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
Sponsors and collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lead sponsor
Innostellar Biotherapeutics Co.,Ltd
Collaborator