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

Sponsor
Johns Hopkins University (Other)
Overall Status
Completed
CT.gov ID
NCT03065907
Collaborator
(none)
3
1
2
22.5
0.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Vision rehabilitation
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Timing of Low Vision Rehabilitation in Anti-VEGF Therapy: a Randomized, Controlled Trial
Actual Study Start Date :
Jan 15, 2018
Actual Primary Completion Date :
Sep 1, 2018
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Other: 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.

Active Comparator: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Consent rate [2 months]

    Consent rate of the approached participants

Secondary Outcome Measures

  1. Retention rate [18 months]

    Retention rate of the enrolled participants

  2. Breaking of randomization in group 2 [18 months]

    Rate of participants crossing over to group 1 from group 2

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 105 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wilmer Eye Institute Baltimore Maryland United States 21287

Sponsors and Collaborators

  • Johns Hopkins University

Investigators

  • Principal Investigator: Judith Goldstein, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT03065907
Other Study ID Numbers:
  • IRB00141001
First Posted:
Feb 28, 2017
Last Update Posted:
Dec 16, 2019
Last Verified:
Dec 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 16, 2019