Dorzolamide-timolol in Combination With Anti-vascular Endothelial Growth Factor Injections for Wet Age-related Macular Degeneration

• Status: Completed
• Trial end date: 2019-07-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wills Eye
• Collaborator: Mid Atlantic Retina
• Treatments: Bevacizumab; Dorzolamide; Endothelial Growth Factors; Lubricant Eye Drops; Mitogens; Timolol

Criteria

Inclusion Criteria:

1. Active choroidal neovascularization (CNV) due to AMD.

2. 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.

3. Baseline CST ≥ 270 µm on SD-OCT automated retinal thickness map.

4. Injection of the same anti-VEGF agent at each of the two visits immediately preceding study enrollment.

5. Time interval of 5 weeks (± 1 week) between visits for at least two visits immediately preceding study enrollment.

6. Subjects of either gender aged ≥ 45 years.

7. Provide written informed consent

8. Ability to comply with study and follow-up procedures and return for study visits.

Exclusion Criteria:

1. History of uveitis.

2. 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.

3. Any ophthalmic surgery within previous 6 months, including cataract extraction.

4. Any history of vitrectomy or glaucoma surgery (e.g., trabeculectomy, tube shunt).

5. Current prescription eye drop usage (e.g., glaucoma drops, corticosteroid drops, etc.).

6. Any contraindication for topical use of a beta-blocker (e.g., bradycardia, decompensated heart failure, chronic obstructive pulmonary disease, reactive airway disease, asthma, etc.).

7. Any history of sulfonamide allergy.