Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration

Age-Related Macular Degeneration Clinical Trial

Official title:

Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00805233
• Other study ID #: FVF4442
• Secondary ID: eIRB4543
• Status: Completed
• Phase: Phase 2
• First received: December 8, 2008
• Last updated: July 20, 2011
• Start date: December 2008
• Est. completion date: September 2010

Study information

• Verified date: October 2009
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration
• Wet Macular Degeneration

Intervention

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

Locations

Country	Name	City	State
United States	Casey Eye Institute at Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Mean change in visual acuity at 3, 6 and 12 months		every 3 months	No