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

Last updated: December 25, 2023
Sponsor: Innostellar Biotherapeutics Co.,Ltd
Overall Status: Active - Recruiting

Phase

2

Condition

Macular Degeneration

Geographic Atrophy

Treatment

Aflibercept intravitreal injection

LX102 subretinal injection

Clinical Study ID

NCT06196840
INNOSTELLAR-LX102A01-2
  • Ages 50-89
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 conditionpreventing visual acuity improvement.
  3. Absence of RPE tear at Screening.
  4. Acute coronary syndrome, myocardial infarction or coronary artery revascularization,CVA, TIA in the last 6 months.
  5. Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100mmHg.
  6. Uncontrolled diabetes defined as HbA1c >8.0%.

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Aflibercept intravitreal injection
Phase: 2
Study Start date:
December 21, 2023
Estimated Completion Date:
May 31, 2029

Study Description

In this Phase 2, multi-center, randomized controlled study, subjects will be randomized to receive one of the two dose levels of LX102 (n=20 for each dose level), or aflibercept (n=10).

Safety, tolerability, and efficacy will be evaluated for a period of approximately 1 year from baseline.

Connect with a study center

  • Anhui Provincial Hospital

    Hefei, Anhui
    China

    Active - Recruiting

  • Zhejiang University Eye Hospital

    Hangzhou, Zhejiang
    China

    Active - Recruiting

  • Shanghai General Hospital

    Shanghai,
    China

    Active - Recruiting

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