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

Plain-language summary

This study examines LX102 gene therapy, given as a subretinal injection, in patients with neovascular age-related macular degeneration (nAMD). Participants aged 50 and over with active choroidal neovascularisation took part. It is a Phase 1 study, active but not currently recruiting.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Active, not recruiting

Sponsor

Innostellar Biotherapeutics Co.,Ltd

Intervention

LX102 subretinal injection

Start date

2/27/2023

Estimated completion

1/1/2029

Countries

China

Related genes

Locations

• Hefei, China
• Hangzhou, China
• Shanghai, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine 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
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%