NCT03542006

Brief Summary

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

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2018

Shorter than P25 for phase_2

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2017

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 31, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

May 31, 2018

Status Verified

May 1, 2018

Enrollment Period

7 months

First QC Date

October 28, 2017

Last Update Submit

May 29, 2018

Conditions

Central Serous Chorioretinopathy

Outcome Measures

Primary Outcomes (1)

  • Change in subretinal fluid (microns)

    Change in subretinal fluid as measured by optical coherence tomography

    6 months

Secondary Outcomes (6)

  • Change in ETDRS visual acuity (number of letters)

    6 months

  • Change in central macular thickness (microns)

    6 months

  • Change in choroidal thickness (microns)

    6 months

  • Time for fluid resolution (days)

    6 months

  • Percentage of patients with fluid resolution

    6 months

  • +1 more secondary outcomes

Study Arms (1)

Topical brinzolamide

EXPERIMENTAL

Brinzolamide ophthalmic, given bd for 3 months

Drug: Brinzolamide Ophthalmic

Interventions

Brinzolamide OphthalmicDRUG

Topical brinzolamide given bd for 3 months

Topical brinzolamide

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Iglicki Oftalmologia

Buenos Aires, Argentina

Location

Tel Aviv Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Dinah Zur

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dinah Zur, MD

CONTACT

+97236973408dinahzur@gmail.com

Roy Schwartz, MD

CONTACT

+447392971069royschwartz@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Chair

Study Record Dates

First Submitted

October 28, 2017

First Posted

May 31, 2018

Study Start

June 1, 2018

Primary Completion

January 1, 2019

Study Completion

April 1, 2019

Last Updated

May 31, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)AR(1)