Neovascular Age-Related Macular Degeneration Clinical Trial
Official title:
Evaluation of Post Injection Inflammation and Pain After Ranibizumab vs Aflibercept Intravitreal Injections
This study is designed to compare the post injection inflammation and pain seen after intravitreal injections of Ranibizumab vs Aflibercept.
This is an open-label, Phase I-II study of post injection pain and inflammation after
intravitreally administered Ranibizumab and Aflibercept in 100 subjects with Neovascular
Age-Related Macular Degeneration. We will enroll both treatment experienced ( patients who
were treated with Lucentis or Eylea, but not Avastin in the past) and treatment naive
patients ( new onset Neovascular AMD with no history of intravitreal injections).
The treatment experienced patients will be treated with the intravitreal medication other
than what they were receiving in the past, for example, patients treated with Lucentis will
switch to Eylea for study purposes and vice versa.
Consented, enrolled subjects will receive open-label intravitreal injection of either 0.5mg
Ranibizumab or 2mg Aflibercept. A standard intravitreal injection protocol will be followed.
Patients will be reevaluated between 24-48 hours and 5-7 days post injections. A
non-injecting physician will evaluate the patients for anterior chamber inflammation; this
physician will be blinded about the specific treatment. Anterior chamber inflammation is
described as any cell or flare in the anterior chamber. These will be evaluated using
Standardization of Uveitis Nomenclature (SUN) working group classifications.
Pain score will be evaluated using a Numerical Rating Scale. Each patient will have a
standard script verbally read to them at their visit, and asked to rate their pain based on
this scale.
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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