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Sponsors and Collaborators: |
Oklahoma State University Center for Health Sciences Novartis |
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Information provided by: | Oklahoma State University Center for Health Sciences |
ClinicalTrials.gov Identifier: | NCT00473642 |
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.
Condition | Intervention | Phase |
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Age-Related Maculopathy Choroidal Neovascularization |
Drug: Ranibizumab Drug: Verteporfin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective Pilot Study of Reduced Fluence Photodynamic Therapy With Visudyne® (Verteporfin) in Combination With Lucentis™ (Ranibizumab) for the Treatment of Age-Related Macular Degeneration |
Estimated Enrollment: | 30 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Standard Fluence Photodynamic Therapy combined with ranibizumab
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Drug: Ranibizumab
intravitreal administered ranibizumab 0.5 mg in 0.05 mL
Drug: Verteporfin
Verteporfin with standard fluence photodynamic therapy (50 J/cm2)
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2: Experimental
Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
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Drug: Ranibizumab
intravitreal administered ranibizumab 0.5 mg in 0.05 mL
Drug: Verteporfin
Verteporfin with 50% fluence photodynamic therapy (25 J/cm2)
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3: Active Comparator
Ranibizumab monotherapy
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Drug: Ranibizumab
intravitreal administered ranibizumab 0.5 mg in 0.05 mL
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Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Scott J Westhouse, DO | 918-747-7799 | westhouses@hotmail.com |
Contact: Diana Graham | 918-747-7799 | DGraham@retinasupport.com |
United States, Oklahoma | |
Eagle Mountain Vision | Recruiting |
Tulsa, Oklahoma, United States, 74132 | |
Contact: Diana Graham 918-747-7799 DGraham@retinasupport.com |
Principal Investigator: | Scott J Westhouse, DO | Oklahoma State University Medical Center |
Principal Investigator: | Raymond Townsend, MD | Oklahoma State University Medical Center |
Principal Investigator: | John Saurino, DO | Oklahoma State University Medical Center |
Responsible Party: | Oklahoma State University Medical Center ( Scott J. Westhouse, DO ) |
Study ID Numbers: | 2007002 |
Study First Received: | May 14, 2007 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00473642 |
Health Authority: | United States: Food and Drug Administration |
Ranibizumab Lucentis Verteporfin Visudyne Photodynamic therapy |
Metaplasia Eye Diseases Choroid Diseases Verteporfin Retinal Degeneration |
Macular Degeneration Neovascularization, Pathologic Retinal Diseases Retinal degeneration Choroidal Neovascularization |
Photosensitizing Agents Uveal Diseases Pathologic Processes Radiation-Sensitizing Agents |
Therapeutic Uses Physiological Effects of Drugs Dermatologic Agents Pharmacologic Actions |