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

NCT ID: NCT03065907

Last Updated: 2019-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-15
• Study Completion Date: 2019-12-01

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.

Detailed Description

This is a pilot study to understand the feasibility of conducting a randomized, controlled trial regarding the timing for vision rehabilitation in patients receiving anti-VEGF therapy for neovascular age-related macular degeneration. Prior to initiating the clinical trial, the investigators must be assured that patients with loss in visual ability are willing to be randomized and amenable to deferring vision rehabilitation intervention. Although it is typical for patients receiving usual care to present for vision rehabilitation services years after the onset of anti-VEGF therapy, this manifestation may result from patients being unaware of the existence of vision rehabilitation services to enhance function and reduce depression. As part of the study recruitment, patients will be informed about vision rehabilitation care and, if suffering with difficulty performing everyday activities, they may be unwilling to defer vision rehabilitation. Additionally, the study design may not be feasible to answer the aim should patients in the delayed intervention arms suffer progressive loss in visual ability and seek vision rehabilitation services, resulting in a high drop-out rate.

Conditions

Low Vision; Neovascular Age-related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Vision Rehabilitation Group 1

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

Group Type: ACTIVE_COMPARATOR

Vision rehabilitation

Intervention Type: 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 2

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

Group Type: ACTIVE_COMPARATOR

Vision rehabilitation

Intervention Type: 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.

Interventions

Vision rehabilitation

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 105 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judith Goldstein

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Wilmer Eye Institute

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00141001

Identifier Type: -

Identifier Source: org_study_id