Effect of Vitreomacular Adhesion on Treatment Outcomes in the Ranibizumab for Edema of the mAcula in Diabetes-3 (READ-3) Study –Month 24 Results

Abstract

Purpose : To evaluate the role of vitreomacular adhesion (VMA) in determining long-term visual and anatomic outcomes in patients with diabetic macular edema (DME).

Methods : In the READ-3 study, patients with DME received monthly intravitreal injections of either 0.5 or 2.0 mg of ranibizumab for 6 treatments followed by as-needed injections until month 24. OCT images from patients who completed the month-24 visit of the study were analyzed at the baseline visit to identify the presence (VMA+) or absence (VMA-) of VMA. Patients with any degree of vitreomacular traction (VMT) were excluded from the analysis. Two independent graders graded all images. VMA was classified by size of adhesion into either focal (<1500 µm) or broad (≥1500 µm). Main outcome measures were mean change in best corrected visual acuity (BCVA) and central retinal thickness (CRT) at month 24. Student t-test was performed; statistical significance was set at p<0.05.

Results : 152 eyes (152 patients) were randomized in the READ-3 study. 95 eyes (95 patients) were found to be eligible for the study based on study criteria. 57 eyes did not meet study criteria and were excluded from the study; 17 patients had ungradable images, 39 patients did not complete the month 24 visit and 1 patient had VMT. At baseline, 20 patients were classified as VMA (+) and 75 patients were classified as VMA (-). The distribution of the two doses of RBZ (0.5mg and 2.0mg) in the two groups was similar. At month 24, the VMA (+) group showed a mean improvement of 13.45 ± 9.80 letters, whereas the VMA (-) group showed a mean improvement of 8.07 ± 9.58 letters. The difference between the two groups was statistically significant (p= 0.039). Mean improvement in CRT was 173.42 ± 153.68 µm and 185.85 ± 140.88 µm in the VMA (+) and VMA (-) groups, respectively (p=0.548).

Conclusions : Diabetic macular edema patients with VMA have a greater potential for improvement in visual outcomes with long-term anti-vascular endothelial growth factor therapy. Therefore, the presence of VMA should not preclude patients with DME from receiving treatment.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.