STUDY DESIGN

Single-center, randomized, controlled trial

DURATION

24 months

STUDY SUBJECTS

<Major inclusion criteria:

• DM1/DM2 with center-involved DME, at least 1 prior macular laser therapy, and no anti-VEGF therapy within the preceding 3 months

Major exclusion criteria:

• Macular ischemia
• PRP in the preceding 3 months, or planned in the subsequent 6 months
• PDR other than NVE < 1 DA without VH

RANDOMIZATION SCHEME AND INTERVENTIONS

Randomized to

• Macular (focal or grid) laser at baseline. Re-evaluation every 4 months with repeat laser per ETDRS guidelines (CSME)
• Intravitreal ranibizumab at baseline and q6w x 3, then reviewed q6wk
  • If central macular thickness (CMT) > 270 µm, ranibizumab given q6w until stable* macular thickness obtained
  • If CMT < 270 µm, ranibizumab only given if CMT become unstable*

* Stable CMT defined as 3 consecutive visits with CMT within 20 µm of the patients thinest recorded CMT

RESULTS

Study population

• 80 randomized, 65 completed the study (higher rate of discontinuation in the laser arm)

Visual acuity end-points

• Mean change in VA: +8.6 letters bevacizumab, -0.5 letters for laser
• Gain of ≥ 15 letters: 32% bevacizumab, 4% laser
• Loss of < 15 letters: 100% bevacizumab, 86% laser

Anatomic outcomes

• Mean reduction in CMT of 146 µm for bevacizumab and 118 µm for laser
• ETDRS severity scores (statistical analysis not provided)
  • Bevacizumab: 31% improved, 66% stable, 3% worse
  • Laser: 20% improved, 68% stable, 12% worse
• No significant differences noted in macular perfusion

CONCLUSIONS

Bevacizumab produced superior visual outcomes at 24 months than macular laser for diabetic macular edema