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Tests treatment safety and results for Diabetic Macular Edema (DME)
Official title Safety and Efficacy Evaluation of LX111 Gene Therapy in DME Patients
ClinicalTrials.gov ID: NCT07362927
What this study is testing
What is LX111 Injection?
LX111 Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for diabetic macular edema (dme).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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;
You likely can't join if
- 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;
See the full eligibility 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 people whose partner is a fertile female or female people who are fertile, agree to take effective contraceptive measures from the screening period until the last follow-up.
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. 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 ClinicalTrials.gov; the study team decides eligibility.