Status:
COMPLETED
Study Of Combined VISUDYNE Therapy With Kenalog In CNV Secondary To Age-Related Macular Degeneration
Lead Sponsor:
Manhattan Eye, Ear & Throat Hospital
Collaborating Sponsors:
Novartis
QLT Inc.
Conditions:
Age-Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
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 th...
Detailed Description
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...
Eligibility Criteria
Inclusion
- • Age 50 years or older
- Subfoveal CNV secondary to age-related macular degeneration
- Area of the CNV at least 50% of the area of the total neovascular lesion
- The lesion is either minimally classic or occult with no classic
- If the lesion is occult with no classic then subjects must have presumed recent disease progression in the study eye in the judgment of the Investigator and as defined by presence of blood associated with the lesion or vision loss or lesion growth reported or objectively recorded within the preceding 3 months before randomization to treatment
- Baseline BCVA score between 73 and 19 letters on the ETDRS scale (approximately 20/40 to 20/400)
- Lesion size \< 5400 microns
- Ability and willingness to provide written informed consent.
Exclusion
- Subjects may not be randomized to treatment if they:
- Have evidence of predominantly classic CNV, clinically significant intraocular inflammation, angioid streaks, presumed ocular histoplasmosis syndrome, axial myopia greater than -6 diopters, or other precursors of choroidal neovascularization
- Have additional eye disease that compromises the visual acuity of the study eye.
- Are receiving or require chronic concomitant therapy with systemic or topical ocular corticosteroids or NSAIDS. Chronic concomitant therapy is defined as multiple doses taken daily for 3 or more consecutive days at any time during the course of the 12-month study). A low dose (up to 100 mg po qd) of aspirin (ASA) taken for prophylaxis of MI and/or stroke is permitted during the study.
- Are using coumadin.
- Have known hypersensitivity to verteporfin or triamcinolone
- Have CNV that does not involve the geometric center of the foveal avascular zone, as determined by color photography and fluorescein angiography
- Are unable to be photographed to document CNV, e.g. due to media opacity, allergy to fluorescein dye or lack of venous access
- Have lens opacities which, in the investigator's opinion, would progress during the course of the study and would affect central vision in the study eye. Such cataracts may be removed at least 2 months before entering the subject in the study
- Have a history of treatment for CNV, other than confluent laser photocoagulation, in the study eye (e.g., PDT, submacular surgery, radiotherapy or macular scatter "grid" laser photocoagulation
- Are participating in another clinical trial requiring follow-up examinations or are receiving or have received any experimental treatment for CNV or any other investigational new drug within 12 weeks prior to the start of study treatment
- Have an intraocular pressure greater than 21 mm Hg on or off medication on entry to the study.
- Have received prior treatment with another anti-angiogenic compound (e.g., Sandostatin®, LY333531, Macugen, RhuFab, etc.) within 6 months prior to screening
- Are unwilling or unable to follow or comply with all study-related procedures.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00140803
Start Date
October 1 2003
End Date
January 1 2007
Last Update
July 12 2007
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Manhattan Eye, Ear & Throat Hospital
New York, New York, United States, 10021
2
Vh/UBC Eye Care Centre
Vancouver, British Columbia, Canada, V5Z 3N9