Clinical trial NCT03065907: Timing of Low Vision Rehabilitation in Anti- Vascular Endothelial Growth Factor (VEGF) Therapy
Official title: Timing of Low Vision Rehabilitation in Anti-VEGF Therapy: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Vision
Neovascular Age-related Macular Degeneration
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2017-02-28
Enrollment: 3
Sex: ALL
Minimum age (years): 50
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Consent rate
timeFrame: 2 months
Secondary outcomes:
measure: Retention rate
timeFrame: 18 months
measure: Breaking of randomization in group 2
timeFrame: 18 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Wilmer Eye Institute
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Judith Goldstein
role: PRINCIPAL_INVESTIGATOR
References: