NVAMD Satellite Study

Intravitreal delivery of anti-vascular endothelial growth factor (VEGF) drugs has
revolutionized the management of neovascular age-related macular degeneration (NVAMD).
However, the requirement for near monthly administration of therapy coupled with the growing
number of patients needing treatment has become a universal challenge in efficient delivery
of care for retina physicians. While many retina practices have both increased the size of
their staffs to accommodate the growing patient population and increased efficiency with the
aid of digital photography, patient encounter times in clinic continue to increase, often
spanning 2-4 hours. While maintaining the highest level of patient care, a streamlined
alternative in the evaluation of patients with NVAMD to determine whether intravitreal
therapy with an anti-VEGF agent is indicated at a particular office visit would be desirable.

This multi-satellite, prospective, randomized pilot study will compare standard-of-care,
physician- based retinal evaluation, defined as retinal examination by a physician and
standard imaging with optical coherence tomography (OCT) and optional fluorescein angiography
(FA), versus physician-guided diagnostic evaluation, defined as standard imaging with OCT and
optional FA without retinal examination by a physician in the management of NVAMD with
anti-VEGF therapy. Outcomes for this study are aimed primarily at demonstrating that the
physician-guided diagnostic approach to managing patients with NVAMD is not inferior to the
physician-based retinal evaluation based on measures such as a change from baseline in visual
acuity and in central subfield thickness (CSF) on OCT. Other outcomes to be assessed in this
study are length of visit times, numbers of intravitreal injections of anti-VEGF agents
administered, numbers of diagnostic tests performed to determine whether treatment should be
given at each visit, and frequency of retinal examinations performed for each participating
patient in each cohort. Perceptions of quality of vision and patient satisfaction will be
captured by interviews with patients following each clinic visit; clinical impressions of
physicians will be captured by a brief physician survey. Finally, the feasibility of
recruiting patients, as measured by how many eligible patients are seen at each Wilmer
satellite, how many patients agree to be randomized, how many patients follow-up, and the
attrition rates at the 4 and 8-month outcome visits will be assessed.