Efficacy and Safety of Verteporfin Added to Ranibizumab in the Treatment of Symptomatic Macular Polypoidal Choroidal Vasculopathy
Condition: Polypoidal Choroidal Vasculopathy
MeSH terms: Polypoidal Choroidal Vasculopathy; Vascular Diseases
Intervention: Verteporfin Photodynamic Therapy; Ranibizumab
Intervention description: After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m^2 body surface area, light application of 50 J/cm^2 to the study eye was begun 15 minutes after the start of infusion.; Ranibizumab at dose of 0.5 mg administered as an intravitreal injection.
Intervention MeSH terms: Ranibizumab; Verteporfin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Polypoidal choroidal vasculopathy; PCV; Age-related macular degeneration (AMD) variant; vision; polyps; indocyanine green angiography; verteporfin; ranibizumab; photodynamic therapy

Summary:

      This study aims to compare the efficacy of ranibizumab and verteporfin PDT combination
      treatment and verteporfin PDT monotherapy vs.ranibizumab monotherapy alone in achieving
      complete regression of polyps in patients with symptomatic macular polypoidal choroidal
      vasculopathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must give written informed consent before any assessment is performed.

          -  Male or Female patients ≥18 yrs of age

          -  Patients willing and able to comply with all study procedures

        Inclusion criteria for study eye:

          -  BCVA letter score between 73-24 (approximately 20/40 to 20/320 Snellen equivalent)
             using ETDRS visual acuity chart measured at 4 meters

          -  PCV diagnosis confirmed by Central Reading Center

          -  Greatest Linear Dimension (GLD) of the total lesion area < 5400 µm (~9 Macular
             Photocoagulation Study Disc Areas)

        Exclusion Criteria:

          -  Women of child-bearing potential who are not using one or more reliable contraception
             methods

          -  Pregnant or nursing (lactating) women

          -  History of hypersensitivity or allergy to fluorescein or indocyanine green (ICG),
             clinically significant drug allergy or known hypersensitivity to therapeutic or
             diagnostic protein products, or to any of the study drugs or their components

          -  Patient with history of porphyria

          -  Systemic medications known to be toxic to the lens, retina, or optic nerve

          -  History of which might affect the interpretation of the results of the study, or
             renders the patient at high risk from treatment complications

          -  Use of other investigational drugs within 30 days of randomization

        Exclusion criteria for study eye:

          -  Concomitant conditions/diseases:

          -  Presence of angioid streaks, macular fibrosis, presumed ocular histoplasmosis
             syndrome, pathologic myopia (-8 Diopters or more)

          -  Active ocular inflammation or infection

          -  Uncontrolled glaucoma

          -  Ocular disorders that may confound interpretation of study results

        Prior Ocular treatment:

          -  Prior Verteporfin PDT, external-beam radiation, laser photocoagulation, macular
             surgery, or transpupillary thermotherapy

          -  Prior local treatment with Pegaptanib, Ranibizumab, Bevacizumab or other
             anti-angiogenic compound or any investigational treatment in both eyes or systemic use
             of bevacizumab within 90 days prior to randomization

          -  History of intraocular surgery including pars plana vitrectomy and intraocular
             hemorrhage displacement is not allowed with the exception of uncomplicated cataract
             surgery that is allowed within 60 days prior to screening

          -  Ocular conditions that required chronic concomitant therapy within 90 days prior to
             randomization with topical, ocular, or systemically administered corticosteroids or
             any herbal medication known to contain steroid-like components

        Other protocol-defined inclusion/exclusion criteria may apply