CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 52 enrolled
Drug / intervention
Dorzolamide-timolol +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03034772
NCT03034772Phase 3Completed

A Randomized Controlled Trial Comparing the Effect of Topical Dorzolamide-Timolol Versus Placebo Combined With Intravitreal Anti-Vascular Endothelial Growth Factor (VEGF) Injections in Patients With Neovascular Age-Related Macular Degeneration Who Are Incomplete Anti-VEGF Responders

Wills Eye·interventional·Posted Jan 27, 2017·Updated Jun 19, 2020

In Brief

A Phase 3 clinical trial evaluating Dorzolamide-timolol and Artificial tears for Neovascular Age-related Macular Degeneration and Wet Macular Degeneration. Completed, enrolled 52 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsMid Atlantic Retina

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 27, 2017
Enrollment StartFeb 8, 2017
Primary CompletionFeb 8, 2019
Study CompletionJul 5, 2019
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 9.4 years ago

Interventions

Dorzolamide-timololdrug

Topical eye drop (active comparator) used twice daily for study duration

Artificial tearsother

Topical eye drop (placebo comparator) used twice daily for study duration