Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration
Completed · Phase 2
Conditions studied: Age-Related Macular Degeneration
In brief
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 facts
- Study ID
- NCT00805233
- Run by
- Oregon Health and Science University
- People needed
- 30
- Starts
- 2008-12-01
- Expected to finish
- 2010-09-01
- Last updated by the study team
- 2011-07-22
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Casey Eye Institute at Oregon Health & Science University — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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