dorzolamide-timolol-combination and Macular-Edema

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 compare the efficacy of fixed combinations of dorzolamide-timolol (FCDT) and brimonidine-timolol (FCBT) in patients with intraocular pressure (IOP) elevations after intravitreal triamcinolone acetonide (IVTA) injections.. This was a prospective, randomized, open-label study. Patients who received IVTA injections due to diffuse diabetic macular edema and who had an IOP of 24 mm Hg or higher after IVTA treatment were included. They were randomized to receive either FCBT or FCDT twice daily. Follow-up visits were scheduled on week 4 and 12 weeks after starting the study medication. At all follow-up visits, IOP was measured with Goldmann applanation tonometry. The primary outcome measure was mean IOP, the secondary outcome was reduction in mean IOP at 4 and 12 weeks compared with postinjection values.. Sixty patients were randomized in 1:1 ratio. The FCBT and FCDT groups were similar in terms of age, sex, and preinjection IOP (P>0.05 for all). Mean postinjection IOP was 31.95±7.39 and 29.83±5.17 mm Hg in FCBT and FCDT groups, respectively (P=0.239). After 4 weeks, mean IOP was 17.05±3.61 mm Hg in FCBT and 18.93±3.30 mm Hg in FCDT groups (P=0.063). After 12 weeks, mean IOP in the FCBT and FCDT study groups was 16.35±2.70 and 18.43±2.82 mm Hg, respectively (P=0.012). Both fixed combinations significantly reduced IOP in comparison with the postinjection values (P<0.05). Mean reduction in IOP after 4 weeks were 14.90±7.28 mm Hg in FCBT and 10.90±4.83 mm Hg in FCDT groups (P=0.024); after 12 weeks, these values were 15.60±7.77 and 11.40±5.89 mm Hg in FCBT and FCDT groups, respectively (P=0.035).. Both FCBT and FCDT are effective in controlling IOP elevations after IVTA injections. The results of this study suggest that FCBT is superior to FCDT in reducing IOP and provides better IOP control after IVTA injections.

Topics: Aged; Antihypertensive Agents; Brimonidine Tartrate; Diabetic Retinopathy; Drug Combinations; Female; Glucocorticoids; Humans; Intraocular Pressure; Intravitreal Injections; Macular Edema; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Quinoxalines; Sulfonamides; Thiophenes; Timolol; Tonometry, Ocular; Triamcinolone Acetonide

To evaluate topical dorzolamide hydrochloride-timolol maleate as an adjunct therapy to intravitreous anti-vascular endothelial growth factor injections in eyes with retinal vein occlusion resistant to treatment.. Retinal vein occlusion patients with a history of persistent macular edema, despite fixed-interval intravitreous anti-vascular endothelial growth factor injections, were enrolled between April 4, 2016, and June 4, 2017. On enrollment, patients were instructed to administer one drop of topical dorzolamide-timolol twice daily for the duration of the study. They were maintained on the same anti-vascular endothelial growth factor drug and same interval between injections as preenrollment for the subsequent two visits. Primary outcome measures were change in central foveal thickness, central subfield thickness, and thickest macular cut at the final study visit.. Eight patients (8 eyes) were eligible for enrollment and completed the study. There was a significant decrease in central foveal thickness (P = 0.02), central subfield thickness (P = 0.03), and thickest macular cut (P = 0.01) between the enrollment visit and the final visit. There was a decrease in mean (±SD) logarithm of the minimal angle of resolution from 0.52 (±0.35) (20/66, Snellen equivalent) at the enrollment visit to 0.41 (±0.35) (20/51, Snellen equivalent) at the final visit (P = 0.08).. Topical dorzolamide-timolol may have a beneficial anatomical and functional effect in eyes with macular edema secondary to retinal vein occlusion resistant to treatment.

Topics: Administration, Ophthalmic; Aged; Aged, 80 and over; Angiogenesis Inhibitors; Bevacizumab; Drug Combinations; Drug Therapy, Combination; Female; Fovea Centralis; Humans; Intraocular Pressure; Intravitreal Injections; Macular Edema; Male; Middle Aged; Ophthalmic Solutions; Pilot Projects; Ranibizumab; Receptors, Vascular Endothelial Growth Factor; Recombinant Fusion Proteins; Retinal Vein Occlusion; Sulfonamides; Thiophenes; Timolol; Tomography, Optical Coherence; Vascular Endothelial Growth Factor A; Visual Acuity