POLARIS (Stargardt Disease Type 1)

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:
  • Are diagnosed with STGD1
  • Have no other eye disease, like cataracts, that would affect the procedures
  • Have no history of amblyopia (lazy eyes)
For more information about who can be in this study, please contact the study team at DEC-RA@duke.edu 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?

Description

If you choose to join this observational study, you will:
  • Keep in touch with the study team for about 96 weeks (8 years)
  • Visit our clinic at the Duke Eye Center up to 6 times
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
ClinicalTrials.gov