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 :
Completed
First Posted : January 27, 2017
Results First Posted : June 19, 2020
Last Update Posted : June 19, 2020
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Condition or disease | Intervention/treatment | Phase |
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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 |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Masking Description: | Single-blind |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
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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.
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Drug: Dorzolamide-timolol
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.
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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.

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Ages Eligible for Study: | 45 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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 |
Documents provided by Jason Hsu, MD, Wills Eye:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Jason Hsu, MD, Co-director of Retina Research, Wills Eye |
ClinicalTrials.gov Identifier: | NCT03034772 |
Other Study ID Numbers: |
16-596 |
First Posted: | January 27, 2017 Key Record Dates |
Results First Posted: | June 19, 2020 |
Last Update Posted: | June 19, 2020 |
Last Verified: | June 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
neovascular wet age-related |
macular degeneration dorzolamide timolol |
Macular Degeneration Wet Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Timolol Dorzolamide Lubricant Eye Drops Adrenergic beta-Antagonists Adrenergic Antagonists |
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