Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00805233
First received: December 8, 2008
Last updated: July 20, 2011
Last verified: October 2009
  Purpose

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 Intervention Phase
Age-Related Macular Degeneration
Drug: combination ranibizumab + bromfenac
Drug: ranibizumab injection alone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean change in visual acuity at 3, 6 and 12 months [ Time Frame: every 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805233

Locations
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
Investigators
Principal Investigator: Peter J. Francis, MD, PhD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Peter J. Francis, MD, PhD, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT00805233     History of Changes
Other Study ID Numbers: FVF4442, eIRB4543
Study First Received: December 8, 2008
Last Updated: July 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Oregon Health and Science University:
Neovascular
AMD
Treatment
Lucentis
Bromfenac

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bromfenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 01, 2014