Impact of Cataract Surgery during Treatment with Ranibizumab in Patients with Diabetic Macular Edema

Abstract

Purpose: To determine how best-corrected visual acuity (BCVA) was affected by cataract surgery in patients with diabetic macular edema (DME) who were treated with ranibizumab during the RIDE/RISE phase III trials.

Design: Post hoc analysis of data from RIDE and RISE, 2 phase III, parallel, randomized, multicenter, double-masked trials (clinicaltrials.gov identifiers, NCT00473382 and NCT00473330).

Participants: Patients with DME (N = 759) who were randomized 1:1:1 to monthly intravitreal ranibizumab 0.3 mg or 0.5 mg, or sham injections for 24 months.

Methods: Patient records in the electronic RIDE/RISE study database were examined for cataract surgeries using the terms "cataract extraction," "cataract removal," "cataract surgery," "lens implant," and "lensectomy." The last study visit immediately before cataract surgery served as the redefined baseline to examine subsequent BCVA changes. The t test was performed to compare times to cataract surgery for the sham and pooled ranibizumab groups.

Main outcome measures: Mean change in BCVA from redefined baseline to 1, 2, and 3 months (±15 days) after surgery.

Results: Among study eyes that underwent cataract surgery, mean BCVA at original study baseline was 54.6 letters in the pooled ranibizumab arms and 56.6 letters in the sham arm (approximate Snellen equivalent 20/80). At the redefined presurgery baseline, mean BCVA was 54.2 letters for the pooled ranibizumab group and 46.6 letters for the sham-treated study eyes. Compared with the redefined baseline, at 1 month after surgery, mean BCVA changes were +10.6 letters for ranibizumab-treated patients and +10.3 letters for sham-treated patients. Compared with the original baseline, at 1 month after surgery, on average, ranibizumab-treated study eyes experienced mean BCVA improvement (+11.3 letters), whereas sham-treated eyes (-0.5 letters) and fellow eyes (+1.8 and +1.7 letters for ranibizumab and sham, respectively) had a mean BCVA similar to the original baseline.

Conclusions: In patients undergoing ranibizumab treatment for DME and who had cataract surgery, an average of 2 lines of vision were gained from the last visit before surgery to 1 month after surgery.