Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration

NCT00805233 | Completed Phase 2

• 2 other identifiers: FVF4442eIRB4543
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-Related Macular Degeneration

Keywords

Neovascular; AMD; Treatment; Lucentis; Bromfenac

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  every 3 months

Study Arms (2)

1

EXPERIMENTAL

Combination Ranibizumab intravitreal injection plus bromfenac ophthalmic drops

Drug: combination ranibizumab + bromfenac

2

ACTIVE COMPARATOR

ranibizumab injection alone.

Drug: ranibizumab injection alone

Interventions

combination ranibizumab + bromfenac 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.

1

ranibizumab injection alone DRUG

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

2

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Casey Eye Institute at Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

bromfenac; Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Peter J. Francis, MD, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: December 9, 2008
• Study Start: December 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 22, 2011

Record last verified: 2009-10

Locations

US (1)