INNOSTELLAR-LX102A01-1

About this trial

Last updated a year ago

Recruiting

Interventional

Phase 1

50+ Years

All

Healthy Volunteers

Started 2 years ago

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

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

6. Demonstrated a meaningful response to anti-VEGF therapy

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 >7.5%