VA still improved at 5 years in Protocol T extension study
Two-thirds of Protocol T participants who were followed up at 5 years maintained mean visual acuity improvement relative to baseline, but experienced visual acuity decreases from year 2 to 5.
“However, no significant changes in OCT thickness occurred during this time period,” Dante J. Pieramici, MD, said at the virtual American Society of Retina Specialists meeting.
Protocol T was a randomized, multicenter clinical trial that included 660 patients with center-involved diabetic macular edema. The participants were treated with anti-VEGF injections of aflibercept, bevacizumab or ranibizumab and researchers evaluated the change in visual acuity after 2 years.
The Protocol T extension followed 317 eligible participants with diabetic macular edema through 5 years. Researchers evaluated the primary objectives of treatment course, visual acuity and central subfield thickness changes from baseline.
Between years 2 and 5, the mean number of anti-VEGF injections in the cohort was four, with 68% of participants receiving at least one injection. Additionally, the median number of visits with a retina specialist was 12.
On average, the visual acuity of the participants at year 5 was a gain of 7.4 letters from baseline, but a loss of 4.7 letters from the mean visual acuity of 12.2 letters gained at year 2. Despite the visual acuity losses between years 2 and 5, nearly 50% of participants were 20/25 or better and 75% were 20/40 or better at year 5, Pieramici said.
OCT results did not change much during the extension period, Pieramici said in the discussion of the study. The average central subfield thickness loss from baseline to year 5 was on average 154 µm but showed no substantial changes from central subfield thickness averages at 2 years.
“Strategies to improve long-term visual outcomes in clinical care among eyes with DME are needed,” he said.
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Pieramici DJ. Five-year outcomes after initial aflibercept, bevacizumab or ranibizumab treatment for diabetic macular edema (Protocol T). Presented at: American Society of Retina Specialists annual meeting; July 24, 2020 (virtual meeting).
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