Safety and Efficacy Evaluation of LX111 Gene Therapy in DME Patients

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

The goal of this study is to evaluate the safety and efficacy of LX111 treatment of DME. This study will enroll participants aged ≥ 18 vears old to receive a single unilateral intravitreal (lVT) injection of LX111 to evaluate its safety and efficacy.

Eligibility criteria

Qualifiers

Willing to sign the informed consent, and willing to attend follow-up visits;

Age ≥ 18;

Type I or Type II diabetes mellitus with macular thickening secondary to DME involving the center of the fovea;

CST ≥ 300 μm in the study eye at Screening;

Disqualifiers

Active proliferative diabetic retinopathy (PDR);

Presence of iris neovascularization in the study eye at Screening;

Retinal laser photocoagulation in the study eye within 3 months prior to Screening;

Prior gene therapy in the study eye;

Trial design

Treatments tested in this trial

  • LX111 Injection

Treatment groups

32 Participants
are divided into 3 treatment groups

Sponsors and collaborators