Recent CRC Clinical Trial Study Results
A Randomized Trial Comparing Intravitreal Triamcinolone to Focal/Grid Photocoagulation for Diabetic Macular
Edema (DRCR Protocol B)
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
A 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 www.gene.com
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 dosages of 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.