LX102 in Patients With Neovascular Age-Related Macular Degeneration (nAMD)

Last updated: January 8, 2024
Sponsor: Innostellar Biotherapeutics Co.,Ltd
Overall Status: Active - Recruiting

Phase

1

Condition

Geographic Atrophy

Macular Degeneration

Treatment

LX102 subretinal injection

Clinical Study ID

NCT06198413
INNOSTELLAR-LX102A01-1
  • Ages > 50
  • All Genders

Study Summary

The goal of this study is to evaluate the 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
  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 toscreening
  6. 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. 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 >7.5%

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: LX102 subretinal injection
Phase: 1
Study Start date:
February 27, 2023
Estimated Completion Date:
January 31, 2029

Study Description

This study will enroll subjects aged ≥ 50 years old to receive a single unilateral subretinal injection of LX102 to evaluate its safety and efficacy.

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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