Brinzolamide for the Treatment of Chronic Central Serous Chorioretinopathy

Study Overview
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Brief Summary
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Examine the efficacy of brinzolamide for the treatment of central serous chorioretinopathy

Detailed Description
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Brinzolamide is a carbonic anhydrase inhibitor. Previously, carbonic anhydrase inhibitors have been shown to be effective for the treatment of macular edema when administered orally, also for central serous chorioretinopathy. However, this treatment carries the risk of severe side effects. The goal of this study is to examine the efficacy of the topical form of treatment of carbonic anhydrase inhibitors in patients with chronic, non-resolving, central serous chorioretinopathy.

Official Title
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Brinzolamide for the Treatment of Chronic Central Serous Chorioretinopathy

Conditions
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Central Serous Chorioretinopathy

Intervention / Treatment
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* Drug: Brinzolamide Ophthalmic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Central serous chorioretinopathy (CSC) affecting the fovea, non-resolving after 4 months of follow-up Optical coherence tomography (OCT) shows foveal subretinal fluid Fluorescein angiography and indocyanine green confirm the diagnosis Exclusion Criteria: Any other ophthalmic condition that may lead to subretinal fluid Choroidal neovascularization Myopia > -6D Previous treatment for CSC in the past 6 months Known allergy to fluorescein or indocyanin green Known allergy for brinzolamide Pregnancy, breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical brinzolamide<br>Brinzolamide ophthalmic, given bd for 3 months | Drug: Brinzolamide Ophthalmic<br>* Topical brinzolamide given bd for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in subretinal fluid (microns) | Change in subretinal fluid as measured by optical coherence tomography | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ETDRS visual acuity (number of letters) | Change in visual acuity from baseline to last follow-up in ETDRS letters | 6 months | 
| Change in central macular thickness (microns) | Change in central macular thickness in microns from baseline to last follow-up | 6 months | 
| Change in choroidal thickness (microns) | Change in choroidal thickness in microns from baseline to last follow-up | 6 months | 
| Time for fluid resolution (days) | Time in days from baseline until fluid resolution, as measured on optical coherence tomography | 6 months | 
| Percentage of patients with fluid resolution | Percentage of patients with fluid resolution by last follow-up as seen on optical coherence tomography, out of all study participants | 6 months | 
| Quality of life assessment (using NEI-VFQ-25 questionnaires) | Quality of life score as assessed by standard questionnaires | 6 months |