Open-Label Extension: Tolerability and Effects of ALK-001 on Stargardt Disease (TEASE) (NCT04239625)
A Phase 2 Multicenter, Double-Masked, Randomized, Placebo-Controlled Study to Investigate the Long Term Safety, Tolerability, Pharmacokinetics and Effects of ALK-001 on the Progression of Stargardt Disease
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this open-label, multicenter study is to determine the long-term safety, pharmacokinetics and effects of ALK-001 (C20-D3-retinyl acetate) on the progression of Stargardt disease. This study is an extension of NCT02402660 and enrolls participants who are at least 8 years old. Enrollment is by invitation only. Funding Source - FDA OOPD
Who can join: Review the eligibility criteria below.
Location: Alkeus Site — Phoenix, Arizona
Age range: 8 Years to 70 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (8 Sites)
- Alkeus Site — Phoenix, Arizona
- Alkeus Site — Los Angeles, California
- Alkeus Site — Aurora, Colorado
- Alkeus Site — Gainesville, Florida
- Alkeus Site — Indianapolis, Indiana
- Alkeus Site — Grand Rapids, Michigan
- Alkeus Site — Westbury, New York
- Alkeus Site — Silverdale, Washington
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Stargardt Disease
- An Observational Study in Children and Adults With Stargardt Disease — Dallas, Texas
- Non-interventional Long Term Follow-up Study of Participants Previously Enrolled in the STARLIGHT Study — Miami, Florida
- A Phase 2/3 Trial to Assess the Efficacy and Safety of OCU410ST for Stargardt Disease — Phoenix, Arizona
- Phase 1/2 Open-Label Dose-Escalation Study to Evaluate Safety of a Single Intravitreal Injection of RTx-021 in Patients With Stargardt Disease — Bakersfield, California
- Study to Evaluate ACDN-01 in ABCA4-related Stargardt Retinopathy (STELLAR) — San Francisco, California
Explore by condition: All Stargardt Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.