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OpenTrials
Completed

NCT Number: NCT00805233

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.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Casey Eye Institute at Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

ranibizumab injection alone

Drug

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

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

    Time frame: monthly

Secondary outcomes

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

    Time frame: every 3 months

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Genentech, Inc.

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 9, 2008
Registry last updated
Jul 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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