|
|
|
|
|
|
Sponsors and Collaborators: |
Barnes Retina Institute QLT Inc |
Information provided by: | Barnes Retina Institute |
ClinicalTrials.gov Identifier: | NCT00455871 |
The purpose of this study is to determine the benefits, if any, of combination therapy with Lucentis plus reduced fluence photodynamic therapy with Visudyne.
Condition | Intervention |
Age-Related Macular Degeneration |
Drug: reduced fluence photodynamic therapy with Visudyne Drug: Lucentis |
Genetics Home Reference related topics: | X-linked juvenile retinoschisis |
MedlinePlus related topics: | Macular Degeneration |
Drug Information available for: | Ranibizumab Verteporfin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Single-Site, Comparative, Pilot Study of the Treatment Effects of Combination Therapy of Lucentis (Ranibizumab) Plus Reduced Fluence Photodynamic Therapy With Visudyne in Patients With Exudative Age-Related Macular Degeneration (AMD) |
Estimated Enrollment: | 30 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Lucentis plus Reduced Fluence PDT same day: Active Comparator |
Drug: reduced fluence photodynamic therapy with Visudyne
reduced fluence photodynamic therapy with visudyne
Drug: Lucentis
Lucentis intravitreal injection
|
Lucentis plus reduced fluence PDT 1-2 weeks later: Active Comparator |
Drug: reduced fluence photodynamic therapy with Visudyne
reduced fluence photodynamic therapy with visudyne
Drug: Lucentis
Lucentis intravitreal injection
|
The study will have two treatment groups. Each group will receive intravitreal injections (injection of medication in the jelly-like part of the back of the eye). One group (Group1) of approximately 15 patients will receive 0.5 mg of Lucentis™ followed by reduced fluence Photodynamic Therapy (PDT) with Visudyne ® 1-2 weeks later. The other group (Group 2) of approximately 15 patients will receive 0.5 mg of Lucentis™ followed by Photodynamic Therapy with Visudyne on the same day. patients will be assigned at random to receive one of the two treatments arms in the study. The dose received at the first injection will be the same dose received throughout the study.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Occult with no classic CNV lesions must have presumed recent disease progression:
Contact: Pamela A Light, CCRC | 314-367-1278 ext 2287 | bristudies@barnesretinainstitute.com |
Contact: Rhonda F Weeks | 314-367-1278 ext 2240 | bristudies@barnesretinainstitute.com |
United States, Missouri | |||||
Barnes Retina Institute | Recruiting | ||||
St. Louis, Missouri, United States, 63110 | |||||
Principal Investigator: Gaurav K Shah, MD |
Barnes Retina Institute |
QLT Inc |
Principal Investigator: | Gaurav K. Shah, MD | Barnes Retina Institute |
Responsible Party: | Barnes Retina Institute ( Gaurav Shah, M.d. ) |
Study ID Numbers: | 06-0769, NCT00455871 |
First Received: | April 2, 2007 |
Last Updated: | May 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00455871 |
Health Authority: | United States: Food and Drug Administration |
|
|
|
|
|