Evaluation of Dosing Interval of Higher Doses of Ranibizumab

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Brandon G. Busbee, MD
Study ID
NCT00533520
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 95 Years
Healthy Volunteers
Accepted

Interventions

  • ranibizumab — DRUG
    Arm A: 0.5 mg ranibizumab on day 0 with retreatment based on defined criteria not to occur sooner than every 28 days Arm B: 1.0 mg ranibizumab on day 0 with retreatment based on defined criteria not to occur sooner than every 28 days Third Arm 2.0mg Arm with retreatment based on defined criteria not to occur sooner than every 28 days

Study Details

Evaluation of Dosing Interval of Higher Doses of Ranibizumab for patients with wet age-related macular degeneration (AMD).

Key Dates

First listed
Sep 21, 2007
Start date
Sep 30, 2007
Status verified
Nov 2013
Primary completion
Nov 30, 2013
Completion
Nov 30, 2013

Study Design

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

Arms

  • Active Comparator: 0.5mg ranibizumab
    Subjects will be treated with 0.5mg ranibizumab at the Day 0 visit and the as needed based on defined retreatment criteria no sooner than every 28 days since last treatment.
  • Active Comparator: 1.0mg ranibizumab
    Subjects will be treated with 1.0mg ranibizumab at the Day 0 visit and the as needed based on defined retreatment criteria no sooner than every 28 days since last treatment.
  • Active Comparator: 2.0mg ranibizumab
    Subjects will be treated with 2.0 mg ranibizumab at the Day 0 visit and the as needed based on defined retreatment criteria no sooner than every 28 days since last treatment.

Primary Outcome Measure

Safety - Presence of intraocular inflammation following intravitreal ranibizumab injection [ Time Frame: 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Tennessee Retina, P.C.NashvilleTennessee37203-

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