Southeastern Retina Associates Clinical Trials Research Program
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 400 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.
Kristina Oliver at our Weisgarber office 865.588.0811 or Baptist office 865.579.3999
Paula Clark 423.756.1002
Tabetha Miller 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
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 areds2.org
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.
To learn more about CATT:
- Comparison of Age-Related Macular Degeneration Treatments Trials (CATT)
- Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial
One year results for the CATT trial were released on April 28th, 2011. For additional information:
- NIH study finds Avastin and Lucentis are equally effective in treating age-related macular degeneration
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 visit the website DRCR.net
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.
The SAKURA study, sponsored by Santen, Inc. is a Phase III, Multinational, Multicenter, Randomized, Double-Masked, Study Assessing the Safety and Efficacy of Intravitreal Injections of DE-109 (three doses) for the Treatment of active, Non- Infectious Uveitis of the Posterior Segment of the eye.
ALCON C-09-067 STUDY (RACE) (Tri-Cities)
A controlled, double-masked, randomized, multicenter study to evaluate AL-78898A verses Lucentis as a treatment of exudative AMD.
THROMBO genics tg-mv-005 (Tri-Cities)
A randomized, sham injection controlled, doublemasked, multicenter trial, of Ocriplasmin Intravitreal Injection for treatment of focal vitreomacular adhesion in subjects with exudative age related Macular Degeneration.
ALIMERA C-01-11-008-(FAME) (Tri-Cities)
An Open Label, Multi-center Extension Study of the Safety and Utility of the New Inserter of ILUVIEN® (Fluocinolone Acetonide Intravitreal Insert) 0.19 mg and the Safety of ILUVIEN in Subjects with Diabetic Macular Edema.