LX111 gene therapy for adults with diabetic macular edema.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, dose‑ranging early‑phase trial that delivers a single unilateral intravitreal injection of LX111 to adults with center‑involving DME. The study is conducted in two parts: dose confirmation followed by dose expansion to identify a safe dose and then enroll more participants at that dose. Eligible participants must be ≥18, have central subfield thickness ≥300 μm, BCVA 19–73 ETDRS letters, and a prior meaningful response to anti‑VEGF within 12 months. Primary outcomes emphasize safety and tolerability with secondary measures of retinal thickness and visual acuity during follow‑up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Willing to sign the informed consent, and willing to attend follow-up visits;
2. Age ≥ 18;
3. Type I or Type II diabetes mellitus with macular thickening secondary to DME involving the center of the fovea;
4. CST ≥ 300 μm in the study eye at Screening;
5. BCVA ETDRS letters between 19 and 73;
6. Participants must have received anti-VEGF therapy within 12 months prior to screening and demonstrated a meaningful response;
7. 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:

1. Active proliferative diabetic retinopathy (PDR);
2. Presence of iris neovascularization in the study eye at Screening;
3. Retinal laser photocoagulation in the study eye within 3 months prior to Screening;
4. Prior gene therapy in the study eye;
5. The study eye has been treated with an intravitreal dexamethasone implant (Ozurdex®) within 6 months prior to Screening.
6. Systemic anti-VEGF treatment within 3 months before Screening;
7. 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;

Where it's running

• Shanghai General Hospital
  Shanghai, China Recruiting
• Zhongshan Hospital
  Shanghai, China Not yet recruiting

Study contacts

• Study coordinator: Li Su
• Email: li.su@shgh.cn
• Phone: +86 02136126254

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Oral N-Acetylcysteine for Diabetic Macular Edema

  This study tests whether taking N-acetylcysteine by mouth can help people with center-involving diabetic macular edema who don’t yet need anti-VEGF therapy.

  Recruiting Phase 2 Tanta University · Damietta · NCT07917338

• 4D-150 gene therapy injected into the eye for adults with diabetic macular edema

  This study tests whether a one-time intravitreal injection of 4D-150 can help adults with diabetic macular edema compare to aflibercept.

  Recruiting at 23 sites Phase 3 4D Molecular Therapeutics · Scottsdale, Arizona and 93 other locations · NCT07867080

• Corticosteroid for Diabetic Macular Edema (DME) in Adults with Diabetic Retinopathy

  This trial tests whether intravitreal corticosteroid injections can influence inflammatory biomarkers and improve DME in adults with type 2 diabetes.

  Recruiting Phase 4 Vanderbilt University Medical Center · Nashville, Tennessee · NCT07843849

• Oral BGE-102 for center-involved diabetic macular edema (Phase 2)

  This trial tests whether taking BGE-102 by mouth, alone or with an anti-VEGF drug, can help preserve or improve vision in adults with center-involved diabetic macular edema.

  Recruiting at 16 sites Phase 2 BioAge Labs, Inc. · Bakersfield, California and 15 other locations · NCT07812090

• Tabirafusp Tedromer vs Aflibercept for Diabetic Macular Edema (DME)

  This study tests whether Tabirafusp Tedromer can work as well as or better than Aflibercept to help people with Diabetic Macular Edema.

  Recruiting at 52 sites Phase 3 Kodiak Sciences Inc · Scottsdale, Arizona and 51 other locations · NCT07734844

• Early imaging changes with faricimab versus biosimilar ranibizumab for diabetic retinal disease

  This trial will see if faricimab or a biosimilar ranibizumab causes different early OCT and OCTA imaging changes in adults with diabetic retinopathy or diabetic macular edema who need anti-VEGF injections.

  Recruiting Osijek University Hospital · Osijek · NCT07520045

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.