Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration
|ClinicalTrials.gov Identifier: NCT00805233|
Recruitment Status : Completed
First Posted : December 9, 2008
Last Update Posted : July 22, 2011
|Condition or disease||Intervention/treatment||Phase|
|Age-Related Macular Degeneration||Drug: combination ranibizumab + bromfenac Drug: ranibizumab injection alone||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration|
|Study Start Date :||December 2008|
|Primary Completion Date :||September 2010|
|Study Completion Date :||September 2010|
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
- 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 ]
- Mean change in visual acuity at 3, 6 and 12 months [ Time Frame: every 3 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00805233
|United States, Oregon|
|Casey Eye Institute at Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Peter J. Francis, MD, PhD||Oregon Health and Science University|