Timing of Low Vision Rehabilitation in Anti- Vascular Endothelial Growth Factor (VEGF) Therapy

NCT03065907 | Completed

• 1 other identifier: IRB00141001
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to collect preliminary data in preparation for conducting a randomized clinical trial to determine the relative effectiveness of vision rehabilitation in improving overall visual ability (primary aim) and reducing depression (secondary aim) in patients receiving anti-VEGF therapy for neovascular age-related macular degeneration integrated over time.

Conditions

Low Vision; Neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Consent rate

  Consent rate of the approached participants

  2 months

Secondary Outcomes (2)

• Retention rate

  18 months

• Breaking of randomization in group 2

  18 months

Study Arms (2)

Vision Rehabilitation Group 1

ACTIVE COMPARATOR

Vision rehabilitation assessment will be scheduled within 1 months of randomization; interventions will be scheduled and vision rehabilitation appointments will be scheduled accordingly.

Other: Vision rehabilitation

Vision Rehabilitation Group 2

ACTIVE COMPARATOR

Vision rehabilitation assessment will be scheduled within 7 months of randomization; interventions will be scheduled and vision rehabilitation appointments will be scheduled accordingly.

Other: Vision rehabilitation

Interventions

Vision rehabilitation OTHER

A service menu containing the minimum vision rehabilitation visits will be provided and assessed according to the participant's vision needs. Minimum vision rehabilitation visits include refraction, best-corrected visual acuity assessment, near vision, contrast sensitivity, central visual field test, education and consultation; rehabilitation visit will then be individualized.

Vision Rehabilitation Group 1; Vision Rehabilitation Group 2

Eligibility Criteria

• Age: 50 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 50 years old
• Primary diagnosis of neovascular age-related macular degeneration in the index eye or in both eyes if habitual visual acuity (HVA) is equivalent in both eyes
• HVA \< 20/25 to ≥ 20/500 in the index eye
• Confirmed active anti-VEGF injections (a minimum of 2 injections in the past 3 months, a total of 8 injections maximum) in the index eye
• Full confrontational visual fields in the index eye
• Acknowledgement of having difficulty in visual ability function
• Visual ability estimates as measured by ≥ 2 goals identified on the Activity Inventory as important and with at least slight difficulty
• Telephone interview for cognitive status raw score is \> 29
• Ability to return to clinic to participate in rehabilitation
• No prior experience with vision rehabilitation service

You may not qualify if:

• Other progressive ocular conditions likely to compromise VA during the study period or upcoming eye surgeries
• Anti-VEGF injections in the index eye 8 months prior to enrollment
• Unable to give written consent to the study
• Impaired hearing or cognitive ability that precludes telephone interviews
• Insufficient spoken English or reading ability to complete interviews and understand study materials
• The index eye is defined as the eye with better HVA, or the eye with more anti-VEGF injections if both eyes are with the equivalent HVA

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Vision, Low

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Judith Goldstein

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: February 28, 2017
• Study Start: January 15, 2018
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2019
• Last Updated: December 16, 2019

Record last verified: 2019-12

Locations

US (1)