Comparison of PDT, Intravitreal Ranibizumab and Combination for Polypoidal Choroidal Vasculopathy Under 1+PRN Regimen

Sponsor
Sun Yat-sen University
Study ID
NCT03459144
Status
Completed

Conditions

  • Polypoidal Choroidal Vasculopathy

Eligibility Criteria

Sex
ALL
Age
40 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • verteporfin — DRUG
    Participants will receive the intravitreal ranibizumab treatment (0.05mg) at baseline and additional intravitreal ranibizumab(0.05mg) will be given to the participants when necessary（every three months）.
  • verteporfin and ranibizumab — DRUG
    Participants will be given the standard verteporfin photodynamic therapy followed by intravitreal ranibizumab (0.05mg) 72h after the PDT treatment at baseline. Additional verteporfin photodynamic therapy and intravitreal ranibizumab (0.05mg) will be given to the participants when necessary.

Study Details

The aim of this study is to compare the outcomes of different treatment methods including photodynamic therapy (PDT), intravitreal ranibizumab injection (IVR) and combination therapy under the "1+PRN" treatment regimen for polypoidal choroidal vasculopathy (PCV) and find the optimal treatment for PCV.

Key Dates

Start date
Dec 1, 2012
Status verified
Mar 2018
Primary completion
Jul 30, 2015
Completion
Jul 30, 2015

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: photodynamic therapy
    Participants will be given the standard verteporfin photodynamic therapy at baseline followed by additional standard verteporfin PDT as needed (every three months)(namely 1+PRN regimen).
  • Experimental: intravitreal ranibizumab
    Participants will receive the intravitreal ranibizumab treatment (0.05mg) at baseline and additional intravitreal ranibizumab will be given to the participants when necessary (every month) (namely 1+PRN regimen).
  • Experimental: combination therapy of PDT and IVR
    Participants will be given the standard verteporfin photodynamic therapy followed by intravitreal ranibizumab (0.05mg) 72h after the standard verteporfin PDT treatment at baseline. Additional verteporfin photodynamic therapy and intravitreal ranibizumab (0.05mg) will be given to the participants when necessary (every month)(namely 1+PRN regimen).

Primary Outcome Measure

Best corrected visual acuity [ Time Frame: 12 months ]

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