Fellow-eye Study (FE) of LX101 in Subjects With Inherited Retinal Dystrophy

Launched by INNOSTELLAR BIOTHERAPEUTICS CO.,LTD · Jan 8, 2024

Keywords

ClinConnect Summary

The Fellow-eye Study (FE) is a clinical trial aimed at testing a treatment called LX101 for people with a condition known as inherited retinal dystrophy, which affects vision. In this study, up to nine participants who have already received LX101 in one eye will be given the treatment in their other eye to see how safe it is to do so. This is important because it helps researchers understand if treating both eyes is a good approach for improving vision.

To be eligible for this study, participants must be at least 6 years old and have already received LX101 in one eye. They cannot have had any other gene therapy except for LX101 and should not have any active eye infections or recent eye surgeries. If chosen to participate, individuals will undergo careful monitoring after receiving the treatment in their other eye. This trial is currently recruiting participants of all genders, making it an inclusive opportunity for those who qualify.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Prior subretinal administration of LX101 (unilateral)
• • ≥ 6 years old Signed written informed consent
• Exclusion Criteria:
• • Prior gene therapy except LX101 Active intraocular or periocular infections Lacking of sufficient surviving retinal cells Prior ocular surgery within six months Retinoid like compounds or precursors were taken within three months Complicating systemic diseases Clinically significant abnormal baseline laboratory values Using of any retinal toxic compounds