Use of Ranibizumab With Mitomycin C During Trabeculectomy

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT00661583
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ranibizumab — DRUG
    0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed
  • Ranibizumab and MMC — DRUG
    Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy
  • MMC — DRUG
    MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy.

Study Details

The purpose of the study is to study the safety of the combination of ranibizumab and MMC vs monotherapy MMC vs intravitreal ranibizumab injection in patients with glaucoma.

Key Dates

First listed
Apr 18, 2008
Start date
Apr 30, 2008
Status verified
Aug 2016
Primary completion
Sep 30, 2014
Completion
Sep 30, 2014

Study Design

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

Arms

  • Experimental: Ranibizumab alone
    Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)
  • Experimental: Ranibizumab and MMC
    Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)
  • Active Comparator: MMC alone
    MMC therapy alone (n=10)

Primary Outcome Measure

Assessment of Ocular Adverse Events [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rocky Mountain Lions Eye InstituteAuroraColorado80045-

Find similar trials in Aurora, CO

By condition
Glaucoma
By specialty
Ophthalmology
By research site
Rocky Mountain Lions Eye Institute· Aurora, CO

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