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Background: To evaluate the safety and efficacy of a treat-and-extend protocol of aflibercept for cystoid macular oedema (CMO) secondary to central retinal vein occlusion (CRVO)., Methods: Twenty patients with CMO secondary to CRVO were included in this prospective cohort study. After 3 loading 4-weekly injections, treatment intervals were increased by 2 weeks if there was no clinical activity, to a maximum of 12 weeks. If clinical activity recurred or persisted, the interval between injections was shortened by 2 weeks, to a minimum of 4 weeks. Main outcome measures were change in visual acuity and the proportion of patients gaining 15 or more Early Treatment of Diabetic Retinopathy Study (ETDRS) letters from baseline at 6, 12 and 18 months., Results: Mean BCVA gain from baseline was 19.7 ± 13.8, 22.2 ± 13.9 and 21.9 ± 15.8 ETDRS letters at 6, 12 and 18 months, respectively. Sixty-five percent of patients gained 15 or more ETDRS letters at 6 months, increasing to 70.6% at 12 and 18 months. Patients received 5.0 [4.0 to 6.0], 8.5 [8.0 to 10.3] and 11.0 [9.0 to 12.5] injections by 6, 12 and 18 months, respectively., Conclusions: The visual outcomes achieved with a treat-and-extend protocol in this study were similar to the pivotal trials of aflibercept for CMO secondary to CRVO, which used monthly and then as-needed protocols., Trial Registration: Australian and New Zealand Clinical Trials Registry, registration number ACTRN12615000417583, 01/05/2015.

To evaluate the reporting of harms by randomised controlled trials investigating intravitreal therapies for diabetic macular oedema. A thorough literature search identified eligible reports. Two authors independently extracted data from these articles using a prospectively created checklist. The main outcome measure was compliance with the 10 recommendations of the 2004 Consolidated Standards of Reporting Trials statement extension for better harms reporting. Secondary outcomes were the predictors of the number of recommendations met and the amount of space devoted to harms reporting. Thirty-six reports involving 7246 eyes met the criteria for analysis. The fidelity of the data extraction was excellent, with Cohen's κ coefficient of 0.90 for all items extracted. The median number of recommendations met was six, IQR 5-7. Recommendation 4 (describe how harms-related information was collected) was met by 97% of articles and recommendation 8 (present the absolute risk of each adverse event) by 92%. The least frequently met recommendations were numbers 3 (list addressed adverse events with definitions of each), 31%, and 6 (describe participant withdrawals because of harms), 36%. The mean percentage of the results section devoted to harms-related data was 25.8%, SD 10.8%. Harms reporting in published reports of trials of intravitreal therapies for diabetic macular oedema is still not entirely adequate despite increased attention and efforts to standardise it., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)