Phase 3
N=52
Dorzolamide-timolol in Combination With Anti-vascular Endothelial Growth Factor Injections for Wet Age-related Macular Degeneration
Neovascular Age-related Macular Degeneration · Wet Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT03034772 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Change in Mean Central Subfield Thickness (CST) — -36.6; 1.7 microns — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dorzolamide-timolol (Drug); Artificial tears (Other)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Wills Eye
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Central Subfield Thickness (CST) |
-36.6; 1.7 | 0.04 sig |
| SECONDARY Change in Mean Maximum Subretinal Fluid (SRF) Height |
-49.4; -22.2 | 0.11 |
| SECONDARY Change in Mean Maximum Pigment Epithelial Detachment (PED) Height |
-39.1; 1.1 | 0.01 sig |
| SECONDARY Change in Visual Acuity |
0.031; 0.018 | 0.78 |
| SECONDARY Change in Mean Intraocular Pressure (IOP) |
-1.81; -0.78 | 0.24 |
Summary
A previous pilot study demonstrated that commonly available glaucoma drops (dorzolamide-timolol) might decrease the amount of chronic swelling in patient with wet age-related macular degeneration who have been receiving anti-vascular endothelial growth factor (VEGF) injections. This will be a larger study where subjects are randomly assigned to receive the glaucoma drops or a placebo (artificial tears) in order to confirm whether this previous finding is valid. Subjects will continue to receive the normally scheduled anti-VEGF injections at regular intervals as done prior to enrollment. The only addition to the regimen will be the daily use of eye drops (dorzolamide-timolol or artificial tears) twice daily for the duration of the study. At the end of the study, the swelling in the retina will be compared to the amount before starting the drops to see if there is any difference between the group using dorzolamide-timolol versus artificial tears.
Eligibility Criteria
Inclusion Criteria
- Active choroidal neovascularization (CNV) due to AMD.
- Prior treatment with at least 4 injections of anti-VEGF agents in the past 6 months and persistent intraretinal and/or subretinal fluid on SD-OCT at each visit during this period.
- Baseline CST ≥ 270 µm on SD-OCT automated retinal thickness map.
- Injection of the same anti-VEGF agent at each of the two visits immediately preceding study enrollment.
- Time interval of 5 weeks (± 1 week) between visits for at least two visits immediately preceding study enrollment.
- Subjects of either gender aged ≥ 45 years.
- Provide written informed consent
- Ability to comply with study and follow-up procedures and return for study visits.
Exclusion Criteria
- History of uveitis.
- Presence of intraocular inflammation, significant epiretinal membrane (causing distortion of macular anatomy per investigator discretion), significant vitreomacular traction (per investigator discretion), macular hole, or vitreous hemorrhage.
- Any ophthalmic surgery within previous 6 months, including cataract extraction.
- Any history of vitrectomy or glaucoma surgery (e.g., trabeculectomy, tube shunt).
- Current prescription eye drop usage (e.g., glaucoma drops, corticosteroid drops, etc.).
- Any contraindication for topical use of a beta-blocker (e.g., bradycardia, decompensated heart failure, chronic obstructive pulmonary disease, reactive airway disease, asthma, etc.).
- Any history of sulfonamide allergy.
Data sourced from ClinicalTrials.gov (NCT03034772). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.