Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT00805233
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • combination ranibizumab + bromfenac — DRUG
    ranibizumab injection in study eye each month for 4 months then as needed each month for 8 months. Plus one drop of bromfenac in the study eye twice per day, each day, for 12 months.
  • ranibizumab injection alone — DRUG
    ranibizumab injection in study eye each month for 4 months then as needed each month for 8 months

Study Details

This open-label, randomized, Phase II research study will look to see whether an investigational treatment combining bromfenac ophthalmic drops with ranibizumab intravitreal injection is safe and effective for treating wet AMD as compared to ranibizumab alone.

Key Dates

First listed
Dec 9, 2008
Start date
Dec 31, 2008
Status verified
Oct 2009
Primary completion
Sep 30, 2010
Completion
Sep 30, 2010

Study Design

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

Arms

  • Experimental: 1
    Combination Ranibizumab intravitreal injection plus bromfenac ophthalmic drops
  • Active Comparator: 2
    ranibizumab injection alone.

Primary Outcome Measure

Assessment of ocular adverse events, including uncontrolled inflammation, endophthalmitis, and retinal tear/detachment, abnormal sensation in eye, conjunctival hyperemia, eye irritation, eye pain, eye pruritus, eye redness, headache, and iritis [ Time Frame: monthly ]

Locations (1)

FacilityCityStateZIPSite coordinators
Casey Eye Institute at Oregon Health & Science UniversityPortlandOregon97239-

Find similar trials in Portland, OR

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
Casey Eye Institute at Oregon Health & Science University· Portland, OR

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