A Phase 2 interventional study of combination ranibizumab + bromfenac and ranibizumab injection alone in Age-Related Macular Degeneration, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2011-07-22.
Sponsored by Oregon Health and Science University · Phase 2, Interventional, and Treatment
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.
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.
1,490 studies on the registry are indexed under Macular Degeneration; 208 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 993 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Oregon Health and Science University is the lead sponsor of 694 studies on the registry; 133 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 39 (76%) have results posted.
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Exclusion Criteria:
Combination Ranibizumab intravitreal injection plus bromfenac ophthalmic drops
Drug: combination ranibizumab + bromfenac
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. Plus one drop of bromfenac in the study eye twice per day, each day, for 12 months.
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
This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.
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