Dorzolamide-timolol in Combination With Anti-vascular Endothelial Growth Factor Injections for Wet Age-related Macular Degeneration (DAWN)
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|ClinicalTrials.gov Identifier: NCT03034772|
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : April 19, 2018
|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)|
|Estimated Enrollment :||50 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|
|Estimated Primary Completion Date :||November 28, 2018|
|Estimated Study Completion Date :||November 28, 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
- Mean central subfield thickness (CST) on spectral domain optical coherence tomography [ Time Frame: 18 weeks ]Change in mean central subfield thickness (CST) on spectral domain optical coherence tomography (SD-OCT) from baseline to the final visit
- Mean maximum subretinal fluid (SRF) height on spectral domain optical coherence tomography [ Time Frame: 18 weeks ]Change in mean maximum SRF height on spectral domain optical coherence tomography from baseline to final visit.
- Mean maximum pigment epithelial detachment (PED) height on spectral domain optical coherence tomography [ Time Frame: 18 weeks ]Change in mean maximum PED height on spectral domain optical coherence tomography from baseline to final visit.
- Visual acuity [ Time Frame: 18 weeks ]Change in mean best available visual acuity from baseline to final visit.
- Mean intraocular pressure (IOP) [ Time Frame: 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
|Contact: Michele Formosoemail@example.com|
|Contact: Kelly Diiennofirstname.lastname@example.org|
|United States, California|
|Palo Alto Medical Foundation||Recruiting|
|Palo Alto, California, United States, 94301|
|Contact: Ehsan Rahimy, MD 650-853-2974|
|United States, Massachusetts|
|Ophthalmic Consultants of Boston||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Chirag Shah, MD 800-635-0489|
|United States, Michigan|
|Associated Retinal Consultants||Recruiting|
|Royal Oak, Michigan, United States, 48073|
|Contact: Jeremy Wolfe, MD 248-288-2280|
|United States, Pennsylvania|
|Mid Atlantic Retina- Wills Eye Institute||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Michele Formoso 215-928-3092 email@example.com|
|Principal Investigator: Jason Hsu, MD|
|United States, Texas|
|Retina Consultants of Houston||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Eric Chen, MD 800-833-5921|
|Principal Investigator:||Jason Hsu, MD||Wills Eye|