Benefit from Bevacizumab for Macular Edema in Central Retinal Vein Occlusion: Twelve-Month Results of a Prospective, Randomized Study

• Published in: Ophthalmology (Rochester, Minn.) Vol. 119; no. 12; pp. 2587 - 2591
• Main Authors: Epstein, David L., MD, Algvere, Peep V., MD, PhD, von Wendt, Gunvor, MD, PhD, Seregard, Stefan, MD, PhD, Kvanta, Anders, MD, PhD
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.12.2012; Elsevier
• Subjects: Aged; Angiogenesis Inhibitors - therapeutic use; Antibodies, Monoclonal, Humanized - therapeutic use; Bevacizumab; Biological and medical sciences; Double-Blind Method; Female; Gonioscopy; Humans; Intravitreal Injections; Macular Edema - drug therapy; Macular Edema - etiology; Macular Edema - physiopathology; Male; Medical sciences; Medicin och hälsovetenskap; Miscellaneous; Ophthalmology; Prospective Studies; Retinal Vein Occlusion - complications; Retinal Vein Occlusion - physiopathology; Retinopathies; Tomography, Optical Coherence; Treatment Outcome; Vascular Endothelial Growth Factor A - antagonists & inhibitors; Visual Acuity - physiology; Antineoplastic agent; Retinopathy; Cardiovascular disease; Retinal edema; Monoclonal antibody; Venous disease; Bevacizumab; Vascular disease; Immunomodulator; Prospective; Central retinal vein occlusion; Eye disease; Vascular endothelium growth factor; Ophthalmology; Antiangiogenic agent
• ISSN: 0161-6420; 1549-4713; 1549-4713
• DOI: 10.1016/j.ophtha.2012.06.037

Purpose To evaluate the efficacy of intraocular injections with bevacizumab over 12 months in patients with macular edema (ME) secondary to central retinal vein occlusion (CRVO). Design A prospective study including a randomized 6-month, sham injection-controlled, double-masked clinical trial followed by a 6-month open-label extension. Participants Sixty patients with ME secondary to CRVO. Methods At baseline, patients were randomized 1:1 to receive intraocular injections of bevacizumab or sham injections every 6 weeks for 6 months. From month 6, all patients received intraocular injections of bevacizumab every 6 weeks for 6 months. Main Outcome Measures The primary outcome measure was the proportion of patients gaining at least 15 letters at 12 months. Secondary outcome measures included mean change from baseline best-corrected visual acuity (BCVA), change in foveal thickness, and development of neovascular glaucoma. Results At the end of follow-up, 18 of 30 patients (60.0%) in the bevacizumab/bevacizumab (bz/bz) group had gained ≥15 letters compared with 10 of 30 patients (33.3%) in the sham/bevacizumab (sh/bz) group ( P < 0.05). The BCVA improved by 16.0 letters at 12 months in the bz/bz group compared with 4.6 letters in the sh/bz group ( P < 0.05). In an unplanned retrospective analysis, patients aged >70 years had a significantly worse outcome when receiving delayed treatment, losing 1.4 letters (95% confidence interval [CI], −9.7 to 8.4) in the sh/bz group compared with a gain of 20.1 letters (95% CI, 13.9–26.3) in the bz/bz group in patients aged <70 years ( P < 0.003). The mean decrease in central retinal thickness (CRT) was 435 μm in the bz/bz group compared with 404 μm in the sh/bz group ( P = not significant). No patients developed iris rubeosis during the 6-month open-label extension period. There were no events of endophthalmitis, retinal tear, or retinal detachment during the 12-month treatment period. No serious nonocular adverse events were reported. Conclusions Intraocular injections of bevacizumab given every 6 weeks for 12 months improve visual acuity (VA) and reduce ME significantly. Patients receiving delayed treatment have a limited visual improvement. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references.