Phase 2
Completed N=34
Ranibizumab Versus Low-fluence Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinopathy
Source: ClinicalTrials.gov NCT01325181 ↗Enrolled (actual)
34
Serious AEs
—
Results posted
May 2013
Primary outcomePrimary: Number of Participants That Achieved Complete Resolution of Subretinal Fluid on OCT Without Rescue Treatment — 16; 2 participants
Summary
The purpose of this study is to compare the efficacy and safety of intravitreal ranibizumab injection versus low-fluence PDT in the treatment of chronic CSC.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Achieved Complete Resolution of Subretinal Fluid on OCT Without Rescue Treatment |
16; 2 | — |
| SECONDARY Change From Baseline in logMAR BCVA |
— | — |
| SECONDARY Change From Baseline in Central Foveal Thickness on OCT |
— | — |
| SECONDARY Number of Participants With Leakage on Fluorescein Angiography |
— | — |
| SECONDARY Change From Baseline in Choroidal Hyperpermeability on Indocyanine Green Angiography |
— | — |
| SECONDARY Number of Participants Who Underwent Rescue Treatment |
— | — |
| SECONDARY Number of Participants With Adverse Event |
— | — |
Eligibility Criteria
Inclusion Criteria
- best-corrected visual acuity (BCVA) between 0.0 and 1.0 logarithm of the minimal angle of resolution (logMAR)
- presence of subfoveal fluid persisting for 3 months or more on optical coherence tomography (OCT)
- presence of leakage and multifocal/diffuse RPE decompensation on fluorescein angiography (FA)
- choroidal vascular hyperpermeability and abnormal dilation of choroidal vasculature on indocyanine angiography (ICGA)
Exclusion Criteria
- previous treatment, such as laser photocoagulation, PDT, intravitreal injection of steroid or anti-VEGF agent
- evidence of choroidal neovascularization
- any other ocular diseases that could affect visual acuity
- systemic steroid treatment in the previous 12 months
- media opacity such as cataract that could interfere with adequate acquisition of OCT, FA and ICGA images
Data sourced from ClinicalTrials.gov (NCT01325181). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.