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DRCR.net PROTOCOL W: Intravitreous Anti-Vascular Endothelial Growth Factor vs Sham Treatment for Prevention of Vision-Threatening Complications of Diabetic Retinopathy

July 1, 2021

Clinical trial

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.

Maturi RK, Glassman AR, Josic K, Antoszyk AN, Blodi BA, Jampol LM, Marcus DM, Martin DF, Melia M, Salehi-Had H, Stockdale CR, Punjabi OS, Sun JK; DRCR Retina Network.

JAMA Ophthalmol. 2021 Jul 1;139(7):701-712.
Full text | Metrics.

Main finding: In moderate to severe nonproliferative diabetic retinopathy, the proportion of eyes that developed proliferative diabetic retinopathy (PDR) or vision-reducing centre-involved diabetic macular edema (CI-DME) was lower with periodic aflibercept compared with sham treatment. However, through 2 years, preventive treatment did not confer visual acuity benefit compared with observation plus treatment with aflibercept only after development of PDR or vision-reducing CI-DME.

 

  • Purpose: To determine the efficacy of intravitreal aflibercept injections compared with sham treatment in preventing potentially vision-threatening complications in eyes with moderate to severe NPDR.
  • Study type: Randomized controlled trial
  • Condition: Nonproliferative diabetic retinopathy

Participants: Moderate to severe NPDR without center-involved diabetic macular edema

 

  • n=328

 

Intervention:

 

Groups:

 

Group 1: Aflibercept 2mg at baseline, 1, 2, and 4 months, then every 4 months through 2 years
Group 2: Sham injection at baseline, 1, 2, and 4 months, then every 4 months through 2 years
Aflibercept was administered in both groups if CI-DME with vision loss or high-risk proliferative diabetic retinopathy developed.

 

Aflibercept Sham
CI-DME 16.3% 43.5%
CI-DME with vision loss 4.1% 14.8%
PDR 13.5% 33.2%
Mean change in VA from baseline to 2 years (letters) -0.9 -2.0

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Updated on March 7th, 2022

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