Clinical Trial Results

Recent CRC Clinical Trial Study Results

Randomized Trial Comparing Intravitreal Triamcinolone to Focal/Grid Photocoagulation for Diabetic Macular Edema (DRCR Protocol)

A national, multi-center clinical trial organized by the Diabetic Retinopathy Clinical Research Network with support from the National Eye Institute, compared 1 mg and 4 mg doses of intravitreal triamcinolone to focal/grid photocoagulation in the treatment of patients with diabetic macular edema. The study enrolled 840 subjects and participants were monitored for three years. Results showed greater improvement in visual acuity and macular thickness within the first four months of treatment in eyes that received triamcinolone compared to focal/grid photocoagulation. However, continued examination and treatment up to three years in the study showed more efficacy and less side-effects with focal/grid photocoagulation than 1 mg or 4 mg dosing of intravitreal triamcinolone. Side-effects noted in the triamcinolone group included increased intraocular pressure and increased rate of cataract formation. Clinical trials to evaluate combination treatment with intravitreal triamcinolone and focal/grid laser are ongoing.
Reference: Archives of Ophthalmology Vol 27 Mar 2009 1447-1449

Phase III, Multicenter, Randomized, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab Injection Compared with Sham in Subjects with Macular Edema Secondary to Branch Retinal Vein Occlusion (BRAVO) and Central Retinal Vein Occlusion (CRUISE)
Genentech, Inc. announced the results of the phase III study, BRAVO and CRUISE in July 2009 press releases. BRAVO and CRUISE evaluated the use of Lucentis (ranibizumab injection) for branch and central retinal vein occlusion. This trial compared the safety and efficacy of six monthly injections of Lucentis; to monthly sham injections. Results showed early and sustained improvement over six months. Additional data will be presented later this year.
Reference: Genentech Inc. website

Phase III Clinical Trial Results – Standard Care vs. Corticosteroid
for Retinal Vein Occlusion (SCORE) Study
The Standard Care vs. Corticosteroid for Retinal Vein Occlusion (SCORE) study, conducted at 84 clinical sites, including the California Retina Consultants, found that eye injections of a corticosteroid medication could reduce vision loss related to the blockage of major blood vessels within the eye, a condition known as central retinal vein occlusion (CRVO). This is the first long-term, effective treatment to improve vision and reduce
vision loss associated with blockage of large veins in the eye. The study also demonstrated that laser therapy is equivalent to two different dosagesof corticosteroid medications for treating vision loss from the blockage of small veins in the back of the eye, a condition known as branch retinal vein occlusion (BRVO). Furthermore, laser treatment was shown to have fewer complications for patients. This research was part of a multi-center,phase III clinical trial supported by the National Eye Institute (NEI) at the National Institutes of Health. Source: NEI/NIH Press Release September 2009

Lucentis for CRVO
Data from a small clinical trial studying the effects of Lucentis in patients with CRVO were presented at the Association for Research in Vision and Ophthalmology 2009 annual meeting. Results
showed that in this small sample of patients Lucentis was tolerated quite well and most participants experienced improvement in vision after treatment. This small clinical trial designed by Dr. Dante Pieramici and colleagues helped launch larger clinical trials involving multiple medical centers across the nation.

Click here to view the ARVO 2009 Lucentis for CRVO Poster Presentation