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

Primary Purpose

Low Vision, Neovascular Age-related Macular Degeneration

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Vision rehabilitation

About this trial

This is an interventional treatment trial for Low Vision

Eligibility Criteria

50 Years - 105 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Wilmer Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Vision Rehabilitation Group 1

Vision Rehabilitation Group 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Consent rate

Consent rate of the approached participants

Secondary Outcome Measures

Retention rate

Retention rate of the enrolled participants

Breaking of randomization in group 2

Rate of participants crossing over to group 1 from group 2

Full Information

NCT ID

NCT03065907

First Posted

February 23, 2017

Last Updated

December 13, 2019

Sponsor

Johns Hopkins University

1. Study Identification

Unique Protocol Identification Number

NCT03065907

Brief Title

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

Acronym

TRAVIT

Official Title

Timing of Low Vision Rehabilitation in Anti-VEGF Therapy: a Randomized, Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

January 15, 2018 (Actual)

Primary Completion Date

September 1, 2018 (Actual)

Study Completion Date

December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Vision, Neovascular Age-related Macular Degeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vision Rehabilitation Group 1

Arm Type

Active Comparator

Arm Description

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

Arm Title

Vision Rehabilitation Group 2

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Vision rehabilitation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Consent rate

Description

Consent rate of the approached participants

Time Frame

2 months

Secondary Outcome Measure Information:

Title

Retention rate

Description

Retention rate of the enrolled participants

Time Frame

18 months

Title

Breaking of randomization in group 2

Description

Rate of participants crossing over to group 1 from group 2

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

105 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Judith Goldstein

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wilmer Eye Institute

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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