Dorzolamide-timolol in Combination With Anti-vascular Endothelial Growth Factor Injections for Wet Age-related Macular Degeneration (DAWN)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03034772|
Recruitment Status : Completed
First Posted : January 27, 2017
Results First Posted : June 19, 2020
Last Update Posted : June 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Neovascular Age-related Macular Degeneration Wet Macular Degeneration||Drug: Dorzolamide-timolol Other: Artificial tears||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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|
|Actual Study Start Date :||February 8, 2017|
|Actual Primary Completion Date :||February 8, 2019|
|Actual Study Completion Date :||July 5, 2019|
Active Comparator: Dorzolamide-timolol
Topical dorzolamide-timolol twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.
Topical eye drop (active comparator) used twice daily for study duration
Other Name: Cosopt
Placebo Comparator: Artificial tears
Topical artificial tears twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.
Other: Artificial tears
Topical eye drop (placebo comparator) used twice daily for study duration
- Change in Mean Central Subfield Thickness (CST) [ Time Frame: Baseline and 18 weeks ]Change in mean CST on spectral domain optical coherence tomography from baseline to the final visit
- Change in Mean Maximum Subretinal Fluid (SRF) Height [ Time Frame: Baseline and 18 weeks ]Change in mean maximum SRF height on spectral domain optical coherence tomography from baseline to final visit.
- Change in Mean Maximum Pigment Epithelial Detachment (PED) Height [ Time Frame: Baseline and 18 weeks ]Change in mean maximum PED height on spectral domain optical coherence tomography from baseline to final visit.
- Change in Visual Acuity [ Time Frame: Baseline and 18 weeks ]Change in mean best available visual acuity from baseline to final visit.
- Change in Mean Intraocular Pressure (IOP) [ Time Frame: Baseline and 18 weeks ]Change in mean IOP from baseline to final visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034772
|United States, California|
|Palo Alto Medical Foundation|
|Palo Alto, California, United States, 94301|
|United States, Massachusetts|
|Ophthalmic Consultants of Boston|
|Boston, Massachusetts, United States, 02114|
|United States, Michigan|
|Associated Retinal Consultants|
|Royal Oak, Michigan, United States, 48073|
|United States, Pennsylvania|
|Mid Atlantic Retina- Wills Eye Institute|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Texas|
|Retina Consultants of Houston|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jason Hsu, MD||Wills Eye|