Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration

Oregon Health and Science University30 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Age-Related Macular Degeneration

Interventions

combination ranibizumab + bromfenacDRUG

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 aloneDRUG

ranibizumab injection in study eye each month for 4 months then as needed each month for 8 months

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Casey Eye Institute at Oregon Health & Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

Mean change in visual acuity at 3, 6 and 12 months

Time frame: every 3 months

Data from ClinicalTrials.gov

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