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Sponsored by: |
QLT Inc |
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Information provided by: | QLT Inc |
ClinicalTrials.gov Identifier: | NCT00121407 |
The purpose of this study is to demonstrate that Visudyne therapy in patients who have occult with no classic subfoveal choroidal neovascularization (CNV) lesions will, with an acceptable safety profile, significantly reduce the risk of vision loss compared with placebo (sham treatment).
Condition | Intervention | Phase |
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Macular Degeneration |
Drug: Visudyne for injection |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Placebo-Controlled, Double-Masked, Multicenter, Phase III Study of the Effect of Visudyne Therapy in Occult With No Classic Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD): Visudyne in Occult (VIO) |
Estimated Enrollment: | 364 |
Study Start Date: | March 2002 |
Estimated Study Completion Date: | August 2005 |
This is a randomized, placebo-controlled, double masked, multicenter, Phase III study. Patients will be stratified by study center and randomized to Visudyne therapy or placebo in a 2:1 ratio, respectively. Patients will receive either a single intravenous dose of Visudyne or placebo followed 15 minutes after the start of the infusion by light application. Follow-up visits will occur every three months (+/- 2 weeks) for the duration of the study.
Re-treatment may be administered every three months (through the Month 21 visit) if evidence of CNV leakage is detected by fluorescein angiography (as judged by the Investigator). At baseline and at each follow-up visit, patients will undergo the following assessments: ophthalmic examination, best-corrected visual acuity, color fundus photography, and fluorescein angiography. Indocyanine green (ICG) angiography will be conducted at baseline, Month 12, and Month 24. Optical coherence tomography (OCT) will be done at baseline, Month 3, Month 6, Month 12, and Month 24. Adverse events and concomitant medications will be assessed throughout the study.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have blood associated with the lesion or must have shown a progression of the disease within the preceding 3 months before randomization to treatment. For the purpose of this study, disease progression is defined as either:
Patients must have lesions in the study eye with the following characteristics as determined by fluorescein angiography:
Patients must meet at least one of the following criteria:
Exclusion Criteria:
Study ID Numbers: | BPD OCR 013 (VIO) |
Study First Received: | July 12, 2005 |
Last Updated: | July 19, 2005 |
ClinicalTrials.gov Identifier: | NCT00121407 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Age Related Macular Degeneration (AMD) Photodynamic Therapy (PDT) Visudyne |
Photosensitizing Agents Radiation-Sensitizing Agents Metaplasia Eye Diseases Choroid Diseases Verteporfin |
Neoplasm Metastasis Retinal Degeneration Macular Degeneration Neovascularization, Pathologic Retinal Diseases Choroidal Neovascularization |
Uveal Diseases Eye Diseases Physiological Effects of Drugs Choroid Diseases Verteporfin Macular Degeneration Retinal Degeneration Pharmacologic Actions Choroidal Neovascularization |
Photosensitizing Agents Pathologic Processes Radiation-Sensitizing Agents Therapeutic Uses Metaplasia Neovascularization, Pathologic Dermatologic Agents Retinal Diseases |