Study Of Combined VISUDYNE Therapy With Kenalog In CNV Secondary To Age-Related Macular Degeneration
Manhattan Eye, Ear & Throat Hospital has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
|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|
- The primary objective of this study is to determine the effect of Visudyne therapy in combination with 4 mg intravitreal triamcinolone on the mean change in BCVA at Month 12. [ Time Frame: 12 months ]
- • Proportion of patients having a 15 letter (3 lines) loss or more in BCVA [ Time Frame: 12 months ]
- • Proportion of patients having a 15 letter (3 lines) improvement or more in BCVA [ Time Frame: 12 months ]
- • Proportion of patients requiring re-treatment at any time during the study [ Time Frame: 12 months ]
- • The number of re-treatments required [ Time Frame: 12 months ]
- • Difference in treatment effect between 1 mg and 4 mg of triamcinolone acetonide [ Time Frame: 12 months ]
- • The change in MNREAD score [ Time Frame: 12 months ]
|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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00140803
|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|