Brinzolamide for the Treatment of Chronic Central Serous Chorioretinopathy

• Sponsor: Tel-Aviv Sourasky Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03542006
• Collaborator: (none)
• Enrollment: 35
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 10
• Patients Per Site: 17.5
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

Examine the efficacy of brinzolamide for the treatment of central serous chorioretinopathy

Condition or Disease	Intervention/Treatment	Phase
Central Serous Chorioretinopathy	Drug: Brinzolamide Ophthalmic	Phase 2

Detailed Description

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Brinzolamide for the Treatment of Chronic Central Serous Chorioretinopathy
• Anticipated Study Start Date: Jun 1, 2018
• Anticipated Primary Completion Date: Jan 1, 2019
• Anticipated Study Completion Date: Apr 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Topical brinzolamide Brinzolamide ophthalmic, given bd for 3 months	Drug: Brinzolamide Ophthalmic; Topical brinzolamide given bd for 3 months

Outcome Measures

Primary Outcome Measures

1. Change in subretinal fluid (microns) [6 months]

   Change in subretinal fluid as measured by optical coherence tomography

Secondary Outcome Measures

1. Change in ETDRS visual acuity (number of letters) [6 months]

   Change in visual acuity from baseline to last follow-up in ETDRS letters

2. Change in central macular thickness (microns) [6 months]

   Change in central macular thickness in microns from baseline to last follow-up

3. Change in choroidal thickness (microns) [6 months]

   Change in choroidal thickness in microns from baseline to last follow-up

4. Time for fluid resolution (days) [6 months]

   Time in days from baseline until fluid resolution, as measured on optical coherence tomography

5. Percentage of patients with fluid resolution [6 months]

   Percentage of patients with fluid resolution by last follow-up as seen on optical coherence tomography, out of all study participants

6. Quality of life assessment (using NEI-VFQ-25 questionnaires) [6 months]

   Quality of life score as assessed by standard questionnaires

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Iglicki Oftalmologia	Buenos Aires		Argentina
2	Tel Aviv Medical Center	Tel Aviv		Israel

Sponsors and Collaborators

• Tel-Aviv Sourasky Medical Center

Investigators

• Principal Investigator: Dinah Zur, Tel-Aviv Sourasky Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michaella Goldstein, Study Chair, Tel-Aviv Sourasky Medical Center
• ClinicalTrials.gov Identifier: NCT03542006
• Other Study ID Numbers: 0647-17
• First Posted: May 31, 2018
• Last Update Posted: May 31, 2018
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Central Serous Chorioretinopathy; Brinzolamide

Study Results

No Results Posted as of May 31, 2018