Conditions: Age-Related Maculopathy Choroidal Neovascularization
Keywords: Ranibizumab Lucentis Verteporfin Visudyne Photodynamic therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 31
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Standard Fluence Photodynamic Therapy combined with ranibizumab arm 2: Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab arm 3: Ranibizumab monotherapy

Interventions: intervention 1: Ranibizumab intervention 2: Verteporfin intervention 3: Verteporfin
Intervention descriptions: intervention 1: intravitreal administered ranibizumab 0.5 mg in 0.05 mL intervention 2: Verteporfin with 50% fluence photodynamic therapy (25 J/cm2) intervention 3: Verteporfin with standard fluence photodynamic therapy (50 J/cm2)

Protocol document: