Wet AMD Recurrence Rate in Patients Stable on Three Month Ranibizumab Dosing

Sponsor
University Health Network, Toronto
Study ID
NCT01453920
Phase
PHASE4
Status
Completed

Conditions

  • Age Related Macular Degeneration

Eligibility Criteria

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

Interventions

  • Ranibizumab — DRUG
    Intravitreal Ranibizumab 0.05cc (10mg/ml)
  • Ranibizumab — DRUG
    Intravitreal Ranibizumab 0.05cc (10mg/ml)

Study Details

The current norm in clinical practice for the treatment of choroidal neovascular membranes (CNVM) secondary to Age-related Macular Degeneration(AMD) involves monthly injections of Ranibizumab until the disease is stabilized. At this point, most physicians tend to follow one of two treatment regimens. 'Treat -and-observe' entails regular follow-up of stable patients, with treatment thereafter only in the presence of disease recurrence. Alternatively, in a 'treat-and-extend' dosing strategy, intervals between treatments are extended as long as disease remains stable. Many clinicians, who employ a treat-and-extend dosing regimen, do not extend their treatment intervals beyond 3 months. However, it is possible that the subgroup of patients on every three months 'treat-and-extend' dosing may represent a uniquely, stable population that would perform particularly well on an observational regimen with regular follow-up. We hypothesize that there will be a low CNVM recurrence rate in wet AMD patients stable on every three months Ranibizumab dosing ('treat-and-extend'), who begin a treat-and-observe protocol.

Key Dates

First listed
Oct 18, 2011
Start date
Nov 30, 2011
Status verified
Aug 2012
Primary completion
Jul 31, 2012
Completion
Jul 31, 2012

Study Design

Enrollment
44 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Treat-and-extend
    Ranibizumab injection every 3 months, with follow-up assessments at each visit (every 3 months)
  • Experimental: Treat-and-observe'
    No injection, follow-up assessments every month

Primary Outcome Measure

Prevalence of CNVM recurrence [ Time Frame: 6 months ]

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