Clinical Studies: Protocol V

Summarized by Kyle Kovacs, MD (Weill Cornell Medicine Department of Ophthalmology) and Ben Botsford, MD

Citations: Baker CW, Glassman AR, Beaulieu WT, et al. Effect of Initial Management With Aflibercept vs Laser Photocoagulation vs Observation on Vision Loss Among Patients With Diabetic Macular Edema Involving the Center of the Macula and Good Visual Acuity: A Randomized Clinical Trial. JAMA. 2019;321(19):1880–1894. doi:10.1001/jama.2019.5790

Key Points

  • Protocol V was a double-blind, randomized clinical trial enrolling Type 1 or Type 2 diabetic eyes with central involving macular edema and good vision (20/25 or better)
  • There was no significant difference in eyes initially managed with aflibercept, laser, or observation and given aflibercept only if vision worsened, suggesting that observation without treatment unless vision worsens is a reasonable strategy
  • Objective

    To compare vision loss at 2 years among eyes with center involving macular edema and vision of 20/25 or better when initially managed with aflibercept, laser photocoagulation, or observation.


    Phase 3, multicenter, randomized, double-masked, treatment-controlled trial

  • Duration

    2 years


Randomization scheme and interventions:


Study Population:

Injections Performed

Primary outcome (% eyes with >5-letter visual acuity decrease at 2 years)- no significant difference

Mean change in visual acuity letter score (secondary outcome)- no significant difference

Change in retinal thickening (central subfield thickness)- no significant difference

Adverse Events: