Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration

NCT ID: NCT00805233

Last Updated: 2011-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2010-09-30

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.

Conditions

Age-Related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Combination Ranibizumab intravitreal injection plus bromfenac ophthalmic drops

Group Type: EXPERIMENTAL

combination ranibizumab + bromfenac

Intervention Type: DRUG

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.

2

ranibizumab injection alone.

Group Type: ACTIVE_COMPARATOR

ranibizumab injection alone

Intervention Type: DRUG

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

Interventions

combination ranibizumab + bromfenac

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.

Intervention Type: DRUG

ranibizumab injection alone

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Oregon Health & Science University

Principal Investigators

Peter J. Francis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Casey Eye Institute at Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

eIRB4543

Identifier Type: -

Identifier Source: secondary_id

FVF4442

Identifier Type: -

Identifier Source: org_study_id