A 12-month prospective trial of inject and extend regimen for ranibizumab treatment of age-related macular degeneration.

ABSTRACT

PURPOSE: To evaluate the safety and efficacy of a strictly applied inject and extend protocol for ranibizumab treatment of age-related macular degeneration. METHODS: This is a prospective, multicenter, nonrandomized trial. Patients underwent standard induction with 3 intravitreal doses of 0.5 mg ranibizumab, each 1 month apart. Following this induction, patients were evaluated and received an injection at each visit. If they did not meet set criteria for signs of exudative disease the interval to the next visit was extended by 2 weeks and if exudative disease was present the interval was shortened by 2 weeks. RESULTS: Vision improved by 1.3 lines (P = 0.008); 26% gained ≥3 lines of vision, 74% lost no lines of vision, and 95% avoided loss of ≥3 lines of vision. CONCLUSION: This study shows that the Inject and Extend protocol is safe and efficacious for the treatment of age-related macular degeneration. Head-to-head studies are needed to compare directly with other regimens currently in use, as well as economic analysis to investigate the financial implications.