NCT01574430CompletedPhase 4
A Randomized, Double-masked, Multicenter, Controlled Study of Photodynamic Therapy in Patients With Central Serous Chorioretinopathy
Peking University People's Hospital1 site in 1 country131 target enrollmentStarted: December 1, 2010Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 131
- Locations
- 1
- Primary Endpoint
- Change from baseline in BCVA
Study Overview
Brief Summary
The purpose of this study is to determine the safety and efficacy of PDT at 30% verteporfin dose in the treatment of CSC.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with CSC
- •patients signed the ICF
- •patients with course of CSC less than 6 months
- •patients did not undertake any treatment for CSC
Exclusion Criteria
- •patients with porphyria
- •patients allergic to verteporfin
- •pregnant or nursing women
- •poor patients compliance
- •sever liver dysfunction
- •dioptric media opacities which make it difficult to exam fundus
Arms & Interventions
30% dose PDT
Experimental
patients in this group was given 30% verteporfin dose PDT
Intervention: PDT (Procedure)
50% dose PDT
Active Comparator
patients in this group was given 50% verteporfin dose PDT
Intervention: PDT (Procedure)
Outcomes
Primary Outcomes
Change from baseline in BCVA
Time Frame: 1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year
Secondary Outcomes
- The incidence rate of adverse event(1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year)
- Leakage at RPE level in FA(1 week)
- Change from baseline in central retinal thickness(1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year)
Investigators
Mingwei Zhao
Dr.
Peking University People's Hospital
Study Sites (1)
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