Pred Forte® in chronic central serous chorioretinopathy
Phase 3
Recruiting
- Conditions
- central serous chorioretinopathyCSC10047060
- Registration Number
- NL-OMON51739
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Diagnosis of severe chronic central serous chorioretinopathy that meets the
criteria outlined in section 6.1 of protocol
- 18 years or older
- doesn*t meet any exclusion criteria, is willing to sign the consent form
- able to self-administer eye drops.
Exclusion Criteria
- evidence of another retinal diagnoses, such as exudative age-related macular
degeneration, suspicion of secondary choroidal neovascularization, polypoidal
choroidal vasculopathy, multifocal choroiditis, retinal vascular occlusions,
pseudoxanthoma elasticum, amblyopia, and severe myopia (more than *6 dioptres).
- women that are breast feeding or pregnant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To investigate whether PF® topical eye drops lead to a reduction of<br /><br>intraretinal and subretinal fluid after 4 weeks in comparison to placebo eye<br /><br>drops. Treatment response is objectified by OCT</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints in this study are changes in best-corrected visual acuity<br /><br>and changes on multimodal imaging. </p><br>