SCORE study updates announced

Triamcinolone acetonide injections for macular edema associated with retinal vein occlusion have become a therapeutic mainstay, but conflicting data have emerged about the safety of these injections, and some reports indicate that visual stabilization rather than visual improvement is occurring.

The SCORE study has been launched to provide long-term data on the safety and efficacy of this treatment approach, and more than 400 patients have now been enrolled at 82 clinical sites, according to Ingrid U. Scott, MD, MPH, professor of ophthalmology and health evaluation science, Penn State College of Medicine, Hershey, PA.

"This is expected to be a definitive trial on the role of intravitreal triamcinolone for macula edema associated with retinal vein occlusion with a 1-year primary outcome assessment," Dr. Scott said.

SCORE (Standard Care versus Corticosteroid for Retinal Vein Occlusion) is a randomized, controlled, multicenter phase III trial begun in 2003 and funded by the National Eye Institute. Separate trials are being conducted under the SCORE umbrella for central retinal vein occlusion and for branch retinal vein occlusion. In both trials, patients are randomized 1:1:1 to 1 mg of steroid, 4 mg of steroid, or standard care.

"The SCORE study is a collaborative effort among ophthalmologists in both private practice and academia, the National Eye Institute, regulatory agencies, and an industry partner. This study provides us the opportunity to find an effective treatment for patients with central retinal vein occlusion and a more effective treatment for branch retinal vein occlusion," Dr. Scott said.

Intravitreal corticosteroid injections for macular edema associated with retinal vein occlusion were introduced in 1999, and initial reports appeared promising, with dramatic improvements in macular edema and visual acuity in some patients to a level that had not been previously reported, Dr. Scott said. This therapeutic intervention was widely adopted, but the relative lack of long-term follow-up data and new questions about safety and effectiveness prompted the design of the SCORE study.