Brinzolamide for the Treatment of Chronic Central Serous Chorioretinopathy
- Registration Number
- NCT03542006
- Lead Sponsor
- Tel-Aviv Sourasky Medical Center
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 35
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Topical brinzolamide Brinzolamide Ophthalmic Brinzolamide ophthalmic, given bd for 3 months
- Primary Outcome Measures
Name Time Method Change in subretinal fluid (microns) 6 months Change in subretinal fluid as measured by optical coherence tomography
- Secondary Outcome Measures
Name Time Method Time for fluid resolution (days) 6 months Time in days from baseline until fluid resolution, as measured on optical coherence tomography
Percentage of patients with fluid resolution 6 months Percentage of patients with fluid resolution by last follow-up as seen on optical coherence tomography, out of all study participants
Change in choroidal thickness (microns) 6 months Change in choroidal thickness in microns from baseline to last follow-up
Quality of life assessment (using NEI-VFQ-25 questionnaires) 6 months Quality of life score as assessed by standard questionnaires
Change in ETDRS visual acuity (number of letters) 6 months Change in visual acuity from baseline to last follow-up in ETDRS letters
Change in central macular thickness (microns) 6 months Change in central macular thickness in microns from baseline to last follow-up
Trial Locations
- Locations (2)
Tel Aviv Medical Center
🇮🇱Tel Aviv, Israel
Iglicki Oftalmologia
🇦🇷Buenos Aires, Argentina