We are dedicated to providing our patients with the most up-to-date treatment options. Our physicians actively seek out new options in treating retinal diseases by participating in cutting-edge clinical research trials. SCRC has enrolled hundreds of patients in studies that have helped shape the course and treatment plan for multiple retinal diseases, such as age-related macular degeneration, diabetic macular edema, retinal vein occlusion and proliferative diabetic retinopathy.
The following research trials are currently offered at South Coast Retina Center:
We are working alongside Clover Therapeutics to identify genetic variants that slow/prevent clinical progression from intermediate AMD to the advanced for of disease that could result in continuous treatment. AMD has a large genetic component; 34 common genetic variants have been discovered that are associated with AMD. A weighted polygenic risk score can classify an individuals' total level of genetic risk, and have some power to predict disease progression, in combination with environmental and clinical risk factors. Individuals with high genetic risk but that don't progress to advanced disease may have protective genetic variants. This study is a one time tele-appointment with Clover Therapeutics coupled with a DNA kit that will be sent to a consented patient's home with passive disease progression monitoring through retrieval of healthcare records for a minimum of 5 years. If you have been diagnosed with dry AMD and are interested in helping find a solution to the disease progression and being a part of innovative research, please contact our office.
We are working with Genentech Roche on an open label, Phase III long-term extension study for the medication Faricimab, for patients that have completed the Phase III TENAYA study. The primary objective is to evaluate the long-term ocular and systemic safety and tolerability of Faricimab before it is released on the market for general patient usage. Additional assessments relating to efficacy, pharmacokinetics, immunogenicity, and biomarkers will be performed.
We are working with Genentech Roche on a Phase III study to compare the efficacy and safety of Faricimab, a new anti-VEGF injection, with Eylea, one of the current standard anti-VEGF injections, in patients with neovascular age-related macular degeneration. Faricimab is the first antibody that is anti-VEGF and anti-Ang-2 designed for intravitreal use. VEGF, also known as Vascular Endothelial Growth Factor, is a molecule that causes the growth of leaky blood vessels. Anti-VEGF medications help stop the growth of new blood vessels. Ang-2, also known as angiogenesis 2, promotes destabilization of blood vessels leading to leakage and inflammation. Anti-Ang 2 stabilizes the blood vessels by reducing leakage and inflammation. This is a two year study that will be concluding in November 2021 that has shown great results for our currently enrolled study patients.
We are working with Regeneron Pharmaceuticals on a Phase II/III study to investigate the efficacy and safety of a high dose versus a 2mg dose of Aflibercept in patients with diabetic macular edema involving the center of the macula. Currently, one of the standards of treatment for this diagnosis is a 2mg injection of Eylea, but this study is collecting data to hopefully show that with a higher dose of Eylea, patients will have a better response to the medication and not have to come in as often for treatment. The primary objective of the study is to determine if treatment with highdose aflibercept HD) at intervals of 12 or 16 weeks provides non-inferior best-corrected visual acuity (BCVA) compared to 2mg aflibercept dosed every 8 weeks. In all patients, blood samples for measurement of drug concentrations (PK) and anti-drug antibody (ADA) will be obtained prior to the first treatment and at pre-specified time points throughout the course of the study. There will be approximately 640 eligible patients randomized into 3 treatment groups.
We are working with the sponsor OPTHEA on a potential new medication to treat patients with the diagnosis of wet AMD with active CVN. This study will span across 24 countries, 185 clinics and 990 participants. To date, VEGF-A is known to play a pivotal role in the development of AMD and has become a key target of treatment. The medication being tested in this study is a recombinant fusion protein that binds and neutralizes activity of VEGF-C and VEGF-D, which are thought to address the multifactorial pathogenesis of CNV formation more fully than VEGF-A inhibition alone. The Phase II of this study demonstrated improvements in visual acuity and anatomical improvements as well in treatment groups compared to sham combination and anatomical outcomes were better than the ranibizumab (Lucentis) comparable arm. The study will track patients with this particular diagnosis for a little over 2 years to collect data to compare the study medication treatment OPT-302-1004 to the medication Lucentis, which has been FDA approved to treat the diagnosis of wet AMD with active CNV by tracking visual acuity improvement and imaging.
If you are interested in participating in any of the clinical trials offered at South Coast Retina Center, please contact our office at 562-984-7024 and select