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Monoclonal Antibodies
Pre-PDT for Visual Acuity
Phase 4
Waitlist Available
Led By John Galic, MD
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
Study Summary
The purpose of the investigators study is to look at the visual outcomes of Ranibizumab injections in combination with photodynamic therapy for the treatment of neovascular age-related macular degeneration.
Eligible Conditions
- Visual Acuity
- Age-Related Macular Degeneration
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean change from baseline at 6 months in the best corrected visual acuity (VA) score using an early treatment diabetic retinopathy study eye chart at a starting distance of 4 meters.
Secondary outcome measures
To determine the following: 1:Proportion of subjects who loose fewer than 15 letters from baseline visual acuity at 6 months 2: Proportion of subjects with VA of 20/200 or worse 3: Proportion of subjects with VA of 20/40 or better
Trial Design
3Treatment groups
Active Control
Group I: Pre-PDTActive Control1 Intervention
Participants in this group will receive an intraocular Ranibizumab injection one week prior to the first PDT with verteporfin.
Group II: No PDTActive Control1 Intervention
Participants in this group will receive an intraocular Ranibizumab injection with no accompanying PDT with verteporfin.
Group III: Post-PDTActive Control1 Intervention
Participants in this group will receive an intraocular Ranibizumab injection one week post the first PDT with verteporfin.
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Who is running the clinical trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
444 Previous Clinical Trials
159,368 Total Patients Enrolled
John Galic, MDPrincipal InvestigatorMontreal Retina Institute
John Chen, MDPrincipal InvestigatorMontreal Retina Institute
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