Dorzolamide-timolol Drops With Injections to Treat AMD, RVO or DME.

Phase 2CompletedNCT02571972

Wills Eye14 enrolled

Overview

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.

Intravitreal anti-vascular endothelial growth factor (VEGF) agents, including bevacizumab, ranibizumab, and aflibercept, have become the gold standard treatment for neovascular age-related macular degeneration (AMD). Various treatment modalities using these agents have been proposed, including monthly, pro re nata, and treat-and-extend philosophies. Despite frequent and consistent treatment with anti-VEGF therapy, there is a subset of patients who are incomplete or non-responders and have persistent evidence of exudation on spectral-domain optical coherence tomography (SD-OCT), including subretinal fluid (SRF) and/or intraretinal edema. While clearance of intravitreal anti-VEGF drugs is not completely understood, some studies have suggested that outflow through the anterior chamber may contribute. We hypothesized that by decreasing aqueous production, outflow may also be reduced which could delay the clearance of intravitreal drugs. As a result, we chose topical dorzolamide-timolol since it is a potent aqueous suppressant and is readily available due to its common use in the treatment of glaucoma. The current study aimed to evaluate the efficacy of topical dorzolamide-timolol on anatomic and visual outcomes in anti-VEGF non-responders with neovascular AMD. Significance: The results of this study will help delineate whether topical aqueous suppression may be useful as adjuvant therapy in patients receiving chronic intravitreal anti-VEGF injections.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Wet Macular Degeneration Age-related Macular Degeneration Diabetic Macular Edema Retinal Vein Occlusion

Interventions

Dorzolamide-timololDRUG

On enrollment, eligible patients will be started on topical dorzolamide-timolol in the study eye twice daily for the study duration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient of Wills Eye Hospital Retina Service and/or Mid Atlantic Retina. 2. Volunteer patients age 18 years and older. 3. Healthy enough to participate in the study. 4. Willing and able to consent to participation in the study. 5. Diagnosis of wet age-related macular degeneration 6. 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 7. Injection of the same anti-VEGF agent for at least two visits prior to study enrollment 8. Fixed interval between at least two visits prior to study enrollment Exclusion Criteria: 1. History of uveitis 2. Any ophthalmic surgery within previous 6 months, including cataract extraction. 3. Any history of vitrectomy 4. History of any glaucoma drop usage or prior glaucoma surgery 5. Systemic diuretic or corticosteroid usage 6. Any contraindication (bradycardia, decompensated heart failure, or reactive 7. airway disease) for topical use of a beta-blocker 8. Any history of sulfonamide allergy \-

Locations (1)

Wills Eye Hospital / Mid Atlantic Retina

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Mean Central Subfield Thickness (CST)

Mean central subfield thickness (CST) on spectral domain optical coherence tomography (SD-OCT) on 1 visit prior to enrollment and all visits subsequent to study enrollment

Time frame: 3 visits (8-12 weeks)

Secondary Outcomes

Visual Acuity

LogMAR Visual acuity on enrollment and final visit

Time frame: 3 visits (8-12 weeks)

Maximum Subretinal Fluid Height

Measurement based on SD-OCT

Time frame: 3 visits (8-12 weeks)

Maximum Pigment Epithelial Detachment Height

Measurement based on SD-OCT

Time frame: 3 visits (8-12 weeks)

Data from ClinicalTrials.gov

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