Southeastern Retina Associates is proud of its participation in research studies demonstrating the highest professional standards and exemplary clinical practice. SERA physicians have been leading clinical trials for more than 15 years! Patient participation in trials is voluntary, and has allowed the latest treatments to become available to all patients who need treatment for advanced eye diseases. More than 75 SERA patients have taken part in the research trials.
To ask about trials currently enrolling and the requirements to take part, patients or referring physicians make call any of SERA's Clinical Trials Coordinators listed below.
Knoxville: Tina Higdon (Weisgarber Office) 865-588-0811 OR Charity Morris (at Baptist Office) 865-579-3999
Chattanooga: Paula Clark 423-756-1002
Tri-Cities: Deanna Long 423-578-4364
Below, in alphabetical order, are descriptions of clinical trials in progress (enrolling or following) at Southeastern Retina Associates' three East Tennessee main locations. More information on clinical trials is available at clinicaltrials.gov
ALIMERA SCIENCES (Tri-Cities)
This is a randomized, double-masked, sham injection - controlled, parallel-group multicenter phase III, 3-year study comparing the safety and efficacy of fluocinolone acetonide intravitreal inserts in subjects with diabetic macular edema. Alimera Sciences is the company that sponsors the study.
AREDS2 (Knoxville, Tri-Cities)
Age-Related Eye Disease Study 2 (AREDS2) is a multi-center, randomized trial designed to assess the effects of oral supplementation of macular xanthophylls (lutein and zeaxanthin) and/or long-chain omega-3 fatty acids (docosahexaenoic acid, or DHA) and eicosapentaenoic acid, or EPA) on the progression to advanced age-related macular degeneration (AMD). An additional goal of the study is to assess whether forms of the AREDS nutritional supplement with reduced zinc and/or no beta-carotene works as well as the original supplement in reducing the risk of progression to advanced AMD. For more information go to areds1.org
BRAVO (Knoxville)
This study is a phase III, multicenter, randomized, double-masked, sham injection-controlled study of the efficacy and safety of intravitreal ranibizumab compared with sham injections in subjects with macular edema secondary to branch retinal vein occlusion (BRVO). Approximately 390 subjects with BRVO will be randomized at approximately 100 investigational sites in the United States. Genentech, Inc., sponsors the BRAVO studies.
CATT (Knoxville)
CATT (Comparison of Age-related Macular Degeneration Treatment Trials) is sponsored by the National Eye Institute and compares four treatment plans for wet age-related macular degeneration (AMD), the leading cause of severe vision loss in people over 50 years old. The latest treatments include drug injections directly into the eye. Avastin and Lucentis have both proven to slow vision loss and sometimes improve vision. However, the current study will determine if Avastin® is more effective, less effective, or the same as Lucentis® for treating wet AMD. Read more at http://www.med.upenn.edu/cpob/studies/CATT.shtml OR http://clinicaltrials.gov/ct2/show/NCT00593450
CRUISE (Knoxville)
This study is a phase III, multicenter, randomized, double-masked, sham injection-controlled study of the efficacy and safety of intravitreal ranibizumab compared with sham injections in subjects with macular edema secondary to central retinal vein occlusion (CRVO). Approximately 390 subjects with CRVO will be randomized at approximately 100 investigational sites in the United States. Genentech, Inc. sponsors the CRUISE studies.
DRCR (Knoxville, Tri-Cities)
Diabetic Retinopathy Clinical Research Network (DRCR.net) facilitates multicenter clinical research of diabetic retinopathy, diabetic macular edema and associated conditions. DRCR studies examine the use of laser treatment and injections in the treatment of either diabetic retinopathy or diabetic macular edema. Several protocols are available.
DRCR.net was formed in September 2002 and currently includes more than 199 participating sites with more than 670 physicians in the U.S. The studies are funded by the National Eye Institute, a part of the National Institutes of Health, which is the branch of the federal government that funds medical research. For more information go to the public Web site at DRCR.net
FENRETINIDE (Knoxville)
The fenretinide study is a phase II, multicenter, randomized, double-masked, placebo-controlled, dose-comparison of the safety and efficacy of fenretinide in the treatment of geographic atrophy in subjects with the dry form of age-related macular degeneration (AMD). The study is sponsored by SIRION Therapeutics.
HORIZON 2 (Knoxville)
Horizon 2 is an open-label, multicenter, extension study of intravitreally administered ranibizumab in subjects with macular edema secondary to RVO who have completed the 6-month treatment and 6-month observation phases (12 months total) of a Genentech sponsored study (BRAVO or CRUISE). The HORIZON 2 study will evaluate the safety and tolerability of ranibizumab.
POSURDEX (Knoxville)
The Posurdex study, sponsored by Allergan, Inc., will evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with diabetic macular edema.
THROMBOGENICS (Tri-Cities)
This study is a randomized, placebo controlled, double-masked, multicenter trial of microplasmin intravitreal injection for non-surgical treatment of focal vitreomacular adhesion. The study is sponsored by Thrombogenics, a biopharmaceutical company.