Actively Recruiting
Observational Study of Disease Progression in Participants With Stargardt-type Macular Dystrophies
Led by Astellas Pharma Global Development, Inc. · Updated on 2026-05-28
90
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying Stargardt disease (STGD) and similar inherited eye conditions known as STGD-type macular dystrophies, which affect the macula, the central part of the retina responsible for sharp vision. These conditions cause central vision loss over time while mostly sparing side vision. The study aims to understand if the disease progresses similarly in people with STGD and those with related macular dystrophies caused by different genes. Genetic testing is the only way to confirm the specific condition. Participants with STGD or STGD-like macular dystrophies will continue their usual care with their own doctors. They will visit the clinic every 6 months for up to 2 years to undergo standard eye tests and imaging. Medical records and previous clinical data from the last 24 months will also be reviewed when available. No investigational treatments are given, as this is an observational study. During the study, participants will have their vision and eye structure assessed using tests like best corrected visual acuity (BCVA) and imaging. Researchers will collect information on participants' wellbeing, general health, medications, supplements, and daily activities. The main outcome measured is the change in BCVA over 12 months, with additional assessments at months 6, 18, and 24. Safety and disease progression will be monitored throughout the study period.
CONDITIONS
Brief Title
A Study to Learn How Stargardt-type Eye Conditions Progress in Children and Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has a documented clinical diagnosis of macular dystrophy with a Stargardt-type presentation confirmed by genetic testing
- Participant has clear eye media and pupils dilate adequately for imaging
- Intraocular pressure is 21 mmHg or less at screening and baseline
- Spherical equivalent refractive error between +8.00 D and -10.00 D, with exceptions for high myopia if no degenerative changes
- Best corrected visual acuity (BCVA) between 20/500 and 20/40
- Evidence of retinal pigment epithelium disease/damage on imaging
- Evidence of decreased autofluorescence on retinal imaging
- Ability and willingness to comply with study visits and assessments
- Capability to perform all required eye tests reliably
You will not qualify if you...
- History of significant systemic diseases that affect eye health or study assessments
- Autoimmune conditions requiring immunosuppressive therapy
- Diabetes with hemoglobin A1c of 7% or higher unless no diabetic complications
- Severe cardiac, cardiovascular, or cerebrovascular diseases within recent months
- Presence of other retinal or macular diseases that could affect study results
- Uncontrolled glaucoma or thyroid eye disease
- Diabetic retinopathy beyond mild stage
- History of uveitis or eye inflammation
- Corneal or lens opacities affecting imaging or eye tests
- Eye anatomy issues preventing pupil dilation
- Other ocular disorders interfering with vision or imaging
- Prior eye surgeries or treatments that could affect study participation
- Use of medications toxic to the eye or recent experimental treatments
- Recent major surgeries or planned surgeries during the study
- Known hypersensitivity to eye drops used in testing
- Any condition making the participant unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants with Stargardt-type eye conditions are observed over time to monitor disease progression through regular eye assessments.
Visits at baseline, and Months 6, 12, 18, and 24 with additional visits for early termination if needed
Trial Site Locations
Total: 7 locations
1
Associated Retina Consultants
Phoenix, Arizona, United States, 85020
Actively Recruiting
2
Stanford University School of Medicine
Palo Alto, California, United States, 94303
Actively Recruiting
3
University of California Health - UC Davis
Sacramento, California, United States, 95817
Actively Recruiting
4
Deep Blue Retina
Southaven, Mississippi, United States, 38671
Actively Recruiting
5
Duke Eye Center
Durham, North Carolina, United States, 27710
Actively Recruiting
6
Casey Eye Institute - Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
7
Retina Foundation of the Southwest
Dallas, Texas, United States, 75231
Actively Recruiting
Research Team
A
Astellas Pharma Global Development, Inc.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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