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Brinzolamide for the Treatment of Chronic Central Serous Chorioretinopathy

Primary Purpose

Central Serous Chorioretinopathy

Status

Unknown status

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Brinzolamide Ophthalmic

About this trial

This is an interventional treatment trial for Central Serous Chorioretinopathy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Iglicki Oftalmologia
Tel Aviv Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Topical brinzolamide

Arm Description

Brinzolamide ophthalmic, given bd for 3 months

Outcomes

Primary Outcome Measures

Change in subretinal fluid (microns)

Change in subretinal fluid as measured by optical coherence tomography

Secondary Outcome Measures

Change in ETDRS visual acuity (number of letters)

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

Change in central macular thickness (microns)

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

Change in choroidal thickness (microns)

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

Time for fluid resolution (days)

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

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

Quality of life assessment (using NEI-VFQ-25 questionnaires)

Quality of life score as assessed by standard questionnaires

Full Information

NCT ID

NCT03542006

First Posted

October 28, 2017

Last Updated

May 29, 2018

Sponsor

Tel-Aviv Sourasky Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03542006

Brief Title

Brinzolamide for the Treatment of Chronic Central Serous Chorioretinopathy

Official Title

Brinzolamide for the Treatment of Chronic Central Serous Chorioretinopathy

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2018 (Anticipated)

Primary Completion Date

January 1, 2019 (Anticipated)

Study Completion Date

April 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tel-Aviv Sourasky Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Central Serous Chorioretinopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Topical brinzolamide

Arm Type

Experimental

Arm Description

Brinzolamide ophthalmic, given bd for 3 months

Intervention Type

Drug

Intervention Name(s)

Brinzolamide Ophthalmic

Intervention Description

Topical brinzolamide given bd for 3 months

Primary Outcome Measure Information:

Title

Change in subretinal fluid (microns)

Description

Change in subretinal fluid as measured by optical coherence tomography

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Change in ETDRS visual acuity (number of letters)

Description

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

Time Frame

6 months

Title

Change in central macular thickness (microns)

Description

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

Time Frame

6 months

Title

Change in choroidal thickness (microns)

Description

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

Time Frame

6 months

Title

Time for fluid resolution (days)

Description

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

Time Frame

6 months

Title

Percentage of patients with fluid resolution

Description

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

Time Frame

6 months

Title

Quality of life assessment (using NEI-VFQ-25 questionnaires)

Description

Quality of life score as assessed by standard questionnaires

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dinah Zur, MD

Phone

+97236973408

dinahzur@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Roy Schwartz, MD

Phone

+447392971069

royschwartz@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dinah Zur

Organizational Affiliation

Tel-Aviv Sourasky Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Iglicki Oftalmologia

City

Buenos Aires

Country

Argentina

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Matias Iglicki

Phone

+5491148562937

matiasiglicki@gmail.com

Facility Name

Tel Aviv Medical Center

City

Tel Aviv

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dinah Zur, MD

Phone

+97226973408

First Name & Middle Initial & Last Name & Degree

Roy Schwartz, MD

Phone

+447392971069

royschwartz@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Brinzolamide for the Treatment of Chronic Central Serous Chorioretinopathy

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