NVAMD Satellite Study

Completed · Not applicable

Conditions studied: Neovascular Age Related Macular Degeneration

In brief

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.

Key facts

Study ID: NCT02251366
Run by: Johns Hopkins University
People needed: 66
Starts: 2014-10-01
Expected to finish: 2016-10-30
Last updated by the study team: 2018-08-31

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Established diagnosis of NVAMD in one or both eyes
Received 2 or more intravitreal injections of anti-VEGF therapy from the retinal physician during the prior 6 months
Need for more therapy on a near monthly basis is anticipated
Usual corrected visual acuity (UCVA) of at least one eye must be 20/200 or better
Must be physically able to cooperate with OCT and other diagnostic imaging procedures
Must be able to give informed consent and be able to complete telephone surveys

You may not qualify if…

Systemic disease that can affect the peripheral retina (e.g., diabetes mellitus, sickle cell)
History of symptomatic posterior vitreous detachment, retinal tear, or retinal detachment
History of retinal surgery will not be enrolled.

Where it is running

Wilmer Eye Institute — Bel Air, Maryland, United States
Wilmer Eye Institute — Bethesda, Maryland, United States
Wilmer Eye Institute — Columbia, Maryland, United States
Wilmer Eye Institute — Frederick, Maryland, United States
Wilmer Eye Institute — Lutherville, Maryland, United States

Full record on ClinicalTrials.gov

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