Brinzolamide for the Treatment of Chronic Central Serous Chorioretinopathy

Central Serous Chorioretinopathy Clinical Trial

Official title:

Brinzolamide for the Treatment of Chronic Central Serous Chorioretinopathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03542006
• Other study ID #: 0647-17
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2018
• Est. completion date: April 1, 2019

Study information

• Verified date: May 2018
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Dinah Zur, MD
• Phone: +97236973408
• Email: dinahzur[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: April 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy

Intervention

Drug:
• Brinzolamide Ophthalmic
Topical brinzolamide given bd for 3 months

Locations

Country	Name	City	State
Argentina	Iglicki Oftalmologia	Buenos Aires
Israel	Tel Aviv Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Countries where clinical trial is conducted

Argentina,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in subretinal fluid (microns)	Change in subretinal fluid as measured by optical coherence tomography	6 months
Secondary	Change in ETDRS visual acuity (number of letters)	Change in visual acuity from baseline to last follow-up in ETDRS letters	6 months
Secondary	Change in central macular thickness (microns)	Change in central macular thickness in microns from baseline to last follow-up	6 months
Secondary	Change in choroidal thickness (microns)	Change in choroidal thickness in microns from baseline to last follow-up	6 months
Secondary	Time for fluid resolution (days)	Time in days from baseline until fluid resolution, as measured on optical coherence tomography	6 months
Secondary	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
Secondary	Quality of life assessment (using NEI-VFQ-25 questionnaires)	Quality of life score as assessed by standard questionnaires	6 months