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SCORE2 to explore primary, secondary therapies for CRVO

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WAILEA, Hawaii — A new study is designed to examine first- and second-line treatments for central retinal vein occlusion, a speaker told colleagues here.

Michael S. Ip, MD, discussed design protocols for the Study of Comparative Treatments in Retinal Vein Occlusion 2 (SCORE2) at Retina 2015.

Michael S. Ip

“There are now multiple treatments for CRVO supported by level 1 evidence. Each approach has unique limitations and advantages. There are multiple anti-VEGF agents available. Anti-VEGF agents may be more efficacious. Corticosteroids are likely to have an inferior adverse event profile,” Ip said.

SCORE2, an investigator-initiated, randomized, controlled multicenter clinical trial, will include 360 patients with macular edema associated with CRVO; 180 patients will receive Eylea (aflibercept, Regeneron) and 180 patients will receive Avastin (bevacizumab, Genentech). Injections in both study arms will be on a monthly or treat-and-extend basis.

The primary outcome measure at 6 months will be the mean change in visual acuity from baseline. Investigators will determine whether patients have a good, poor or marginal response to primary therapy at 6 months.

Patients with a good response to aflibercept or bevacizumab at 6 months will be randomized 1:1 to receive the same treatment on a monthly or treat-and-extend basis. The treat-and-extend protocol involves 2-week extension increments.

Patients with a poor or marginal response to aflibercept at 6 months will receive Ozurdex (dexamethasone implant, Allergan). Those who respond poorly or marginally to bevacizumab will be switched to aflibercept.

Change in visual acuity from 6 to 12 months will be compared with the change from randomization to month 6 within each treatment arm, Ip said.

About 80 participants have been randomized, he said.

“I think that even with the dissemination of SCORE2 results, there will still remain many unanswered questions. We are fortunate to have so many options available. Over time, with further study, we’ll have more of a consensus opinion with respect to how to manage our CRVO patients,” Ip said. – by Matt Hasson and Patricia Nale

Disclosure: Ip is a consultant for Alimera and ThromboGenics.