Visual Outcome in Patients With Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV) Treated With Either Ranibizumab as Monotherapy or Combined With Verteporfin Photodynamic Therapy (vPDT)

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01846273
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    Intravitreal injection of 0.5 mg ranibizumab
  • Verteporfin PDT — DRUG
    Infusion of 30 ml verteporfin in 5% dextrose solution followed by 83 sec of laser light (50J/cm2; 600mW/cm2; 689 nm)
  • Sham PDT — DRUG
    Infusion of 30 ml 5% dextrose solution followed by 83 sec of laser light (50J/cm2; 600mW/cm2; 689 nm)

Study Details

This study compared the effect of ranibizumab administered as monotherapy versus ranibizumab administered in combination with verteporfin photodynamic therapy (PDT) on visual acuity in patients with symptomatic macular polypoidal choroidal vasculopathy (PCV). The results of this study provided long-term safety and efficacy data used to generate further guidance on the management of patients with PCV.

Key Dates

Start date
Aug 7, 2013
Status verified
Mar 2019
Primary completion
Mar 11, 2016
Completion
Mar 2, 2017

Study Design

Enrollment
321 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ranibizumab + vPDT
    Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT) determined at monthly visits based on defined retreatment criteria
  • Active Comparator: Ranibizumab monotherapy
    Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT) determined at monthly visits based on defined retreatment criteria

Primary Outcome Measure

Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 - Study Eye [ Time Frame: Baseline, Month 12 ]

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