NVAMD Satellite Study
Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neovascular Age Related Macular Degeneration
Intervention: Physician-guided diagnostic (Procedure)
Phase: N/A
Status: Recruiting
Sponsored by: Johns Hopkins University Official(s) and/or principal investigator(s): Sharon Solomon, MD, Principal Investigator, Affiliation: Johns Hopkins University
Overall contact: Sharon Solomon, MD, Phone: 410-614-6908, Email: ssolomon1@jhmi.edu
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.
Clinical Details
Official title: A Multi-Satellite Comparison of Standard-of-Care, Physician-Based Retinal Evaluation Versus Physician-Guided Diagnostic Evaluation in the Management of Neovascular Age-Related Macular Degeneration With Anti-Vascular Endothelial Growth Factor Therapy
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
Primary outcome: Change in visual acuity from baselineChange in OCT CSF from baseline
Secondary outcome: total encounter time for each arm
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion criteria:
- Established diagnosis of NVAMD in one or both eyes
- Received 3 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 20/100 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
Exclusion criteria:
- 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.
Locations and Contacts
Sharon Solomon, MD, Phone: 410-614-6908, Email: ssolomon1@jhmi.edu
Wilmer Eye Institute, Bel Air, Maryland 21014, United States; Not yet recruiting Adrienne Scott, MD, Phone: 410-502-9247, Email: ascott28@jhmi.edu Adrienne Scott, MD, Principal Investigator
Wilmer Eye Institute, Bethesda, Maryland 20814, United States; Recruiting Adam Wenick, MD, PhD, Phone: 410-955-5650, Email: awenick1@jhmi.edu Adam Wenick, MD,PhD, Principal Investigator
Wilmer Eye Institute, Columbia, Maryland 21044, United States; Not yet recruiting Akrit Sodhi, MD, PhD, Phone: 410-955-3518, Email: asodhi1@jhmi.edu Akrit Sodhi, MD, PhD, Principal Investigator
Wilmer Eye Institute, Frederick, Maryland 21702, United States; Not yet recruiting Ingrid Zimmer Galler, MD, Phone: 410-955-2159, Email: izimmerg@jhmi.edu Ingrid Zimmer Galler, MD, Principal Investigator
Wilmer Eye Institute, Lutherville, Maryland 21093, United States; Recruiting Sharon Solomon, MD, Phone: 410-614-6908, Email: ssolomon1@jhmi.edu Sharon Solomon, MD, Principal Investigator
Additional Information
Starting date: October 2014
Last updated: May 13, 2015
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