Objective To determine the time to first clinically meaningful improvement in best-corrected visual acuity (BCVA) in patients treated with ranibizumab for diabetic macular oedema (DME) and identify predictors of early visual improvement.
Methods and analysis We retrospectively analysed the phase III RIDE (NCT00473382) and RISE (NCT00473330) trials, in which 759 patients with DME were randomised to monthly intravitreal ranibizumab 0.3 mg (n=250), ranibizumab 0.5 mg (n=252) or sham treatment (n=257). After month 24, 191 sham-treated patients crossed over to monthly ranibizumab 0.5 mg through month 36, while ranibizumab-treated patients continued treatment. Kaplan-Meier analyses assessed time to achieve ≥15 or ≥10 Early Treatment Diabetic Retinopathy Study (ETDRS) letter gains from baseline or ≥20/40 Snellen equivalent BCVA in each treatment arm. Baseline predictors of ≥15 ETDRS letter gains at month 6 were identified by logistic regression.
Results Median time to first ≥15 ETDRS letter gain was significantly shorter in patients who received ranibizumab (0.3 mg, 11.1 months; 0.5 mg, 10.9 months) than sham-treated patients who crossed over to ranibizumab 0.5 mg at month 24 (35.7 months; both p<0.0001). Half of ranibizumab-treated patients achieved ≥20/40 BCVA within 2.3 (0.3 mg) and 1.9 months (0.5 mg). Baseline predictors of early vision improvement among ranibizumab-treated patients were BCVA ≤55 ETDRS letters, younger age and presence of subretinal fluid.
Conclusion Prompt ranibizumab therapy for DME was associated with rapid, clinically meaningful vision gains that were maintained over 36 months of treatment. Lower BCVA, younger age and presence of subretinal fluid were predictive of early vision improvement.
- Diabetic macular oedema
- visual acuity
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Presented at Data reported herein were presented in part at the Association for Research in Vision and Ophthalmology 2013 Annual Meeting, May 2013, Seattle, Washington, USA.
Contributors LM and LT contributed to the design and conduct of the study and data collection. LM, LY and LT contributed to data analysis, interpretation and critical review and final approval of the manuscript. LM contributed to provision of materials, patients or resources. LY contributed to statistical expertise.
Funding Genentech, Inc., a member of the Roche Group, provided financial support for the study, participated in the design and conduct of the study and was involved in data collection, management and interpretation. Third-party writing assistance, provided by Karina D. Hamilton-Peel, PhD, Jack W. Pike, PhD and Kathryn H. Condon, PhD, of Envision Pharma Group, was funded by Genentech, Inc.
Competing interests LM serves as a consultant for Allergan, Genentech, Inc. and Iridex. LY and LT are employees of Genentech, Inc.
Patient and public involvement statement Patient and public involvement was not sought for the design, conduct and reporting of this study.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
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