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US, UK trials underway to compare treatments for CRVO
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KOLOA, Hawaii — Not long ago, there were no effective treatments for central retinal vein occlusion; now there are multiple treatments, Michael S. Ip, MD, said at Retina 2017, where he updated colleagues on the SCORE2 and LEAVO trials.
Both are comparative effectiveness research trials looking at the relative safety and efficacy of anti-VEGF drugs and corticosteroids for central retinal vein occlusion. SCORE2 is a U.S. trial, and LEAVO is sponsored by the National Health Service in the U.K.
Michael S. Ip
In the U.S., anti-VEGF therapies for CRVO include the FDA-approved Lucentis (ranibizumab, Genentech) and Eylea (aflibercept, Regeneron) and off-label treatment with Avastin (bevacizumab, Genentech). Corticosteroid treatment includes FDA-approved Ozurdex (dexamethasone implant, Allergan) and off-label triamcinolone.
There is, however, little to no comparative data for these treatments, according to Ip.
“We really need these types of trials to help guide our management of these conditions,” Ip said.
It is generally agreed that anti-VEGF therapy is the most appropriate first-line therapy compared with corticosteroids due to the perception that anti-VEGF agents have fewer side effects with respect to cataract development and IOP elevation, according to the presentation.
The SCORE2 trial, a 1:1 comparison of aflibercept and bevacizumab, is fully enrolled. Primary efficacy outcome is change in visual acuity at 6 months. Based on response at 6 months, patients will be randomized again into treat-and-extend and monthly treatment groups, and a secondary outcome measure will be change in visual acuity score within each treatment arm at 12 months.
“The study design of LEAVO is notably different than SCORE2,” Ip said.
The LEAVO trial will compare bevacizumab and aflibercept in a noninferiority trial with ranibizumab, which is considered the gold standard in the U.K., Ip said.
The primary endpoint is at 100 weeks, and secondary endpoints are similar to those in the SCORE2 trial, Ip said. Recruitment for the LEAVO trial is complete.
“Both study groups are working very hard to harmonize reporting secondary outcomes ... so we will ultimately be able to combine the data sets,” Ip said. – by Patricia Nale, ELS
Reference:
Ip MS. Update on the SCORE2 and LEAVO clinical trials for central retinal vein occlusion. Presented at: Retina 2017; Jan. 16-20, 2017; Koloa, Hawaii.
Disclosure: Ip reports he is a consultant for Boehringer Ingelheim, ThromboGenics, Quark, Omeros and Genentech.