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

Completed · Phase 2

Conditions studied: Age-Related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT00140803

Run by

Manhattan Eye, Ear & Throat Hospital

People needed

106

Starts

2003-10-01

Expected to finish

2007-01-01

Last updated by the study team

2007-07-12

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• • 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.

You may not qualify if…

• 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.

Where it is running

• Manhattan Eye, Ear & Throat Hospital — New York, New York, United States
• Vh/UBC Eye Care Centre — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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