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Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration

Primary Purpose

Age-Related Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
combination ranibizumab + bromfenac
ranibizumab injection alone
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring Neovascular, AMD, Treatment, Lucentis, Bromfenac

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Casey Eye Institute at Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Combination Ranibizumab intravitreal injection plus bromfenac ophthalmic drops

ranibizumab injection alone.

Outcomes

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

Secondary Outcome Measures

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

Full Information

First Posted
December 8, 2008
Last Updated
July 20, 2011
Sponsor
Oregon Health and Science University
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00805233
Brief Title
Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration
Official Title
Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Oregon Health and Science University
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
Keywords
Neovascular, AMD, Treatment, Lucentis, Bromfenac

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Combination Ranibizumab intravitreal injection plus bromfenac ophthalmic drops
Arm Title
2
Arm Type
Active Comparator
Arm Description
ranibizumab injection alone.
Intervention Type
Drug
Intervention Name(s)
combination ranibizumab + bromfenac
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
ranibizumab injection alone
Intervention Description
ranibizumab injection in study eye each month for 4 months then as needed each month for 8 months
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Mean change in visual acuity at 3, 6 and 12 months
Time Frame
every 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J. Francis, MD, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Casey Eye Institute at Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration

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