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NCT04591483 · ClinicalTrials.gov registry record
Stargardt-like Macular Dystrophy (STDG3) Secondary to Mutations in ELOVL4
A clinical trial of Stargardt-like Macular Dystrophy, sponsored by National Eye Institute (NEI).
- Recruiting
- Registry status
- 25
- Enrollment target
- 1
- Study location
NCT04591483: Recruiting study of Stargardt-like Macular Dystrophy, sponsored by National Eye Institute (NEI).
NCT04591483 is a study of Stargardt-like Macular Dystrophy that is actively recruiting participants, run by National Eye Institute (NEI). The registered enrollment target is 25 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04591483, a study of Stargardt-like Macular Dystrophy, is actively recruiting participants, sponsored by National Eye Institute (NEI).
- RECRUITING
- Registry status
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: STDG3 is an inherited eye disease. Currently there is no treatment for STDG3. Past studies of STDG3 have largely looked at members of large families at a single time point. Researchers want to learn more about the disease at an individual level. Objective: To understand the natural history of changes in the retina that occur in people with STDG3. Eligibility: People ages 10 and older with STDG3 due to a variant in the ELOVL4 gene. Design: Participants will have 6 visits. First they will have a screening visit, followed by a baseline visit. Then they will have a visit 6 months later. Then they will have a visit 1, 2, and 3 years after the first visit. Visits will last 4 to 8 hours. Visits will include the following: Medical history and physical exam. Complete eye exam. Participants' eye pressure and ability to see letters on a vision chart will be tested. Their pupils will be dilated with eye drops. Pictures will be taken of the retina and the inside of the eye. Questions about participants' family history, especially the presence of eye disease. Visual field test. Participants will be seated in front of a large dome and asked to press a button when they see a light within the dome. Electroretinogram. Participants will sit in the dark with their eyes patched for 30 minutes. Then they will wear special contact lenses and watch flashing lights. Optical coherence tomography. Cross-sectional pictures will be taken of participants' retinas. Fundus autofluorescence. Blue light will be shone into participants eyes to assess the health of the retina....
Primary Outcome
The growth rate of the square root area of loss of the inner segment/outer segment band (EZband) obtained from SD-OCT.
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2022-04-19 |
| Est. Completion | 2028-07-16 |
What NCT04591483 shows while recruiting
NCT04591483 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 25 participants, a relatively small participant target.
The record links to 1 condition, with Stargardt-like Macular Dystrophy appearing as the primary indexed condition, and to 0 interventions.
NCT04591483 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04591483 about?
NCT04591483 is a clinical study titled "Stargardt-like Macular Dystrophy (STDG3) Secondary to Mutations in ELOVL4". Background: STDG3 is an inherited eye disease. Currently there is no treatment for STDG3. Past studies of STDG3 have largely looked at members of large families at a single time point. Researchers want to learn more about the disease at an individual level. Objective: To understand the natural hi...
What is the current status of trial NCT04591483?
This trial is currently recruiting. The enrollment target is 25 participants. The study started on 2022-04-19. Estimated completion is 2028-07-16.
What conditions does trial NCT04591483 study?
This clinical trial studies the following conditions: Stargardt-like Macular Dystrophy.
Who is sponsoring clinical trial NCT04591483?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04591483 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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