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

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ClinicalTrials.gov Identifier: NCT03065907
Recruitment Status : Recruiting
First Posted : February 28, 2017
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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
Low Vision Neovascular Age-related Macular Degeneration Other: Vision rehabilitation Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 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 : January 15, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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.




Primary Outcome Measures :
  1. Consent rate [ Time Frame: 2 months ]
    Consent rate of the approached participants


Secondary Outcome Measures :
  1. Retention rate [ Time Frame: 18 months ]
    Retention rate of the enrolled participants

  2. Breaking of randomization in group 2 [ Time Frame: 18 months ]
    Rate of participants crossing over to group 1 from group 2



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Ages Eligible for Study:   50 Years to 105 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03065907


Contacts
Contact: Xinxing Guo, MD, PhD 4105029267 xguo11@jhu.edu

Locations
United States, Maryland
Wilmer Eye Institute Recruiting
Baltimore, Maryland, United States, 21287
Contact: Xinxing Guo, MD, PhD    410-502-9267    xguo11@jhu.edu   
Sponsors and Collaborators
Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03065907     History of Changes
Other Study ID Numbers: IRB00095381
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Vision, Low
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Endothelial Growth Factors
Growth Substances
Physiological Effects of Drugs