Ranibizumab Versus Low-fluence Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinopathy
- Sponsor
- Jang Won Heo
- Study ID
- NCT01325181
- Phase
- PHASE1/PHASE2
- Status
- Completed
Conditions
- Chronic Central Serous Chorioretinopathy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Verteporfin — DRUGa 6mg/m2 infusion of verteporfin(Visudyne; Novartis)over 10 minutes followed by laser delivery
- ranibizumab — DRUGConsecutive intravitreal injection of ranibizumab(Lucentis®, Novartis) 0.5mg/0.05ml for the first 3 months
Study Details
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.
Key Dates
- Start date
- Jul 31, 2009
- Status verified
- Apr 2013
- Primary completion
- Sep 30, 2012
- Completion
- Sep 30, 2012
Study Design
- Enrollment
- 34 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Low-fluence PDT with VerteporfinHalf the regular laser fluence PDT(Visudyne®; Novartis); a total light energy of 25J/cm2, a light dose rate of 300mW/cm2. If subretinal fluid was sustained after primary treatment, rescue treatment(ranibizumab injection) was considered
- Active Comparator: RanibizumabConsecutive Intravitreal injection of ranibizumab(Lucentis®, Novartis) 0.5mg/0.05ml for the first 3 months. If subretinal fluid was sustained after primary treatment, rescue treatment(low-fluence photodynamic therapy) was considered
Primary Outcome Measure
Number of Participants That Achieved Complete Resolution of Subretinal Fluid on OCT Without Rescue Treatment [ Time Frame: 12 months ]