Age-Related Macular Degeneration Clinical Trial
Official title:
Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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