Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration

Study Overview
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Brief Summary
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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
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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.

Official Title
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Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration

Conditions
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Age-Related Macular Degeneration

Intervention / Treatment
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* Drug: combination ranibizumab + bromfenac
* Drug: ranibizumab injection alone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Combination Ranibizumab intravitreal injection plus bromfenac ophthalmic drops | Drug: combination ranibizumab + bromfenac<br>* 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.<br>|
| Active Comparator: 2<br>ranibizumab injection alone. | Drug: ranibizumab injection alone<br>* ranibizumab injection in study eye each month for 4 months then as needed each month for 8 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in visual acuity at 3, 6 and 12 months |  | every 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neovascular, AMD, Treatment, Lucentis, Bromfenac