Study Of Combined VISUDYNE Therapy With Kenalog In CNV Secondary To Age-Related Macular Degeneration
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.
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
|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|