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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 baseline

Change 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

Page last updated: August 20, 2015

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