Effect of Adjuvant Topical Dorzolamide-Timolol versus Placebo in Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial

Abstract

Purpose : To compare the effect of topical dorzolamide-timolol versus placebo in eyes with neovascular age-related macular degeneration (nAMD) that are suboptimal responders to intravitreal anti-VEGF injections.

Methods : This prospective, multicenter randomized clinical trial enrolled patients with nAMD and persistent macular edema despite frequent fixed-interval intravitreal anti-VEGF therapy. Sixty-two patients with nAMD who had persistent exudation despite intravitreal anti-VEGF injections at 4-, 5-, or 6-week intervals were screened for eligibility. Patients were randomized to use dorzolamide-timolol or artificial tears twice daily for the study duration. After enrollment, they received the same anti-VEGF drug at the same interval as the 2 visits before enrollment for three additional study visits. The primary outcome measure was change in mean central subfield thickness (CST) on optical coherence tomography (OCT) from baseline to final visit. Secondary measures included change in mean maximum subretinal fluid (SRF) height, mean maximum pigment epithelial detachment (PED) height, and mean VA from baseline to final visit.

Results : Fifty patients completed the study with 27 in the dorzolamide-timolol group. Mean age was 78.4 years (range, 65–94) with 20.5 mean injections (range, 4–58) prior to enrollment. At enrollment, there were no differences between the dorzolamide-timolol and control groups in baseline demographic or OCT parameters (Table 1). Comparing the dorzolamide-timolol to the placebo group from baseline to final visit, mean (standard error) change in CST was -36.6 (11) μm vs. +1.7 (11) μm (P=0.023); maximum PED height was -31.5 (11) μm vs. +1.1 (4) μm (P=0.001); maximum SRF height was -49.4 (11) μm vs. -22.2 (12) μm (P=0.039); and logMAR VA was 0.031 (0.03) vs. 0.018 (0.03) (P=0.658) (Figure 1).

Conclusions : Topical dorzolamide-timolol in eyes with nAMD that have persistent exudation despite frequent anti-VEGF injections resulted in anatomic improvements on OCT compared to placebo. No significant change in visual acuity was detected.

This is a 2020 ARVO Annual Meeting abstract.

 

Table 1. Baseline Characteristics

 

Figure 1. Changes in A) central subfield thickness, B) maximum pigment epithelial detachment height, C) maximum subretinal fluid height, D) central subfoveal fluid height, E) central foveal thickness, and F) mean visual acuity at each visit. Dorzolamide-timolol (black); placebo (gray)