Active — Not RecruitingPhase 2

Safety and Efficacy of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (VENUS)

China50 participantsStarted 2024-01-24

Plain-language summary

The goal of this study is to evaluate the overall safety and efficacy of LX102 gene therapy for nAMD.

Age range50 Years – 89 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Willing to sign the informed consent, and willing to attend follow-up visits.
✓. Age ≥ 50, and ≤ 89.
✓. Diagnosis of active CNV secondary to neovascular AMD.
✓. BCVA ETDRS letters between 19 and 73.
✓. Demonstrated a meaningful response to anti-VEGF therapy.

✕. 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.
✕. Absence of RPE tear at Screening.
✕. 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.
✕. Uncontrolled diabetes defined as HbA1c \>8.0%.

Mean change from baseline in Best Corrected Visual Acuity (BCVA)

Timeframe: 36 weeks

NCT IDNCT06196840

SponsorInnostellar Biotherapeutics Co.,Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-24