Brinzolamide for the Treatment of Chronic Central Serous Chorioretinopathy

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

Study Overview

• Status: Unknown
• Conditions: Central Serous Chorioretinopathy
• Intervention / Treatment: Drug: Brinzolamide Ophthalmic

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 Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Dinah Zur, MD; Phone Number: +97236973408; Email: dinahzur@gmail.com
• Study Contact Backup: Name: Roy Schwartz, MD; Phone Number: +447392971069; Email: royschwartz@gmail.com

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Iglicki Oftalmologia
    • Contact: Matias Iglicki; Phone Number: +5491148562937; Email: matiasiglicki@gmail.com
• Israel
  • Tel Aviv, Israel
    • Tel Aviv Medical Center
    • Contact: Roy Schwartz, MD; Phone Number: +447392971069; Email: royschwartz@gmail.com
    • Contact: Dinah Zur, MD; Phone Number: +97226973408

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2018
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: October 28, 2017
• First Submitted That Met QC Criteria: May 29, 2018
• First Posted (Actual): May 31, 2018

Study Record Updates

• Last Update Posted (Actual): May 31, 2018
• Last Update Submitted That Met QC Criteria: May 29, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Central Serous Chorioretinopathy; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Carbonic Anhydrase Inhibitors; Brinzolamide
• Other Study ID Numbers: 0647-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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