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

NCT00140803 | Completed Phase 2 DMC

• 1 other identifier: VISTA
• Study Type: interventional
• Target: 106
• Locations: 2 countries
• Sites: 2

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 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.

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (6)

• • Proportion of patients having a 15 letter (3 lines) loss or more in BCVA

  12 months

• • Proportion of patients having a 15 letter (3 lines) improvement or more in BCVA

  12 months

• • Proportion of patients requiring re-treatment at any time during the study

  12 months

• • The number of re-treatments required

  12 months

• • Difference in treatment effect between 1 mg and 4 mg of triamcinolone acetonide

  12 months

Interventions

Visudyne DRUG

Kenalog DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Manhattan Eye, Ear & Throat Hospital: lead
• Novartis: collaborator
• QLT Inc.: collaborator

Study Sites (2)

Manhattan Eye, Ear & Throat Hospital

New York, New York, 10021, United States

Location

Vh/UBC Eye Care Centre

Vancouver, British Columbia, V5Z 3N9, Canada

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Verteporfin; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Study Officials

• Richard F. Spaide, MD

  Manhattan Eye, Ear & Throat Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Expanded Access: Yes

Study Record Dates

• First Submitted: August 30, 2005
• First Posted: September 1, 2005
• Study Start: October 1, 2003
• Study Completion: January 1, 2007
• Last Updated: July 12, 2007

Record last verified: 2007-07

Locations

CA (1); US (1)