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NCT07053358RecruitingEarly phase 1

Safety and Efficacy Evaluation of LX111 Gene Therapy in nAMD Patients

An Exploratory Clinical Study Evaluating LX111 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD)

Source: ClinicalTrials.gov · Last updated 10 Mar 2026

Brief summary (registry, in English)

The goal of this study is to evaluate the safety and efficacy of LX111 treatment of nAMD. This study will enroll subjects aged ≥ 50 vears old to receive a single unilateral intravitreal (lVT) injection of LX111 to evaluate its safety and efficacy.

Status (registry)
Recruiting
Phase (registry)
Early phase 1
Study type
Interventional
Enrollment
10 (estimated)
First submitted
27 Jun 2025
Start date
Jul 2025
Primary completion date
Nov 2026
Lead sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
NCT number
NCT07053358

What you commit to

  • Study type: Interventional · Early phase 1
  • Planned participants: 10
  • From Jul 2025 to the primary completion date, Nov 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • CNV or macular edema in the study eye secondary to diseases other than nAMD
  • Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement
  • Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months
  • Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg

Lab values

  • Uncontrolled diabetes defined as HbA1c \>8.0% within 28 days prior to screening

Who the study is looking for

  • Willing to sign the informed consent, and willing to attend follow-up visits.
  • Age ≥ 50
  • Diagnosis of active CNV secondary to neovascular AMD
  • BCVA ETDRS letters between 5 and 63
  • Subjects must have received a minimum of 2 injections within 6 months prior to screening and demonstrated a meaningful response to anti-VEGF therapy
  • 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.

Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.