NVAMD Satellite Study

NCT02251366 | Completed DMC

• 1 other identifier: NA_00088759
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 5

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.

Conditions

Neovascular Age Related Macular Degeneration

Keywords

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

• Change in visual acuity from baseline

  up to two years

• Change in OCT CSF from baseline

  up to two years

Secondary Outcomes (1)

• total encounter time for each arm

  up to two years

Other Outcomes (3)

• Number of intravitreal anti-VEGF injections administered

  up to two years

• number of diagnostic tests performed

  up to two years

• number of retinal examinations performed

  up to two years

Study Arms (2)

SOC Examination Based Cohort

NO INTERVENTION

Participants in this arm will receive standard of care (SOC) retinal examinations at each study visit.

Physician-Guided Diagnostic

ACTIVE COMPARATOR

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.

Procedure: Physician-guided diagnostic

Interventions

Physician-guided diagnostic PROCEDURE

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.

Physician-Guided Diagnostic

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (5)

Wilmer Eye Institute

Bel Air, Maryland, 21014, United States

Location

Wilmer Eye Institute

Bethesda, Maryland, 20814, United States

Location

Wilmer Eye Institute

Columbia, Maryland, 21044, United States

Location

Wilmer Eye Institute

Frederick, Maryland, 21702, United States

Location

Wilmer Eye Institute

Lutherville, Maryland, 21093, United States

Location

Related Publications (1)

• Solomon SD, Kyerematen V, Qutab M, Wenick AS, Wang J, Hawkins BS. Are Dilated Fundus Examinations Needed for OCT-Guided Retreatment of Exudative Age-Related Macular Degeneration? A Prospective, Randomized, Pilot Study. Clin Ophthalmol. 2021 Aug 12;15:3401-3417. doi: 10.2147/OPTH.S315554. eCollection 2021.

  PMID: 34408396 DERIVED

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Sharon Solomon, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 29, 2014
• Study Start: October 1, 2014
• Primary Completion: October 30, 2016
• Study Completion: October 30, 2016
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

US (5)