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

Phase 2

Completed

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

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Dorzolamide-timolol	Dorzolamide-timolol	* On enrollment, eligible patients will have visual acuity testing, intraocular pressure, dilated fundoscopic examination, SD-OCT scan and will then receive the same intravitreal pharmacologic agent administered at prior visit. * Subsequent follow-up visits will be at an identical interval to pre-enrollment visit intervals (4, 5, or 6 week intervals) for the study duration. * Each subsequent visit will consist of visual acuity testing, intraocular pressure, dilated fundoscopic examination, SD-OCT scan, and intravitreal injection of same pharmacologic agent as prior visits * At study conclusion, mean central macular thickness, maximum subretinal fluid height, and maximum pigment epithelial detachment height will be measured over the study period for all patients

Primary Outcome Measures

Name	Time	Method
Mean Central Subfield Thickness (CST)	3 visits (8-12 weeks)	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

Secondary Outcome Measures

Name	Time	Method
Visual Acuity	3 visits (8-12 weeks)	LogMAR Visual acuity on enrollment and final visit
Maximum Subretinal Fluid Height	3 visits (8-12 weeks)	Measurement based on SD-OCT
Maximum Pigment Epithelial Detachment Height	3 visits (8-12 weeks)	Measurement based on SD-OCT