Efficacy of Ranibizumab in Combination With Photodynamic Therapy for Wet Age-Related Macular Degeneration

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study ID
NCT00813891
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    Intraocular injection of 0.5mg of Ranibizumab one week prior to PDT with verteporfin
  • Ranibizumab — DRUG
    Intraocular injection of 0.5mg of Ranibizumab one week after PDT with verteporfin
  • Ranibizumab — DRUG
    Intraocular injection of 0.5mg of Ranibizumab with no accompanying PDT with verteporfin

Study Details

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.

Key Dates

First listed
Dec 23, 2008
Start date
Jan 31, 2009
Status verified
Dec 2008
Primary completion
Dec 31, 2009
Completion
Dec 31, 2009

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Pre-PDT
    Participants in this group will receive an intraocular Ranibizumab injection one week prior to the first PDT with verteporfin.
  • Active Comparator: Post-PDT
    Participants in this group will receive an intraocular Ranibizumab injection one week post the first PDT with verteporfin.
  • Active Comparator: No PDT
    Participants in this group will receive an intraocular Ranibizumab injection with no accompanying PDT with verteporfin.

Primary Outcome Measure

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. [ Time Frame: Monthly for a total of 12 months ]

Central Contacts

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