Clinical Studies:

DRCR Protocol W

Summarized by Matthew R. Starr, MD (Wills Eye Hospital, Mayo Clinic)

Citation:  Maturi RK, Glassman AR, Josic K, et al. Effect of Intravitreous Anti-Vascular Endothelial Growth Factor vs Sham Treatment for Prevention of Vision-Threatening Complications of Diabetic Retinopathy: The Protocol W Randomized Clinical Trial. JAMA Ophthalmol. Published online March 30, 2021. doi:10.1001/jamaophthalmol.2021.0606

  • Objective

    To determine the efficacy of aflibercept versus sham in preventing progression to PDR or DME in eyes with moderate to severe NPDR without DME.


    Double-masked, randomized, prospective clinical trial.


    24 Months

Clinical Trial Guide Video Thumb Watch VBS members discuss this study on New Retina Radio Journal Club

With Yoshihiro Yonekawa, MD; Ajay Kuriyan, MD; Anton Orlin, MD; and Paula Pecen, MD



Randomized 1:1 to

(a) aflibercept 2 mg 1, 2, and 4 months, and then every 4 months for 2 years unless DRSS was less than 35 (mild NPDR)

(b) sham injections

Retreatment criteria with aflibercept for both groups if developed DME with 10% increase in CST from baseline along with 10 letter decrease in VA or 5-9 letter loss for 2 consecutive visits or if developed high-risk PDR. PRP was performed if aflibercept therapy failed.

RESULTS (52 months)

Study population

Treatment effect on DR and DME

Visual acuity end-points

Adverse events