Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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 effective for treating wet AMD as compared to ranibizumab alone.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University
• Collaborator: Genentech, Inc.
• Treatments: Bromfenac; Ranibizumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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