Long-term outcomes in patients with retinal vein occlusion treated with ranibizumab: the RETAIN study.

OBJECTIVE: To determine long-term outcomes of patients with ranibizumab-treated retinal vein occlusion (RVO).

DESIGN: Prospective follow-up of a subset of patients from 2 phase 3 trials.

PARTICIPANTS: Thirty-four patients with branch RVO (BRVO) and 32 with central RVO (CRVO) who completed the Genentech-sponsored ranibizumab study RVO trials.

METHODS: Patients seen every month in year 1 and at least every 3 months in year 2 were treated with ranibizumab for intraretinal fluid. Patients requiring injections on consecutive visits were treated with ranibizumab plus scatter photocoagulation.

MAIN OUTCOME MEASURES: Mean improvement in best-corrected visual acuity (BCVA) and percentage of patients with edema resolution.

RESULTS: With a mean follow-up of 49.0 months, 17 of 34 BRVO patients (50%) had edema resolution defined as no intraretinal fluid for 6 months or more after the last injection. The last injection was given within 2 years of treatment initiation in 76%. The mean number of injections required in unresolved patients in year 4 was 3.2. In patients with resolved edema mean improvement in BCVA was 25.9 letters versus 17.1 letters (P = 0.09) in unresolved patients, and in both groups, approximately 80% had a final BCVA of 20/40 or better. With a mean follow-up of 49.7 months, 14 of 32 CRVO patients (44%) had edema resolution, with 71% receiving their last injection within 2 years of treatment initiation. The mean number of injections in unresolved patients in year 4 was 5.9. Compared with patients with unresolved CRVO, patients with resolved disease had greater improvement in BCVA (25.2 vs. 4.3 letters; P = 0.002), and a greater percentage had a final BCVA of 20/40 or better (64.3% vs. 27.8%; P = 0.04). Nine patients with BRVO and 9 with CRVO received scatter photocoagulation, and with mean follow-up of 9 months (BRVO) and 11 months (CRVO) after last laser, only 1 in each group had resolution of edema.

CONCLUSIONS: Long-term outcomes in BRVO patients treated with ranibizumab were excellent, and although half still required occasional injections after 4 years, they maintained good visual potential. A substantial minority (44%) of patients with ranibizumab-treated CRVO had edema resolution and a good outcome within 4 years, but most (56%) still required frequent injections, had reduced visual potential, and have a guarded prognosis.