Early Phase 1 Macular Degeneration Trial, Recruiting NCT07063251 Sponsor: HuidaGene Therapeutics Co., Ltd. Condition: Macular Degeneration
Back to Macular Degeneration

Early Phase 1 Macular Degeneration Trial, Recruiting

NCT07063251
Recruiting Early Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 6 and 17 years old (inclusive) and have been diagnosed with Stargardt disease
  • You have a specific gene change (at least one ABCA4 gene variant on each chromosome) linked to Stargardt disease
  • Both of your eyes have clearly visible areas of damage in the central part of the retina (the macula) that are consistent with Stargardt disease
  • Your vision meets certain requirements measured using a specific eye chart called the ETDRS letter chart
  • You are willing to use contraception throughout the study
  • Your blood tests, urine tests, and eye examinations meet the standards required by the trial

Who may not be able to join:

  • You currently have, or have a history of, inflammation or swelling inside either eye (called uveitis)
  • You have had an infection in or around either eye within the past 2 weeks
  • You have, or have had, a condition affecting the clear front surface of the eye (corneal dystrophy) in the eye being studied
  • You have a history of HIV or hepatitis A, B, or C infection
  • You have previously received any gene therapy or cell therapy treatment (such as a stem cell transplant)
  • You have had eye surgery in the study eye within the past 3 months
  • You have taken part in another clinical trial testing an oral (taken by mouth) treatment for Stargardt disease within the past 3 months, or within 5 half-lives of the last dose you received
  • You are currently taking any other treatment that the trial doctor believes could interfere with the eye procedure or the healing process
  • You have any other condition that the trial doctor believes would prevent you from completing all follow-up visits or make participation unsuitable for you (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: Study Director, HuidaGene Therapeutics Co., Ltd.

Phone: +86 021-25076143

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Early Phase 1
Sponsor
HuidaGene Therapeutics Co., Ltd.
Registry
ClinicalTrials.gov
Start date
20 August 2025
Est. completion
28 February 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Incidence and severity of systemic adverse events

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov