NCT00423189

Lucentis Utilizing Visudyne (LUV Trial) Combination Therapy in the Treatment of Age-Related Macular Degeneration

Lucentis Utilizing Visudyne (LUV Trial)-- Reduced Fluence Photodynamic Therapy With Visudyne Combined With Intravitreal Ranibizumab in the Treatment of Age-Related Macular Degeneration

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: David M. Brown, M.D. · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Ranibizumab (Lucentis)	as needed, one intravitreal injection of 0.50mg ranibizumab
DRUG	0.5mg ranibizumab	as needed, one intravitreal injection of 0.50mg ranibizumab

Timeline

• Start date: 2007-01-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2007-01-18
• Last updated: 2016-03-04
• Results posted: 2016-03-04

Locations

1 site across 1 country: United States