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DRCR.net PROTOCOL V: Initial Management With Aflibercept vs Laser Photocoagulation vs Observation on Vision Loss Among Patients With Diabetic Macular Edema

April 29, 2019

Clinical trial

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.

Baker CW, Glassman AR, Beaulieu WT, Antoszyk AN, Browning DJ, Chalam KV, Grover S, Jampol LM, Jhaveri CD, Melia M, Stockdale CR, Martin DF, Sun JK.

JAMA. 2019 May 21;321(19):1880-1894.
Full text | Metrics.

Main finding: Among eyes with CI-DME and good visual acuity (6/7.5 or better), observation without treatment (unless VA worsens) may be considered.Purpose: To compare vision loss at 2 years among eyes initially managed with aflibercept, laser photocoagulation, or observation

 

  • Purpose: To compare vision loss at 2 years among eyes initially managed with aflibercept, laser photocoagulation, or observation.
  • Study type: Randomized controlled trial
  • Condition: Diabetic Macular Edema

Participants: Type 1 or 2 DM, Ci-DME , VA 20/25 (6/7.5) or better

 

  • n=702

 

Intervention:

 

Groups:

 

  • Group 1: Intravitreal aflibercept 2.0mg
  • Group 2: Focal/grid laser
  • Group 3: Observation

There was no significant difference in vision loss at 2 years between initial management with aflibercept or with focal/grid laser or observation and given aflibercept only if visual acuity worsened.

Outcome Aflibercept Laser Observation
Proportion of eyes with at least 5-letter VA decrease 16% 17% 19%

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