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

Abstract

 

Purpose

 

The role of vitreomacular adhesion (VMA) in visual and anatomic outcomes has not been explored previously in patients with diabetic macular edema (DME). In this retrospective study, data from patients enrolled in the READ-3 study was analyzed to evaluate the association of VMA with best corrected visual acuity (BCVA) and central retinal thickness (CRT).

 

Methods

 

In the READ-3 study, patients with DME received monthly IVT injections of either 0.5 or 2.0mg ranibizumab (RBZ). Spectral domain optical coherence tomography (SD-OCT) images (Heidelberg Spectralis®) from patients that completed the M6 primary end point of the study were analyzed at baseline visit (BL) to identify the presence (VMA+) or absence (VMA-) of VMA. Patients with any degree of vitreomacular traction, as defined in published literature, were excluded from analysis. All images were graded by two independent graders. VMA was classified by size of adhesion into either focal (<1500µm) or broad (≥1500µm). Main outcome measures were mean change in BCVA and CRT at M6. 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. 124 eyes (124 patients) were found to be eligible for the study. At BL, 26 patients were classified as VMA(+) and 98 patients were classified as VMA(-). BL characteristics are shown in Table. The distribution of the two doses of RBZ (0.5mg and 2.0mg) between the two groups was equal. At M 6, the VMA(+) group showed a mean improvement of 11.31±6.67 letters, whereas the VMA(-) group showed a mean improvement of 6.86±7.58 letters. The difference between the two groups was statistically significant (p=0.007). Mean improvement in CRT was 173.81±132.31µm and 161.84±131.34 µm in the VMA(+) and VMA(-) groups respectively (p=0.681).<br /> At M6, among the 26 VMA(+) eyes (at BL), 12 eyes showed either complete (9) or partial (3) resolution; 12 eyes showed no change in VMA status; 2 eyes were not gradable and were excluded. Changes in VMA status in the VMA(+) group did not lead to statistically significant differences in VA and CRT at M6.

 

Conclusions

 

Patients with DME and VMA(+) may achieve higher visual gain with anti-VEGF therapy than those who are VMA(-). The analyses also suggest that VMA status should not be a determining factor in considering anti-VEGF therapy for eyes with DME.  

 

Table - Baseline Characteristics