Phase 2
N=14
Dorzolamide-timolol Drops With Injections to Treat AMD, RVO or DME.
Wet Macular Degeneration · Age-related Macular Degeneration · Diabetic Macular Edema · Retinal Vein Occlusion
Bottom Line
View on ClinicalTrials.gov: NCT02571972 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Mean Central Subfield Thickness (CST) — 422.9; 419.7; 364.5; 346.7 microns
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dorzolamide-timolol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wills Eye
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Central Subfield Thickness (CST) |
422.9; 419.7; 364.5; 346.7; 326.9; 334.1 | — |
| SECONDARY Visual Acuity |
0.54; 0.48 | — |
| SECONDARY Maximum Subretinal Fluid Height |
111.5; 126.6; 77.9; 62.0; 56.5; 49.5 | — |
| SECONDARY Maximum Pigment Epithelial Detachment Height |
275.4; 277.4; 258.9; 227.8; 275.4; 239.9 | — |
Summary
This study seeks to evaluate the effect of topical aqueous suppression on the anatomic and functional response to intravitreal anti-vascular endothelial growth factor (VEGF) injections in non-responders with wet age-related macular degeneration.
Eligibility Criteria
Inclusion Criteria
- Patient of Wills Eye Hospital Retina Service and/or Mid Atlantic Retina.
- Volunteer patients age 18 years and older.
- Healthy enough to participate in the study.
- Willing and able to consent to participation in the study.
- Diagnosis of wet age-related macular degeneration
- 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
- Injection of the same anti-VEGF agent for at least two visits prior to study enrollment
- Fixed interval between at least two visits prior to study enrollment
Exclusion Criteria
- History of uveitis
- Any ophthalmic surgery within previous 6 months, including cataract extraction.
- Any history of vitrectomy
- History of any glaucoma drop usage or prior glaucoma surgery
- Systemic diuretic or corticosteroid usage
- Any contraindication (bradycardia, decompensated heart failure, or reactive
- airway disease) for topical use of a beta-blocker
- Any history of sulfonamide allergy
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Data sourced from ClinicalTrials.gov (NCT02571972). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.