Reduced Fluence Photodynamic Therapy (PDT) With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration
Condition: Age-Related Maculopathy; Choroidal Neovascularization
MeSH terms: Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic
Intervention: Ranibizumab; Verteporfin; Verteporfin
Intervention description: intravitreal administered ranibizumab 0.5 mg in 0.05 mL; Verteporfin with 50% fluence photodynamic therapy (25 J/cm2); Verteporfin with standard fluence photodynamic therapy (50 J/cm2)
Intervention MeSH terms: Ranibizumab; Verteporfin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Ranibizumab; Lucentis; Verteporfin; Visudyne; Photodynamic therapy

Summary:

      In this pilot study the researchers will evaluate the safety and efficacy of 50% reduced
      fluence PDT combination therapy with ranibizumab. The researchers hope to gain information
      regarding the use of reduced fluence PDT combination therapy. The information gained from
      this pilot study may prompt further definitive studies comparing the safety and efficacy of
      both standard fluence PDT combination therapy, reduced fluence PDT combination therapy, and
      ranibizumab monotherapy.

      The study will compare the use of combination therapy with ranibizumab and verteporfin PDT to
      ranibizumab alone in patients with exudative age-related macular degeneration (AMD). All
      patients will receive three consecutive monthly treatments with ranibizumab. Patients will be
      randomized 1:1:1 to 3 groups. Patients randomized to group 1 will receive only ranibizumab.
      Patients randomized to group 2 will also receive one treatment with reduced fluence (50%
      fluence) verteporfin PDT at day 0. Patients randomized to group 3 will also receive one
      treatment with standard fluence verteporfin PDT. All patients will also be evaluated for
      possible retreatment with ranibizumab and verteporfin PDT according to established criteria.
      Thirty patients will be recruited from one U.S. sites. Randomization will occur at the time
      of entry into the study. Follow-up will continue until month 12 (from day 0) in all subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or Female Patients > 50 years of age.

          2. Patients with primary subfoveal CNV secondary to AMD documented on IVFA and/or OCT.

          3. Patient with BCVA of 20/40 to 20/320 in the study eye using Early Treatment Diabetic
             Retinopathy Study (ETDRS) charts. See definition of ETDRS charts.

          4. If both eyes are eligible, only one eye will be evaluated in the study. The eye with
             lesser visual acuity will be selected as the study eye.

          5. Patients must be able and willing to provide written informed consent.

        Exclusion Criteria:

          1. Patients receiving prior treatment in the study eye with verteporfin, any focal laser
             photocoagulation, vitrectomy, or intravitreous injection of antiangiogenic
             medications, including triamcinolone, pegaptanib, bevacizumab, or ranibizumab.

          2. Neovascular membrane from any other retinal disease such as myopic degeneration,
             histoplasmosis, retinal angiomatous proliferation, or other ocular inflammatory
             disease.

          3. Choroidal neovascular membrane greater than 9 disc diameters in size.

          4. Previous posterior vitrectomy in the study eye.

          5. Concurrent disease in the study eye that could compromise visual acuity or require
             medical or surgical intervention during the study period.

          6. Pregnant women or premenopausal women not using adequate contraception.

          7. History of allergy to fluorescein, Visudyne, Lucentis.

          8. Inability to comply with study or follow up procedures.