Abstract
BackgroundTo evaluate the efficacy and safety of two individualized ranibizumab retreatment schemes in neovascular age-related macular degeneration.MethodsPatients (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 and the decision to discontinue the study was made by the sponsor. 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.ResultsOf 671 randomized patients, 305 completed 12 months of the study. For the 12-month completers, baseline mean (standard deviation) BCVA and reading-center evaluated central subfield thickness (CSFT) were comparable [Group I: 60.9 (13.10) letters and 517.7(201.79) μm; Group II: 60.2 (12.21) letters and 515.3 (198.37) μm]. 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 ranibizumab injections was 8.2 in Group I and 8.4 in Group II.ConclusionRanibizumab 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.Trial registrationwww.ClinicalTrials.gov (NCT01780935). Registered 31 January 2013.
Highlights
To evaluate the efficacy and safety of two individualized ranibizumab retreatment schemes in neovascular age-related macular degeneration
The decision to discontinue the study was made by the sponsor after optical coherence tomography (OCT)-guided monitoring of disease activity has been included in the posology for ranibizumab and due to the updated label approved for disease activity
OCT And Vision Evaluation (OCTAVE) was conducted according to the principles of the Declaration of Helsinki and the study protocol was reviewed by the Independent Ethics Committee or Institutional Review Board for each study center
Summary
Study design OCTAVE was an open-label, phase IIIb, randomized, double-masked (with regard to the retreatment criteria) study that was originally planned to have a 24-month duration (Fig. 1), but was terminated earlier than planned (October 2014). Patients Patients included were ≥ 50 years of age with visual impairment due to nAMD; with active, newly diagnosed, angiographically documented choroidal neovascularization (CNV) secondary to AMD in a previously untreated eye; and with CNV or its sequelae (i.e., pigment epithelium detachment, subretinal or subretinal pigment epithelial hemorrhage, blocked fluorescence, macular edema, or subretinal, subretinal pigment epithelial or intraretinal fluid [IRF]) involving the center of the fovea, and a BCVA score at both screening and baseline between 78 and 23 letters inclusive (approximate Snellen equivalent of 20/32 and 20/320) If both eyes were eligible for the study, a single study eye was selected at screening by the investigator based on clinical judgement and the decision was confirmed at the baseline visit. The mean (SD) CSFT decreased from baseline over time (Fig. 4) and at Month 12 was − 161.3 (163.48) μm in Group I and − 175.3 (170.45) μm in Group II
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