NVAMD Satellite Study
- Conditions
- Neovascular Age Related Macular Degeneration
- Interventions
- Procedure: Physician-guided diagnostic
- Registration Number
- NCT02251366
- Lead Sponsor
- Johns Hopkins University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Physician-Guided Diagnostic Physician-guided diagnostic Participants in this arm of the study will only receive the physical standard-of-care retinal examination at the 4-month and -month office visits, unless requested by the Physician-Investigator or study participant. At each standard study visit, the physician will use diagnostic imaging to determine if the participant will receive the anti-VEGF injection.
- Primary Outcome Measures
Name Time Method Change in visual acuity from baseline up to two years Change in OCT CSF from baseline up to two years
- Secondary Outcome Measures
Name Time Method total encounter time for each arm up to two years
Trial Locations
- Locations (1)
Wilmer Eye Institute
🇺🇸Lutherville, Maryland, United States