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Sponsors and Collaborators: |
Manhattan Eye, Ear & Throat Hospital Novartis QLT Inc |
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Information provided by: | Manhattan Eye, Ear & Throat Hospital |
ClinicalTrials.gov Identifier: | NCT00140803 |
To determine whether VISUDYNE therapy in combination with 4 mg intravitreal triamcinolone will reduce the average loss from baseline of best corrected visual acuity (BCVA) as compared with Visudyne therapy without intravitreal triamcinolone at 12 months in subjects with occult subfoveal and minimally classic subfoveal CNV secondary to AMD. The intravitreal triamcinolone will be given as either a 1 mg or 4 mg dose. This study will also evaluate the safety of Visudyne therapy in combination with intravitreal triamcinolone. An interim statistical readout will be performed when the first 60 patients have completed 6 months of follow-up evaluation.
Condition | Intervention | Phase |
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Age-Related Macular Degeneration |
Drug: Visudyne Drug: Kenalog |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Single-Masked, Multi-Center, Phase 2 Evaluation Of The Effect Of PDT Using Visudyne In Combination With Intravitreal Injection Of Either 0 mg, 1mg or 4mg of Kenalog In Subfoveal Occult & Minimally Classic CNV Secondary To ARMD |
Enrollment: | 106 |
Study Start Date: | October 2003 |
Study Completion Date: | January 2007 |
This is a randomized, single-masked (VA examiners, angiographic graders), multi-center, Phase 2 study with 3 arms comparing VISUDYNE therapy in combination with intravitreal injection of either a 1 mg or 4 mg of triamcinolone with VISUDYNE therapy without intravitreal triamcinolone in a 1:1:1 ratio.
Re-treatment may be administered at 3 month intervals ( 14 days) if evidence of CNV leakage is detected by fluorescein angiography.
At baseline and at 3 month (+ 14 days) intervals patients will undergo the following assessments: ophthalmic examination, best corrected visual acuity, fluorescein angiography, and color fundus photography. The eligibility criteria for inclusion into the study and re-treatment of patients will be based on fluorescein angiography. Patients receiving treatment at day-1, week-3, and week-6 following the treatment will have best corrected ETDRS visual acuity testing and ophthalmic. Those patients not being re-treated will have will have best corrected ETDRS visual acuity testing and ophthalmic examination at week-6 following the re-treatment evaluation visit.
Adverse events will be assessed throughout the study.
Expected time for recruitment is 6 months; all patients will be followed for the period of 12 months in the study
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
• Age 50 years or older
Exclusion Criteria:
Subjects may not be randomized to treatment if they:
United States, New York | |
Manhattan Eye, Ear & Throat Hospital | |
New York, New York, United States, 10021 | |
Canada, British Columbia | |
Vh/UBC Eye Care Centre | |
Vancouver, British Columbia, Canada, V5Z 3N9 |
Principal Investigator: | Richard F. Spaide, MD | Manhattan Eye, Ear & Throat Hospital |
Study ID Numbers: | VISTA |
Study First Received: | August 30, 2005 |
Last Updated: | July 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00140803 |
Health Authority: | Canada: Ethics Review Committee; United States: Food and Drug Administration |
Triamcinolone Acetonide Eye Diseases Triamcinolone Verteporfin Neoplasm Metastasis Retinal Degeneration |
Macular Degeneration Triamcinolone diacetate Retinal Diseases Triamcinolone hexacetonide Retinal degeneration |
Anti-Inflammatory Agents Photosensitizing Agents Radiation-Sensitizing Agents Immunologic Factors Therapeutic Uses Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Dermatologic Agents Immunosuppressive Agents Hormones Glucocorticoids Pharmacologic Actions |