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Brinzolamide for the Treatment of Chronic Central Serous Chorioretinopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03542006
Recruitment Status : Unknown
Verified May 2018 by Michaella Goldstein, Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 31, 2018
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Michaella Goldstein, Tel-Aviv Sourasky Medical Center

Brief Summary:
Examine the efficacy of brinzolamide for the treatment of central serous chorioretinopathy

Condition or disease Intervention/treatment Phase
Central Serous Chorioretinopathy Drug: Brinzolamide Ophthalmic Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Brinzolamide for the Treatment of Chronic Central Serous Chorioretinopathy
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Topical brinzolamide
Brinzolamide ophthalmic, given bd for 3 months
Drug: Brinzolamide Ophthalmic
Topical brinzolamide given bd for 3 months




Primary Outcome Measures :
  1. Change in subretinal fluid (microns) [ Time Frame: 6 months ]
    Change in subretinal fluid as measured by optical coherence tomography


Secondary Outcome Measures :
  1. Change in ETDRS visual acuity (number of letters) [ Time Frame: 6 months ]
    Change in visual acuity from baseline to last follow-up in ETDRS letters

  2. Change in central macular thickness (microns) [ Time Frame: 6 months ]
    Change in central macular thickness in microns from baseline to last follow-up

  3. Change in choroidal thickness (microns) [ Time Frame: 6 months ]
    Change in choroidal thickness in microns from baseline to last follow-up

  4. Time for fluid resolution (days) [ Time Frame: 6 months ]
    Time in days from baseline until fluid resolution, as measured on optical coherence tomography

  5. Percentage of patients with fluid resolution [ Time Frame: 6 months ]
    Percentage of patients with fluid resolution by last follow-up as seen on optical coherence tomography, out of all study participants

  6. Quality of life assessment (using NEI-VFQ-25 questionnaires) [ Time Frame: 6 months ]
    Quality of life score as assessed by standard questionnaires



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03542006


Contacts
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Contact: Dinah Zur, MD +97236973408 dinahzur@gmail.com
Contact: Roy Schwartz, MD +447392971069 royschwartz@gmail.com

Locations
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Argentina
Iglicki Oftalmologia
Buenos Aires, Argentina
Contact: Matias Iglicki    +5491148562937    matiasiglicki@gmail.com   
Israel
Tel Aviv Medical Center
Tel Aviv, Israel
Contact: Dinah Zur, MD    +97226973408      
Contact: Roy Schwartz, MD    +447392971069    royschwartz@gmail.com   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Dinah Zur Tel-Aviv Sourasky Medical Center
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Responsible Party: Michaella Goldstein, Study Chair, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT03542006    
Other Study ID Numbers: 0647-17
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases
Brinzolamide
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action