RecruitingNot a traditional drug phaseobservationalRules rewrite

Not a traditional drug phase: No Intervention for Stargardt Disease

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.

Official registry: https://clinicaltrials.gov/study/NCT07425574 · Astellas Pharma Global Development, Inc. · enrollment listed as 90

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 90 people at 15 sites. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

An Observational Study of Natural Disease Progression in Participants With Macular Dystrophies Expressing a Stargardt-type Clinical Presentation

Interventions: No Intervention

Primary outcome (registry wording): Change from baseline in best corrected visual acuity (BCVA) at month 12

Who it is for (from inclusion criteria)

Ages 6 Years to any
Participant has a documented clinical diagnosis of macular dystrophy expressing a STGD-type clinical presentation and molecular confirmation, defined as either:
ABCA4-associated disease: presence of biallelic (pathogenic or likely pathogenic) ABCA4 variants, or one definite disease-causing ABCA4 variant together with a typical phenotype consistent with STGD
Participant has sufficiently clear ocular media and adequate pupillary dilation to allow for all imaging procedures
Participant has intraocular pressure (IOP) both at screening and baseline of ≤ 21 mmHg measured by applanation tonometry. Note: Participant who is on topical IOP lowering treatment may also be included
Participant has a spherical equivalent refractive error between + 8.00 D and - 10.00 D. Eyes with high myopia (\> -10.00 D) are permitted only if there are no signs of myopic degenerative macular changes
Participant has a BCVA ranging from 20/500 to 20/40 (equivalent to 15 to 70 ETDRS letters read at 1 meter)
Participant has evidence of retinal pigment epithelium (RPE) disease/damage on SD-OCT (hypertransmission defects \[HTDs\]) and/or FAF imaging

Who the registry excludes

Participant has an autoimmune condition that requires treatment with immunomodulatory therapy and/or biologics that cause immunosuppression
Participant has a known history of any systemic or metabolic condition, or physical examination finding that may significantly affect ocular health or interfere with the interpretation of study assessments
Participant has a history or evidence of severe cardiac disease (e.g., New York Heart Association Functional Class III or IV), clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within 6 months prior to screening
Participant has a history or evidence of ventricular tachyarrhythmia requiring ongoing treatment
Participant has a significant cardiovascular or cerebrovascular disease, including a history of stroke within 12 months prior to screening
Participant has evidence or history of choroidal neovascularization
Participant has macular atrophy due to any cause other than a genetically or clinically confirmed diagnosis of STGD or STGD-like macular dystrophies

Public study contact (from the registry)

Astellas Pharma Global Development, Inc.

800-888-7704

Astellas.registration@astellas.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

15 listed

Associated Retina Consultants — Phoenix, Arizona (recruiting)
Stanford University School of Medicine — Palo Alto, California (recruiting)
University of California Health - UC Davis — Sacramento, California (recruiting)
University of Florida Health - UF Health Jacksonville — Jacksonville, Florida (recruiting)
University of Miami Health System - Bascom Palmer Eye Institute — Miami, Florida (recruiting)
University of Illinois Chicago - UI Health — Chicago, Illinois (recruiting)
University of Michigan Health - Kellogg Eye Center — Ann Arbor, Michigan (recruiting)
Deep Blue Retina — Southaven, Mississippi (recruiting)
Duke Eye Center — Durham, North Carolina (recruiting)
Cincinnati Eye Institute — Cincinnati, Ohio (recruiting)
Casey Eye Institute - Oregon Health & Science University — Portland, Oregon (recruiting)
Wills Eye Physicians - Mid Atlantic Retina — Philadelphia, Pennsylvania (recruiting)

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FAQ about this NCT record

Is NCT07425574 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07425574?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07425574?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary