Peter A Campochiaro1, Raafay Sophie2, Joel Pearlman3, David M Brown4, David S Boyer5, Jeffrey S Heier6, Dennis M Marcus7, Leonard Feiner8, Arun Patel3. 1. The Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland. Electronic address: pcampo@jhmi.edu. 2. The Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland. 3. Retina Consultants, Sacramento, California. 4. Retina Consultants of Houston, Methodist Hospital, Houston, Texas. 5. Retina-Vitreous Associates Medical Group, Beverly Hills, California. 6. Ophthalmic Consultant of Boston, Boston, Massachusetts. 7. Southeast Retina Center, Augusta, Georgia. 8. Retina Associates of New Jersey, Teaneck, New Jersey.
Abstract
OBJECTIVE: To determine long-term outcomes of patients withranibizumab-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 withCRVO 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 withranibizumab-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.
RCT Entities:
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.
Authors: Philip Hykin; A Toby Prevost; Sobha Sivaprasad; Joana C Vasconcelos; Caroline Murphy; Joanna Kelly; Jayashree Ramu; Abualbishr Alshreef; Laura Flight; Rebekah Pennington; Barry Hounsome; Ellen Lever; Andrew Metry; Edith Poku; Yit Yang; Simon P Harding; Andrew Lotery; Usha Chakravarthy; John Brazier Journal: Health Technol Assess Date: 2021-06 Impact factor: 4.014