Diabetic Retinopathy Clinical Research Network – Protocol W

Active Clinical Trials // Feb 14 2017

sponsored by JAEB

*Diabetic Retinopathy Clinical Research Network – Protocol W Intravitreous Anti-VEGF Treatment for Prevention of Vision Threatening Diabetic Retinopathy in Eyes at High Risk *

Principal Investigator: Justin Gottlieb, MD

Study Coordinator(s): 

  • Kris Dietzman
  • Chris Smith

Study Objective

The objectives of this study are to 1) determine the efficacy and safety of intravitreous aflibercept injections versus sham injections (observation) for prevention of PDR or CI-DME in eyes at high risk for development of these complications and 2) compare long-term visual outcomes in eyes that receive anti-VEGF therapy early in the course of disease with those that are observed initially, and treated only if high-risk PDR or CI-DME with vision loss develops.

Study Design

Phase III, multi-center randomized clinical trial

Major Eligibility Criteria

  • Age ≥ 18 years
  • Type 1 or type 2 diabetes
  • Study eye with:
  • Best corrected Electronic-ETDRS (E-ETDRS) visual acuity letter score in the study eye ≥79 (approximate Snellen equivalent 20/25 or better)
  • Severe NPDR (based on the 4:2:1 rule) on clinical examination and on digital imaging as judged by the investigator, confirmed by Reading Center grading prior to randomization as ETDRS level 47B to 53E
  • No evidence of neovascularization on fluorescein angiography within the 7-modified ETDRS fields, confirmed by Reading Center grading.
  • No clinical exam evidence of neovascularization including active neovascularization of the iris (small iris tufts are not an exclusion) or angle neovascularization (if the angle is assessed).
  • No prior PRP (defined as ≥ 100 burns placed previously outside of the posterior pole)
  • No CI-DME on clinical exam and OCT central subfield thickness below the following gender and OCT-machine specific thresholds:
    • Zeiss Cirrus: 290µm in women and 305µm in men
    • Heidelberg Spectralis: 305µm in women and 320µm in men
  • No history of DME or DR treatment with laser or intraocular injections of medication within the prior 12 months and no more than 4 prior intraocular injections at any time in the past.

Treatment Groups

Study eyes will be assigned randomly (1:1) to one of the following two groups:

  • Sham injections
  • Intravitreous 2 mg aflibercept injections

Study participants may have one or two study eyes. Study participants with two study eyes will receive intravitreous aflibercept in one eye and sham injection in the other eye. Further details on randomization are located in section 2.4.

Injections (intravitreous or sham) will be given at baseline, 1 and 2 months in all participants. Thereafter, injections will be given at each 4-month visit until 2 years. At and after the 2-year visit, retreatment with injections (intravitreous or sham) will be based on DR level, as assessed by the investigator.

Duration of Follow up

  • Primary outcome: 2 years
  • Total follow-up: 4 years

Follow up Schedule

  • All participants will have visits at 1 month, 2 months, and 4 months, followed by visits every 4 months thereafter through 4 years.
  • Eyes may be seen more frequently depending on disease progression and treatment administered

For more information pleas contact Kris Dietzman at 608-263-9035, or Chris Smith at 608-263-7169