Purpose of this Study
We are doing this study to gather information on Stargardt Disease Type 1 (STGD1) and how it develops over time.
Who Can Participate?
Eligibility
Children and adults ages 12-65 who:<ul>
<li>Are diagnosed with STGD1</li>
<li>Have no other eye disease, like cataracts, that would affect the procedures</li>
<li>Have no history of amblyopia (lazy eyes)</li></ul>
For more information about who can be in this study, please contact the study team at <a href= "mailto: DEC-RA@duke.edu">DEC-RA@duke.edu</a> or 919-660-3520.
<li>Are diagnosed with STGD1</li>
<li>Have no other eye disease, like cataracts, that would affect the procedures</li>
<li>Have no history of amblyopia (lazy eyes)</li></ul>
For more information about who can be in this study, please contact the study team at <a href= "mailto: DEC-RA@duke.edu">DEC-RA@duke.edu</a> or 919-660-3520.
Age Range
12-65
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you choose to join this observational study, you will:<ul>
<li>Keep in touch with the study team for about 96 weeks (8 years)</li>
<li>Visit our clinic at the Duke Eye Center up to 6 times</li></ul>
At various visits, you will answer some questionnaires, and have eye exams and vision tests.
<li>Keep in touch with the study team for about 96 weeks (8 years)</li>
<li>Visit our clinic at the Duke Eye Center up to 6 times</li></ul>
At various visits, you will answer some questionnaires, and have eye exams and vision tests.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
An Observational Study in Subjects to Follow the Progression of Stargardt Disease Type 1 (STGD1) Caused by Bi-Allelic Autosomal Recessive Mutations in the ATP Binding Cassette Subfamily A Member 4 (ABCA4) Gene - POLARIS
Principal Investigator
Ramiro
Maldonado
Protocol Number
PRO00115342
NCT ID
NCT06435000
Phase
N/A
Enrollment Status
Open to Enrollment