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



Status:Recruiting
Conditions:Ocular, Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - 105
Updated:3/1/2019
Start Date:January 15, 2018
End Date:December 1, 2019
Contact:Xinxing Guo, MD, PhD
Email:xguo11@jhu.edu
Phone:4105029267

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

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.

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.

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
We found this trial at
1
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Baltimore, Maryland
Phone: 410-502-9267
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