Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration

Oregon Health & Science University (OHSU)

Status and phase

Completed

Phase 2

Conditions

Age-Related Macular Degeneration

Treatments

Drug: ranibizumab injection alone

Drug: combination ranibizumab + bromfenac

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00805233

FVF4442

eIRB4543

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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