Brinzolamide for the Treatment of Chronic Central Serous... | NCT03542006

Studies
Brinzolamide for the Treatment of Chronic Central Serous Chorioretinopathy

NCT03542006

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

May 31, 2018Actual

Enrollment

35Estimated

Phase

Phase 2

Conditions

Central Serous Chorioretinopathy

Interventions

Brinzolamide Ophthalmic

Countries

Argentina
Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2018Estimated

Primary Completion Date

Jan 1, 2019Estimated

Completion Date

Apr 1, 2019Estimated

First Submitted Date

Oct 28, 2017

First Submission Date that Met QC Criteria

May 29, 2018

First Posted Date

May 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2018

Last Update Posted Date

May 31, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michaella Goldstein, Study Chair, Tel-Aviv Sourasky Medical CenterPrincipal Investigator

Lead Sponsor

Tel-Aviv Sourasky Medical CenterOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Topical brinzolamide	Experimental	Brinzolamide ophthalmic, given bd for 3 months	Drug: Brinzolamide Ophthalmic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brinzolamide Ophthalmic	Drug	Topical brinzolamide given bd for 3 months	Topical brinzolamide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in subretinal fluid (microns)	Change in subretinal fluid as measured by optical coherence tomography	6 months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dinah Zur, MD	Contact	+97236973408		dinahzur@gmail.com
Roy Schwartz, MD	Contact	+447392971069		royschwartz@gmail.com

Overall Officials

Name	Affiliation	Role
Dinah Zur	Tel-Aviv Sourasky Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Iglicki Oftalmologia		Buenos Aires			Argentina

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D056833	Central Serous Chorioretinopathy

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided