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Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00805233
Recruitment Status : Completed
First Posted : December 9, 2008
Last Update Posted : July 22, 2011
Genentech, Inc.
Information provided by:
Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Drug: combination ranibizumab + bromfenac Drug: ranibizumab injection alone Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration
Study Start Date : December 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  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 [ Time Frame: monthly ]

Secondary Outcome Measures :
  1. Mean change in visual acuity at 3, 6 and 12 months [ Time Frame: every 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00805233

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United States, Oregon
Casey Eye Institute at Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Genentech, Inc.
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Principal Investigator: Peter J. Francis, MD, PhD Oregon Health and Science University
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Responsible Party: Peter J. Francis, MD, PhD, Oregon Health & Science University Identifier: NCT00805233    
Other Study ID Numbers: FVF4442
First Posted: December 9, 2008    Key Record Dates
Last Update Posted: July 22, 2011
Last Verified: October 2009
Keywords provided by Oregon Health and Science University:
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents