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Peter A. Campochiaro, Gulnar Hafiz, Raafay Sophie, Diana V. Do, Adrienne W. Scott, Quan D. Nguyen, Sharon Solomon, Akrit Sodhi, Elia Duh, Howard Ying; Ranibizumab Dose Comparison (0.5mg And 2.0mg) And The Role Of Laser In The Management Of Retinal Vein Occlusion (RELATE) Trial Interim Report. Invest. Ophthalmol. Vis. Sci. 2012;53(14):917.
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To compare the effects of injections of 0.5mg or 2mg of ranibizumab (RBZ) every month for 6 months in patients with central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO).
Interim report of a double-masked, randomized trial in which 25/40 patients with BRVO (0.5mg, 13; 2mg, 12) and 24/40 patients with CRVO (0.5mg, 13; 2mg, 11) have reached the 6 month primary endpoint.
The baseline characteristics in patients with BRVO in the 0.5mg and 2mg groups were: mean age, 65.9 and 70.8; mean duration from RVO diagnosis to study entry, 16.4 and 24.8 months; BCVA, 20/80 and 20/100; CFT, 439.5µm and 568.3µm. At the 6 month primary endpoint, the mean improvement in BCVA in the 0.5mg and 2mg groups was 8.6 and 11.7 letters, the percentage of patients in the 0.5mg and 2mg groups that gained ≥15 letters, ≥10 letters, or ≥5 letters was 15.4 and 41.7, 53.8 and 58.3, 61.5 and 83.3, and the mean improvement in CFT was 200.3µm and 261.8µm. The baseline characteristics in patients with CRVO in the 0.5mg and 2mg groups were: mean age, 55.0 and 61.6; mean duration from RVO diagnosis to study entry, 11.9 and 17.8 months; BCVA, 20/100 and 20/100; CFT, 573.5µm and 614.6µm. At the 6 month primary endpoint, the mean improvement in BCVA in the 0.5mg and 2mg groups was 14.0 and 15.1 letters, the percentage of patients in the 0.5mg and 2mg groups that gained ≥15 letters, ≥10 letters, or ≥5 letters was 46.2 and 54.5, 76.9 and 63.6, 84.6 and 90.9, and the mean improvement in CFT was 261.2µm and 402.6µm. There were no drug-related adverse events.
There were no safety signals identified in patients receiving 0.5 or 2.0mg of RBZ for RVO. Patients with BRVO had substantially longer duration of disease than that those in BRAVO which may explain the somewhat reduced visual outcomes compared to BRAVO. Compared to BRVO patients treated with 0.5mg RBZ, a greater percentage treated with 2.0mg improved by ≥15 letters. Despite longer duration of disease in the CRVO patients that received 2.0mg RBZ, both the 0.5mg and 2.0mg groups had excellent visual outcomes. Results from the complete study population may provide important insights.
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