Functional versus functional and anatomical criteria-guided ranibizumab treatment in patients with neovascular age-related macular degeneration – results from the randomized, phase IIIb OCTAVE study

Abstract Background: To evaluate the efficacy and safety of two individualized ranibizumab retreatment schemes in neovascular age-related macular degeneration. Methods: Patients (N=671) were randomized (1:1) to receive three initial monthly ranibizumab 0.5 mg injections, then retreatment guided by either best-corrected visual acuity (BCVA) loss (Group I) or BCVA loss and/or signs of disease activity on optical coherence tomography (OCT; Group II). The study was terminated prematurely, as OCT-guided treatment became standard of care during the study period. Post-hoc efficacy analyses were performed on patients who completed 12 months of the originally planned 24-month study. Safety analyses are presented for all safety analyzable patients. Results: Of 671 randomized patients, 305 completed 12 months. At baseline, the mean (standard deviation) BCVA and reading-center evaluated central subfield thickness (CSFT) were 60.9 (13.10) letters and 517.7(201.79) µm, respectively in Group I and 60.2 (12.21) letters and 515.3 (198.37) µm in Group II. The change from baseline at Month 12 in BCVA was 6.7 (13.48) letters in Group I and 8.3 (13.53) letters in Group II and the change in CSFT was −161.3 (163.48) µm and −175.3 (170.45) µm, respectively. The mean number of injections was 8.2 in Group I and 8.4 in Group II. Conclusion: Ranibizumab treatment resulted in visual and anatomic gains at 12 months for both retreatment strategies, with a trend in favor of OCT-guided vs BCVA loss guided retreatment. No new safety signals were seen.