Conditions: Age-Related Macular Degeneration
Keywords: LUV Lucentis Visudyne PDT AMD ARMD Age Related Macular Degeneration
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 7
Healthy volunteers: yes

Brief summary:
The PDT/Lucentis trial will be a Phase IV comparative trial comparing the use of combination therapy with ITV ranibizumab and verteporfin PDT to ITV ranibizumab alone in patients with exudative AMD.

Detailed description:
The PDT/Lucentis trial will be a Phase IV comparative trial comparing the use of combination therapy with ITV ranibizumab and verteporfin PDT to ITV ranibizumab alone in patients with exudative AMD. Patients will be randomized to one of three groups. All patients will receive three consecutive monthly treatments with ITV ranibizumab. Patients randomized to group I will receive only ITV ranibizumab. Patients randomized to group II will also receive one treatment with reduced fluence (20% fluence) verteporfin PDT at day 0. Patients randomized to group III will also receive one treatment with reduced fluence (40% fluence) vPDT. All patients will also be evaluated for possible retreatment with ranibizumab according to established criteria. Thirty patients (ten per group) will be recruited from one U.S. sites in a 6-month period. Randomization will occur at the time of entry into the study. Follow-up will continue until month 12 (from day 0) in all subjects.

Arms:
arm 1: drug - intravitreal ranibizumab arm 2: 40% fluence photodynamic therapy-PDT therapy with 0.5mg ranibizumab arm 3: 20% fluence photodynamic therapy-PDT therapy with 0.5mg ranibizumab

Interventions: intervention 1: Ranibizumab (Lucentis) intervention 2: 0.5mg ranibizumab
Intervention descriptions: intervention 1: as needed, one intravitreal injection of 0.50mg ranibizumab intervention 2: as needed, one intravitreal injection of 0.50mg ranibizumab

Protocol document: