Actively Recruiting

Phase 1
Phase 2
Age: 12Years +
All Genders
NCT06467344

Study to Evaluate ACDN-01 in ABCA4-related Stargardt Retinopathy (STELLAR)

Led by Ascidian Therapeutics, Inc · Updated on 2025-12-02

15

Participants Needed

10

Research Sites

337 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is an open-label, single ascending dose clinical trial in participants who have ABCA4-related retinopathies. This is the first-in-human clinical trial in which ACDN-01 will be evaluated for safety, tolerability, and preliminary efficacy following a single subretinal injection of ACDN-01.

CONDITIONS

Official Title

Study to Evaluate ACDN-01 in ABCA4-related Stargardt Retinopathy (STELLAR)

Who Can Participate

Age: 12Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Presence of mutations in the ABCA4 gene
  • ABCA4 retinopathy phenotype (Stargardt disease type 1 or cone-rod dystrophy)
  • Area of atrophy located in the macula of the study eye
  • Best corrected visual acuity of 20/50 (0.4 logMAR) or worse
Not Eligible

You will not qualify if you...

  • Presence of pathogenic or likely pathogenic mutations in other genes causing cone-rod dystrophy or Stargardt maculopathy
  • Retinal disease other than ABCA4-related retinopathy
  • Any medical, psychiatric, or physical condition, including substance abuse, that may prevent safe participation or adherence to study visits or affect study results

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 10 locations

1

University of San Francisco

San Francisco, California, United States, 94158

Actively Recruiting

2

Vitreo Retinal Associates

Gainesville, Florida, United States, 32607

Actively Recruiting

3

Bascom Palmer Eye Institute

Miami, Florida, United States, 33136

Actively Recruiting

4

Wilmer Eye Institute at John Hopkins

Baltimore, Maryland, United States, 21218

Actively Recruiting

5

Massachusetts Eye and Ear

Boston, Massachusetts, United States, 02114

Actively Recruiting

6

University of Michigan Kellogg Eye Center

Ann Arbor, Michigan, United States, 48105

Actively Recruiting

7

Cincinnati Eye Institute

Cincinnati, Ohio, United States, 45245

Actively Recruiting

8

Casey Eye Institute OHSU

Portland, Oregon, United States, 97239

Actively Recruiting

9

Retina Foundation of the Southwest

Dallas, Texas, United States, 75382

Actively Recruiting

10

Retina Consultants of Texas

Houston, Texas, United States, 77401

Actively Recruiting

Loading map...

Research Team

A

Associate Director, Clinical Operations

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Study to Evaluate ACDN-01 in ABCA4-related Stargardt Retinopathy (STELLAR) | DecenTrialz