Phase 1/2 Open-Label Dose-Escalation Study to Evaluate Safety of a Single Intravitreal Injection of RTx-021 in Patients With Stargardt Disease

Recruiting Phase 1 Phase 2 Interventional Study
Stargardt Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
16 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
18 (estimated)
Sponsor
Ray Therapeutics, Inc. · Industry
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About This Trial

A Phase 1/2, open-label, non-randomized, dose-escalation study, where a minimum of 9 and a maximum of 18 eligible patients with Stargardt Disease will be enrolled sequentially in up to 3 dose cohorts of RTx-021. Enrolled patients will receive a single, unilateral intravitreal injection of RTx-021 in the study eye and be followed for 5 years.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Male and female patients \>= 16 years of age * Able to comply with the study visit schedule and all protocol assessments * Diagnosis of Stargardt Disease (genetic testing required) * Study eye and fellow eye Best Corrected Visual Acuity meeting study criteria * Presence of ret…
Contacts

Executive Clinical Director

858-617-8610

clinicaltrials@raytherapeutics.com

CONTACT