dorzolamide-timolol-combination and Wet-Macular-Degeneration

Some eyes with neovascular age-related macular degeneration (AMD) have persistent exudation despite frequent intravitreal anti-vascular endothelial growth factor (VEGF) injections. Adjuvant therapies that further reduce edema may improve vision outcomes.. To compare the short-term effect of topical dorzolamide-timolol vs placebo in eyes with neovascular AMD that have persistent exudation following intravitreal anti-VEGF injections.. Randomized placebo-controlled clinical trial with enrollment from March 1, 2017, through October 30, 2018. Multicenter trial at 4 clinical sites in the United States. Sixty-three patients with neovascular AMD who had persistent exudation despite intravitreal anti-VEGF injections at 4-week, 5-week, or 6-week intervals.. Patients were randomized to use dorzolamide-timolol or artificial tears for the study duration. They continued to receive the same anti-VEGF drug at the same interval as the 2 visits before enrollment for 3 additional study visits.. The primary outcome measure was change in mean central subfield thickness on optical coherence tomography from baseline to visit 3 (approximately 3 months). Secondary measures included change in mean maximum subretinal fluid height, mean maximum pigment epithelial detachment height, and mean visual acuity (VA).. This trial included 52 patients. All 27 patients (100%) assigned to dorzolamide-timolol and 23 of 25 (92%) assigned to placebo were analyzed for the primary outcome. Mean (SD) age was 78.4 (7) years, and 34 of 50 patients (68%) were women. Mean (SD) injections were 20.5 (14) (range, 4-58) before enrollment. Mean (SD) baseline logMAR VA was 0.361 (0.26) (approximate Snellen equivalent, 20/50). Comparing the dorzolamide-timolol with placebo group from baseline to visit 3, mean (SD) change in central subfield thickness (primary outcome) was -36.6 (54) μm vs 1.7 (52.3) μm (difference, 30.8; 95% CI, 0.3-61.3; P = .04); secondary outcomes: maximum PED height was -39.1 (65) μm vs 1.1 (16) μm (difference, 39.6; 95% CI, 9.6-69.6; P = .01) and change in VA from baseline to visit 3 was -2.3 (5) vs 0.3 (1) letters (difference, 2.6 letters; 95% CI, -1.9 to 7.1 letters; P = .78).. These findings suggest use of dorzolamide-timolol in patients with neovascular AMD with persistent exudation resulted in anatomic but not visual acuity improvements compared with placebo at approximately 3 months. Additional clinical trials with longer follow-up and larger sample sizes presumably would be needed to determine the role, if any, of dorzolamide-timolol in neovascular AMD.. ClinicalTrials.gov Identifier: NCT03034772.

Topics: Administration, Ophthalmic; Aged; Aged, 80 and over; Angiogenesis Inhibitors; Chemotherapy, Adjuvant; Choroidal Neovascularization; Drug Combinations; Exudates and Transudates; Female; Humans; Intraocular Pressure; Intravitreal Injections; Macular Edema; Male; Ophthalmic Solutions; Placebos; Single-Blind Method; Sulfonamides; Thiophenes; Timolol; Tomography, Optical Coherence; Visual Acuity; Wet Macular Degeneration

To evaluate the efficacy of adjuvant topical dorzolamide-timolol in patients with neovascular age-related macular degeneration unresponsive to anti-vascular endothelial growth factor therapy.. This retrospective, interventional study included 15 patients with neovascular age-related macular degeneration refractory to anti-vascular endothelial growth factor. Patients used topical dorzolamide-timolol twice daily in the neovascular age-related macular degeneration eye and received anti-vascular endothelial growth factor therapy at each visit, with the same fixed interval and agent as before the addition of dorzolamide-timolol. Central macular thickness, maximal subretinal fluid height, and maximal pigment epithelial detachment height were measured at baseline and every visit.. The mean follow-up period was 17.2 ± 5.5 weeks. The mean central macular thickness decreased from 383.5 μm at baseline to 298.3 μm at the final visit (P = 0.041). The mean maximal subretinal fluid height decreased from 105.0 μm at baseline to 58.3 μm at the final visit (P = 0.021). Complete resolution of subretinal fluid was observed in 3 of 11 subretinal fluid-type eyes. There was no significant change in the maximal pigment epithelial detachment height. The mean logarithm of the minimum angle of resolution visual acuity decreased from 0.61 (20/81 Snellen) at baseline to 0.66 (20/91 Snellen) at final visit, which was not significant (P = 0.314). The mean intraocular pressure decreased significantly from 14.9 mmHg at baseline to 12.3 mmHg at the final visit (P = 0.005).. The use of adjuvant topical dorzolamide-timolol was effective in decreasing central macular thickness and subretinal fluid in patients with neovascular age-related macular degeneration refractory to continual fixed-interval intravitreal anti-vascular endothelial growth factor therapy, but did not result in functional improvement in this short-term study.

Topics: Administration, Topical; Aged; Angiogenesis Inhibitors; Bevacizumab; Drug Combinations; Female; Follow-Up Studies; Humans; Intravitreal Injections; Macula Lutea; Macular Degeneration; Male; Ophthalmic Solutions; Ranibizumab; Retrospective Studies; Sulfonamides; Thiophenes; Timolol; Tomography, Optical Coherence; Treatment Outcome; Vascular Endothelial Growth Factor A; Visual Acuity; Wet Macular Degeneration