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 — DRUG
    a 6mg/m2 infusion of verteporfin(Visudyne; Novartis)over 10 minutes followed by laser delivery
  • ranibizumab — DRUG
    Consecutive 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 Verteporfin
    Half 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: Ranibizumab
    Consecutive 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 ]