NVAMD Satellite Study

Neovascular Age Related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02251366
• Other study ID #: NA_00088759
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: October 30, 2016

Study information

• Verified date: August 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 30, 2016
• Est. primary completion date: October 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion criteria:

• 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

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age Related Macular Degeneration
• Wet Macular Degeneration

Intervention

Procedure:
• Physician-guided diagnostic
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.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of intravitreal anti-VEGF injections administered		up to two years
Other	number of diagnostic tests performed		up to two years
Other	number of retinal examinations performed		up to two years
Primary	Change in visual acuity from baseline		up to two years
Primary	Change in OCT CSF from baseline		up to two years
Secondary	total encounter time for each arm		up to two years