patients with dry macular degeneration. In July of 07 we began enrolling
eligible patients with dry AMD in the Othera Omega trial in our Oxnard office. Enrollment for this trail is currently closed and is in
long-term follow-up. This trail used the compound OT-551 administered in an eye drop to evaluate it for treatment in dry AMD.
We will be starting a new trail for dry AMD call Complement Factor D. Scheduled to begin enrollment this fall, the research trial is
designed to investigate a new experimental compound in patients with geographic atrophy associated with dry macular degeneration
(Genentech Inc., South San Francisco, CA). Participants will receive a single injection of the experimental compound at different dose
levels. 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.
Eligibility for this trial will be patients with geographic atrophy due to dry age-related macular degeneration with a goal of testing the
safety of a new experimental drug.
Central Retinal Vein Occlusion (CRVO)
Vascular endothelial growth factor (VEGF) is a protein produced by the body that is known to cause the growth of new abnormal blood vessels
and promote excessive fluid leakage. Increased levels of VEGF are present in eye of patients with conditions such as wet macular degeneration,
diabetic retinopathy and retinal vein occlusions. Encouraging results from anti-vegf studies in patients with wet macular degeneration and
diabetic macular edema provide rationale for the use of anti-vegf therapy in patients with retinal vein occlusions.
Two research trials will be opening later this year to investigate the use of drugs designed to bind and neutralize VEGF in the eye.
In a study supported by Regeneron Pharmaceuticals, Inc., patients with macular edema (swelling in the center of the retina) due to a central retinal vein occlusion are eligible for treatment with an experimental drug, Anti-VEGF Trap-Eye. This is a two year 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. Starting at month 6 all participants will be eligible for injection with Anti-VEGF Trap-Eye. 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.
In a separate research trial designed by California Retina Research Foundation Medical Director, Dante J. Pieramici, M.D. and colleagues, participants will receive eye injections with different doses of ranibizumab to treat macular edema due to a central retinal vein occlusion. Participants will receive either 0.5 mg dose or 2.0 mg dose of ranibizumab 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.
Comprehensive eye examinations, vision testing, photographs of the retina and optical coherence tomography scans will be performed monthly to monitor each participants' response to treatment.
If you would like more details please contact one of our study coordinators at (805) 963-1648 . We give thanks to all those individuals, patients, employees, colleagues, and donors who continue to support our research endeavors.