NCT04591483|Recruiting
Stargardt-like Macular Dystrophy (STDG3) Secondary to Mutations in ELOVL4
An Observational Prospective Natural History Study of Stargardt-like Macular Dystrophy (STDG3) Secondary to Mutations in ELOVL4
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An Observational Prospective Natural History Study of Stargardt-like Macular Dystrophy (STDG3) Secondary to Mutations in ELOVL4
Sponsor study identifier
Secondary identifiers
observational
25
1 country
1
Study Start
April 19, 2022
Actual (reported)Primary Completion
July 16, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 16, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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....
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 16, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 16, 2020
Actual (reported)October 19, 2020
Actual (reported)April 19, 2022
Actual (reported)July 16, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 16, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Growth rate in square root area of loss of the inner segment/outer segment band (EZband)
The growth rate of the square root area of loss of the inner segment/outer segment band (EZband) obtained from SD-OCT.
Day 1, 182, 364, 728, 1,092
Growth rate of square root area of atrophy measured from short-wavelength autofluorescence
The rate of atrophy enlargement obtained from fundus autofluorescence.
Day 1, 182, 364, 728, 1,092
The change in BCVA total letters read from baseline to Year 3
Day 1, 182, 364, 728, 1,092
The rate of loss of retinal sensitivity measured with perimetry
Day 1, 182, 364, 728, 1,092
Patients with Stargardt-like macular dystrophy 3 who are \>= 10 years of age.
25 patients with Stargardt-like macular dystrophy 3 who are \>= 10 years of age.
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Brett G Jeffrey, Ph.D.
National Eye Institute (NEI)
First Submitted
October 16, 2020
First Posted
October 19, 2020
Study Start
April 19, 2022
Actual (reported)Primary Completion
July 16, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Study Completion
July 16, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 17, 2026
Record last verified: 2026-09-15
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Source: ClinicalTrials.gov.
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