Status:
COMPLETED
Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Age-Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
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 effe...
Detailed Description
Age Related Macular Degeneration (AMD) is the leading cause of blindness in adults over the age of 50 years. It can cause permanent loss of eyesight due to deterioration of the macula. Ranibizumab mo...
Eligibility Criteria
Inclusion
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age \> 50 years
- Patients with active neovascular AMD
- If the patient has bilateral disease and qualifies for the study, both eyes may be included
Exclusion
- Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception.
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Current or recent participation in another simultaneous investigational drug trial may be exclusionary at the investigator's discretion
- Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma)
- Previous intravitreal steroid or anti-VEGF therapy within last 3 months.
- Patients with a concurrent corneal epithelial disruption or erosion
- Patients with immune deficiencies that would affect the ability of the cornea to heal
- Patients with a known sensitivity to any component of the formulations under investigation
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00805233
Start Date
December 1 2008
End Date
September 1 2010
Last Update
July 22 2011
Active Locations (1)
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1
Casey Eye Institute at Oregon Health & Science University
Portland, Oregon, United States, 97239