Authorised Phase I and Phase II (Integrated)- First administration to humans Stargardt Disease (STGD1)

An Open-label, Multicenter Trial to Assess Safety and Efficacy of a Subretinal Administration of AAVB-039

EU CTIS ID: 2025-522207-15-01

What this study is testing

To determine the safety, tolerability and efficacy of a single administration of AAVB-039 via subretinal injection

  • Phase I and Phase II (Integrated)- First administration to humans

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Molecular diagnosis of Stargardt disease due to ABCA4 mutation
  • Aged ≥8 years to ≤55 years inclusive
  • Willingness to adhere to protocol per informed consent
  • No history of vitreoretinal or retinal macular surgery, No current history of cancer for 5 years, No history of myocardial infarct, stroke, or other heart conditions < 6 months

You likely can't join if

  • Unwillingness to meet the requirements of the study
  • Participation in a clinical study with another Investigation Medicinal Product
  • Previous participation in another gene or cell therapy trial
  • Any condition that would preclude subretinal surgery
  • Complicating ocular and/or systemic diseases

The study team makes the final eligibility decision.

Where it's taking place

  • United Kingdom
  • United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.