Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration

Phase 2

Completed

• Conditions: Age-Related Macular Degeneration
• Interventions: Drug: combination ranibizumab + bromfenac; Drug: ranibizumab injection alone

• Registration Number: NCT00805233
• Lead Sponsor: Oregon Health and Science University

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 effective for treating wet AMD as compared to ranibizumab alone.

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 monotherapy is currently the standard of care in neovascular AMD patients. Inflammation is believed to play an important role in AMD. Currently, MD's are investigating modulating the inflammation component of AMD with intra-ocular steroids although there is a high rate of steroid associated adverse events, such as glaucoma, cataracts and endophthalmitis.

Bromfenac is a non-steroidal anti-inflammatory drug (NSAIDS) and is currently approved for the treatment of inflammation following cataract surgery. In combination with intravitreal ranibizumab, bromfenac may also provide anti-inflammatory effects and may be a safer alternative to steroids.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-08
• Study First Submitted QC: 2008-12-08
• Study First Posted: 2008-12-09
• Status Verified: 2009-10
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Last Update Submitted: 2011-07-20
• Last Update Posted: 2011-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	combination ranibizumab + bromfenac	Combination Ranibizumab intravitreal injection plus bromfenac ophthalmic drops
2	ranibizumab injection alone	ranibizumab injection alone.

Primary Outcome Measures

Name	Time	Method
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	monthly

Secondary Outcome Measures

Name	Time	Method
Mean change in visual acuity at 3, 6 and 12 months	every 3 months

Trial Locations

Locations (1)

Casey Eye Institute at Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States