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Safety and Efficacy Evaluation of LX111 Gene Therapy in nAMD Patients

Safety and Efficacy Evaluation of LX111 Gene Therapy in nAMD Patients

Recruiting
50 years and older
All
Phase N/A

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Overview

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.

Eligibility

Inclusion Criteria:

  1. Willing to sign the informed consent, and willing to attend follow-up visits.
  2. Age ≥ 50
  3. Diagnosis of active CNV secondary to neovascular AMD
  4. BCVA ETDRS letters between 5 and 63
  5. Subjects must have received a minimum of 2 injections within 6 months prior to screening and demonstrated a meaningful response to anti-VEGF therapy
  6. 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. CNV or macular edema in the study eye secondary to diseases other than nAMD
  2. Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement
  3. Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months
  4. Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg
  5. Uncontrolled diabetes defined as HbA1c >8.0% within 28 days prior to screening

Study details
    Neovascular Age-related Macular Degeneration

NCT07053358

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

18 July 2025

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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