Safety and Efficacy Evaluation of LX111 Gene Therapy in DME Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LX111 Injection.
- Who it may be relevant to
- Registry conditions: Diabetic Macular Edema (DME). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Exploratory Clinical Study Evaluating LX111 Gene Therapy in Patients With Diabetic Macular Edema (DME)
Overview
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.
Detailed description
This trial is a prospective, multicenter, dose-ranging trial to evaluate the safety and efficacy of LX111 in participants with DME. The trial will be conducted in two parts: Dose Confirmation and Dose Expansion.
Interventions
- Genetic LX111 Injection
LX111 is an rAAV gene therapy vector carrying a coding sequence for VEGF-trap.
Primary outcome measures
- Adverse events and serious adverse events in the eyes and throughout the body within 364 days after LX111 treatment [Time frame: 52 weeks]
- Dose Limiting Toxicity [Time frame: 4 weeks]
Secondary outcome measures (4)
- Mean changes in BCVA from Baseline [Time frame: 12 weeks, 36 weeks, 52 weeks]
- Mean changes in Central Subfield Thickness (CST) from Baseline [Time frame: 12 weeks, 36 weeks, 52 weeks]
- The percentage of participants who received anti-VEGF supplemental injection within 52 weeks after LX111 treatment [Time frame: 52 weeks]
- Proportion of participants achieving an improvement or worsening in DR in the study eye per the ETDRS-DRSS on ultra-wide field fundus photography. [Time frame: 52 weeks]
Eligibility criteria
Inclusion criteria
- 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;
- BCVA ETDRS letters between 19 and 73;
- Participants must have received anti-VEGF therapy within 12 months prior to screening and demonstrated a meaningful response;
- Male subjects whose partner is a fertile female or female subjects who are fertile, agree to take effective contraceptive measures from the screening period until the last follow-up.
Exclusion criteria
- 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;
- The study eye has been treated with an intravitreal dexamethasone implant (Ozurdex®) within 6 months prior to Screening.
- Systemic anti-VEGF treatment within 3 months before Screening;
- Received an investigational drug, agent, device, or therapy (ocular or non-ocular) in the 3 months (or at least 5 half-lives, whichever is longer) prior to Screening;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Shanghai General Hospital — Shanghai
- Zhongshan Hospital — Shanghai
Identifiers
NCT: NCT07362927 · LX111-01