A Study to Learn How Stargardt-type Eye Conditions Progress in Children and Adults

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Astellas Pharma Global Development, Inc.
Study ID
NCT07425574
Status
Recruiting
Apply to this trial

Conditions

  • Stargardt Disease
  • Stargardt Macular Dystrophy
  • Stargardt-like Macular Dystrophy

Eligibility Criteria

Sex
ALL
Age
6 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • No Intervention — OTHER
    No investigational drug will be administered to participants in this study.

Study Details

Macular dystrophies are a group of inherited eye conditions that affect the macula. The macula is in the center of the retina, the light sensitive part at the back of the eye. In people with macular dystrophies, some of the cells in the macula gradually stop working and may die over time. This leads to vision loss in the center of the eye. Side vision (peripheral vision) is mostly unaffected. Stargardt disease (STGD) is a type of macular dystrophy which is caused by 1 faulty gene (ABCA4). Vision loss most typically happens in childhood, but many people do not develop it until they are adults. As well as STGD, there are other macular dystrophies that look very similar to STGD but that are caused by many other different genes. Together, STGD and STGD-like conditions can be called STGD-type macular dystrophies. This is because they look the same clinically and have similar symptoms. Since different genes can cause these conditions, genetic testing is the only way to be sure which specific condition a person has. In this study, researchers want to learn if the disease progresses in a similar way in people with STGD and STGD-like macular dystrophies. People taking part in the study will continue to manage their condition, as agreed with their own doctor. People will visit their clinic every 6 months to have various standard eye tests and imaging. The information collected will include questions about people's wellbeing, general health, medication and supplements taken, and daily activities. Children over 6 years old and adults with STGD-type macular dystrophies may take part in this study. They will be in the study for up to 24 months (2 years). The study sponsor (Astellas) will not decide how people's condition is managed. However, the sponsor will provide instructions on when people visit their clinic and what is recorded during the study. If available, medical records, clinical and imaging data from previous visits going back 24 months will also be reviewed.

Key Dates

Start date
Feb 20, 2026
Status verified
May 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
90 participants (estimated)

Arms

  • Arm: Participants with Stargardt-type eye conditions
    Participants with STGD or STGD-like macular dystrophies.

Primary Outcome Measure

Change from baseline in best corrected visual acuity (BCVA) at month 12 [ Time Frame: Baseline and Month 12 ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Associated Retina ConsultantsPhoenixArizona85020-
Stanford University School of MedicinePalo AltoCalifornia94303-
University of California Health - UC DavisSacramentoCalifornia95817-
Deep Blue RetinaSouthavenMississippi38671-
Duke Eye CenterDurhamNorth Carolina27710-
Casey Eye Institute - Oregon Health & Science UniversityPortlandOregon97239-
Retina Foundation of the SouthwestDallasTexas75231-

Find similar trials in Phoenix, AZ

By research site
Associated Retina Consultants· Phoenix, AZStanford University School of Medicine· Palo Alto, CAUniversity of California Health - UC Davis· Sacramento, CADeep Blue Retina· Southaven, MSDuke Eye Center· Durham, NCCasey Eye Institute - Oregon Health & Science University· Portland, OR

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