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Jennifer K Sun; Clinically Relevant Outcomes from the DRCR.net Anti-VEGF Treatment Algorithm for Proliferative Diabetic Retinopathy. Invest. Ophthalmol. Vis. Sci. 2018;59(9):735.
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To assess clinically relevant outcomes such as neovascular status and treatment burden needed over 2 years when using the DRCR.net proliferative diabetic retinopathy (PDR) anti-VEGF treatment algorithm.
The DRCR.net Protocol S enrolled 394 study eyes with PDR from 305 participants, and randomly assigned these to 0.5-mg ranibizumab (N = 191) or PRP (N = 203). Eyes assigned to ranibizumab received 6 monthly injections starting at baseline unless retinal neovascularization (NV) resolved completely at 4 or 5 months. After the initial 6 months, if NV was stable over 2 consecutive visits, injections could be deferred. If NV worsened subsequently, anti-VEGF treatment resumed. PRP could be initiated for failure or futility criteria. Ranibizumab was given for central-involved diabetic macular edema (CIDME) at baseline and at investigator discretion for CIDME during follow-up.
At 1 month, NV had resolved completely in 19% of eyes assigned to ranibizumab (35/188) and an additional 60% (113/188) were improved. At 6 months, 52% of eyes (80/153) had NV resolution, 3% (4) were still improving, 37% (56) were stable, 8% (13) had worsened NV since the last visit, and 1% (2) had received PRP. At visits between 6 months and 2 years, NV was resolved, stable or improved in ~70-90% of eyes. Of 69 eyes in which at least one injection was deferred for sustained stability, 26% (18) deferred injection for only 1 visit, 20% (14) deferred for two consecutive visits, 54% (37) deferred for 3 or more consecutive visits, and 16% (11) never received another injection. Among eyes with resolved (N=80) versus non-resolved NV (73) at 6 months, the median (interquartile range) number of injections between 6 months and 2 years was 4 (1, 7) versus 7 (4, 11) (P<0.001).
Although consideration of individual patient needs must guide specific treatment decisions for PDR, the DRCR.net anti-VEGF treatment algorithm for PDR can provide excellent clinical outcomes through 2 years, with the vast majority of eyes having resolved, stable or improved NV at each visit. Since it is unknown if less frequent dosing or longer follow-up intervals might result in more frequent NV recurrence, caution is advised with such approaches. Additional data through 5 years from this ongoing study will reveal longer-term safety and visual outcomes as well as the durability of ranibizumab’s effect on PDR regression.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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