NVAMD Satellite Study
Condition: Neovascular Age Related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): Physician-guided diagnostic
Intervention type(s): Procedure
Intervention description(s): NVAMD participants in the physician-guided diagnostic arm will have receive injections based on diagnostic imaging provided by optical coherence tomography and optional fluorescein angiography, those in this group will only receive retinal examinations at the 4- and 8-month clinic visits.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Age-Related Macular Degeneration