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SCORE2 to compare aflibercept, bevacizumab for treating CRVO
The randomized study is also designed to assess the efficacy of second-line therapies.
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A non-inferiority comparison between aflibercept and bevacizumab as first-line treatment for macular edema associated with central retinal vein occlusion kicks off this summer, according to study committee co-chairman Michael S. Ip, MD.
The Study of Comparative Treatments in Retinal Vein Occlusion 2 (SCORE2) is designed to compare 6-month outcomes of intravitreal Avastin (bevacizumab, Genentech) and Eylea (aflibercept, Regeneron) for the treatment of macular edema secondary to CRVO. Ozurdex (dexamethasone, Allergan) will be offered as rescue therapy in one study arm.
“What we’re doing is a non-inferiority comparison between aflibercept monthly vs. bevacizumab monthly, out from baseline to month 6,” Ip, an OSN Retina/Vitreous Board Member, said in an interview with Ocular Surgery News. “Is bevacizumab non-inferior to aflibercept for central retinal vein occlusion? We’re not looking at branch retinal occlusion. We’re just looking at central retinal vein occlusion in this study.”
The National Eye Institute is funding the study, which aims to have 360 patients with CRVO enrolled by the end of the study, Ip said.
Original SCORE
Treatments approved by the U.S. Food and Drug Administration for CRVO include Lucentis (ranibizumab, Genentech), aflibercept and dexamethasone. Triamcinolone is used off label to treat CRVO, as is bevacizumab.
The SCORE-CRVO trial, published in 2009, showed intravitreal triamcinolone to be superior to observation for treating CRVO.
Michael S. Ip
“In SCORE, the landscape was totally different,” Ip said. “There were no treatments for central retinal vein occlusion at all. SCORE was actually the first group that published a paper with level 1 evidence to show that there was an intervention that altered the natural course of central retinal vein occlusion in a favorable way. We showed that, using triamcinolone, we were able to alter the natural course of vision loss associated with macular edema due to central retinal vein occlusion.”
Since results of the SCORE trial were published, anti-VEGF therapy has been shown to yield favorable visual acuity outcomes in CRVO. Ranibizumab was shown to be safe and effective in the CRUISE trial, and aflibercept was shown to be safe and effective in the GALILEO and COPERNICUS trials. Bevacizumab appears to be effective as well, based on case reports and small randomized trials, Ip said. The dexamethasone implant has demonstrated to be safe and effective in the GENEVA study. The multiple treatments now available have led to difficulty in choosing a first-line option for this condition. As well, the role of rescue therapy has not yet been defined, he said.
SCORE2 design
In SCORE2, 360 subjects will be randomized 1:1 to receive monthly intravitreal injections of bevacizumab 1.25 mg or aflibercept 2 mg for 6 months.
The study will not include a ranibizumab arm. A comparison between bevacizumab and aflibercept is needed because there has not been such a comparison between the two in the treatment of CRVO, Ip said.
“We feel that the most important comparison at the moment is the bevacizumab to aflibercept comparison,” Ip said. “Bevacizumab and ranibizumab have a similar mechanism of action in that they primarily block VEGF-A. Additionally, bevacizumab and ranibizumab, at least in other disease processes like age-related macular degeneration, have been proven to be ‘clinically similar’ in the CATT trial and a number of other clinical trials such as IVAN. At least in age-related macular degeneration, they seem to be similar.”
Non-inferiority outcomes for each treatment arm will be assessed at 6 months; outcomes will be defined as good or marginal in terms of letters of visual acuity gained and optical coherence tomography outcomes. Secondary outcomes such as safety and OCT images will be assessed at 6 months and 12 months.
Patients in the aflibercept arm who respond well to treatment will be randomized 1:1 to receive aflibercept monthly or on a treat-and-extend basis from 6 months to 11 months. Patients in the bevacizumab arm who respond well to treatment will be randomized 1:1 to receive bevacizumab monthly or on a treat-and-extend basis from 6 months to 11 months.
“Patients are moved very quickly to a treat-and-extend approach, and that’s the most commonly used approach in the United States,” Ip said. “We thought that it would be useful to show if treat-and-extend outcomes are similar to continued monthly therapy, which probably is still the gold standard when talking about maintenance of visual acuity. We’re trying to answer that as a secondary question.”
Rescue therapy — aflibercept in the bevacizumab arm and dexamethasone in the aflibercept arm — is an important element of the study, Ip said.
Patients in the bevacizumab arm who have a marginal response to initial treatment will receive aflibercept at 6, 7 and 8 months and undergo a subsequent treat-and-extend regimen. Patients in the aflibercept arm who respond marginally to initial treatment will receive dexamethasone at 6 months and as-needed at 10 months.
Investigators also plan to analyze multiple secondary visual and anatomic outcomes, Ip said. – by Matt Hasson