Central Serous ChorioretinopathyPhase 2NCT03542006
Brinzolamide for the Treatment of Chronic Central Serous Chorioretinopathy
A Phase 2 study testing Brinzolamide Ophthalmic in people with Central Serous Chorioretinopathy, run by Tel-Aviv Sourasky Medical Center at 2 sites in 2 countries.
Trial summary
Examine the efficacy of brinzolamide for the treatment of central serous chorioretinopathy Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Central Serous Chorioretinopathy
- What is being tested?
- Brinzolamide Ophthalmic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jun 2018to 1 Apr 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Argentina1 site
Iglicki Oftalmologia
Buenos Aires
Matias Iglicki, +5491148562937, matiasiglicki@gmail.com
Israel1 site
Tel Aviv Medical Center
Tel Aviv
Dinah Zur, MD, +97226973408
Roy Schwartz, MD, +447392971069, royschwartz@gmail.com
About this study
Examine the efficacy of brinzolamide for the treatment of central serous chorioretinopathy
Read the 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.
- Conditions
- Central Serous Chorioretinopathy
- Being tested
- Brinzolamide Ophthalmic
- Medical subject headings
- Central Serous Chorioretinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brinzolamide OphthalmicDrug
Topical brinzolamide given bd for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Topical brinzolamide | Experimental | Brinzolamide ophthalmic, given bd for 3 months Receives: Drug: Brinzolamide Ophthalmic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in subretinal fluid (microns)
Change in subretinal fluid as measured by optical coherence tomography
Measured: 6 months
Secondary outcomes (6)
Change in ETDRS visual acuity (number of letters)
Change in visual acuity from baseline to last follow-up in ETDRS letters
Measured: 6 months
Change in central macular thickness (microns)
Change in central macular thickness in microns from baseline to last follow-up
Measured: 6 months
Change in choroidal thickness (microns)
Change in choroidal thickness in microns from baseline to last follow-up
Measured: 6 months
Time for fluid resolution (days)
Time in days from baseline until fluid resolution, as measured on optical coherence tomography
Measured: 6 months
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
Measured: 6 months
Quality of life assessment (using NEI-VFQ-25 questionnaires)
Quality of life score as assessed by standard questionnaires
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start1 Jun 2018 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Serous ChorioretinopathyStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Michaella Goldstein, Tel-Aviv Sourasky Medical Center
- Investigators
- Dinah Zur, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542006
- Sponsor's protocol ID
- 0647-17
- Status last verified
- May 2018
- First submitted
- 28 Oct 2017
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brinzolamide for the Treatment of Chronic Central Serous Chorioretinopathy
- ClinicalTrials.gov ID
- NCT03542006
- Acronym / sponsor ID
- 0647-17
- Conditions
- Central Serous Chorioretinopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 31 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topical brinzolamide | Experimental | Drug: Brinzolamide OphthalmicBrinzolamide ophthalmic, given bd for 3 months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brinzolamide OphthalmicTopical brinzolamide given bd for 3 months | Drug | Topical brinzolamide |
Primary outcome
Change in subretinal fluid (microns)
Time frame: 6 months
Change in subretinal fluid as measured by optical coherence tomography
6 secondary outcomes
Change in ETDRS visual acuity (number of letters)
Time frame: 6 months
Change in central macular thickness (microns)
Time frame: 6 months
Change in choroidal thickness (microns)
Time frame: 6 months
Time for fluid resolution (days)
Time frame: 6 months
Percentage of patients with fluid resolution
Time frame: 6 months
Quality of life assessment (using NEI-VFQ-25 questionnaires)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
- Individual participant dataSharing planned: No
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the Study of the Association Between the Gut Microbiota and Central Serous Chorioretinopathy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dinah Zur principal investigator
Tel-Aviv Sourasky Medical Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brinzolamide Ophthalmic in people with Central Serous Chorioretinopathy, run by Tel-Aviv Sourasky Medical Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Argentina, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dinah Zur, MD (+97236973408, dinahzur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in subretinal fluid (microns) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2018.