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Brinzolamide for the Treatment of Chronic Central Serous Chorioretinopathy

NCT ID: NCT03542006

Last Updated: 2018-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-04-01

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.

Conditions

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Central Serous Chorioretinopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Topical brinzolamide

Brinzolamide ophthalmic, given bd for 3 months

Group Type EXPERIMENTAL

Brinzolamide Ophthalmic

Intervention Type DRUG

Topical brinzolamide given bd for 3 months

Interventions

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Brinzolamide Ophthalmic

Topical brinzolamide given bd for 3 months

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Michaella Goldstein

Study Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dinah Zur

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Locations

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Iglicki Oftalmologia

Buenos Aires, , Argentina

Site Status

Tel Aviv Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Argentina Israel

Central Contacts

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Dinah Zur, MD

Role: CONTACT

Phone: +97236973408

Email: [email protected]

Roy Schwartz, MD

Role: CONTACT

Phone: +447392971069

Email: [email protected]

Facility Contacts

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Matias Iglicki

Role: primary

Dinah Zur, MD

Role: primary

Roy Schwartz, MD

Role: backup

Other Identifiers

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0647-17

Identifier Type: -

Identifier Source: org_study_id