Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration

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.

Study Overview

• Status: Completed
• Conditions: Age-Related Macular Degeneration
• Intervention / Treatment: Drug: combination ranibizumab + bromfenac; Drug: ranibizumab injection 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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Casey Eye Institute at Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; Combination Ranibizumab intravitreal injection plus bromfenac ophthalmic drops	Drug: 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.
ACTIVE_COMPARATOR: 2; ranibizumab injection alone.	Drug: ranibizumab injection alone; ranibizumab injection in study eye each month for 4 months then as needed each month for 8 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Mean change in visual acuity at 3, 6 and 12 months	every 3 months

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: Genentech, Inc.
• Investigators: Principal Investigator: Peter J. Francis, MD, PhD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (ACTUAL): September 1, 2010
• Study Completion (ACTUAL): September 1, 2010

Study Registration Dates

• First Submitted: December 8, 2008
• First Submitted That Met QC Criteria: December 8, 2008
• First Posted (ESTIMATE): December 9, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): July 22, 2011
• Last Update Submitted That Met QC Criteria: July 20, 2011
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: Treatment; AMD; Lucentis; Neovascular; Bromfenac
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab; Bromfenac
• Other Study ID Numbers: FVF4442; eIRB4543