Reduced Fluence Photodynamic Therapy (PDT) With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration
Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Oklahoma State University Center for Health Sciences