Low VisionTRAVITNCT03065907
Timing of Low Vision Rehabilitation in Anti- Vascular Endothelial Growth Factor (VEGF) Therapy
A study testing Vision rehabilitation in people with Low Vision and Neovascular Age-related Macular Degeneration, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 105 years
- Conditions the study is for
- Low Vision, Neovascular Age-related Macular Degeneration
- What is being tested?
- Vision rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2018to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Vision rehabilitation
- Medical subject headings
- Vision, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vision rehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Vision Rehabilitation Group 1 | Active comparator | Vision rehabilitation assessment will be scheduled within 1 months of randomization; interventions will be scheduled and vision rehabilitation appointments will be scheduled accordingly. Receives: Other: Vision rehabilitation |
| Vision Rehabilitation Group 2 | Active comparator | Vision rehabilitation assessment will be scheduled within 7 months of randomization; interventions will be scheduled and vision rehabilitation appointments will be scheduled accordingly. Receives: Other: Vision rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consent rate
Consent rate of the approached participants
Measured: 2 months
Secondary outcomes (2)
Retention rate
Retention rate of the enrolled participants
Measured: 18 months
Breaking of randomization in group 2
Rate of participants crossing over to group 1 from group 2
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start15 Jan 2018
- Primary completion1 Sep 2018
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low VisionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judith Goldstein, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065907
- Sponsor's protocol ID
- IRB00141001
- Acronym
- TRAVIT
- Status last verified
- Dec 2019
- First submitted
- 23 Feb 2017
- Last updated
- 16 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Low Vision Rehabilitation in Anti-VEGF Therapy: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03065907
- Acronym / sponsor ID
- TRAVIT / IRB00141001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 28 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vision Rehabilitation Group 1 | Active comparator | Other: Vision rehabilitationVision rehabilitation assessment will be scheduled within 1 months of randomization; interventions will be scheduled and vision rehabilitation appointments will be scheduled accordingly. |
| Vision Rehabilitation Group 2 | Active comparator | Other: Vision rehabilitationVision rehabilitation assessment will be scheduled within 7 months of randomization; interventions will be scheduled and vision rehabilitation appointments will be scheduled accordingly. |
Who may qualify
- Ages
- 50 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vision rehabilitationA 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. | Other | Vision Rehabilitation Group 1, Vision Rehabilitation Group 2 |
Primary outcome
Consent rate
Time frame: 2 months
Consent rate of the approached participants
2 secondary outcomes
Retention rate
Time frame: 18 months
Breaking of randomization in group 2
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith Goldstein principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vision rehabilitation in people with Low Vision and Neovascular Age-related Macular Degeneration, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consent rate (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019.