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

Plain-language summary

This study investigates the safety and effectiveness of a gene therapy called LX102 in patients with neovascular age-related macular degeneration (nAMD). The treatment is given as a subretinal injection and compared with Aflibercept, and the study enrolled patients aged 50 to 89 who had responded to anti-VEGF therapy. The study is being conducted in Phase 2 and is currently active but not recruiting new participants.

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

Trial details

Phase

Phase 2

Status

Active, not recruiting

Sponsor

Innostellar Biotherapeutics Co.,Ltd

Intervention

LX102 subretinal injection, Aflibercept intravitreal injection

Start date

1/24/2024

Estimated completion

10/1/2029

Countries

China

Related genes

Locations

• Hefei, China
• Hangzhou, China
• Beijing, China
• Chengdu, China
• Guangzhou, China
• Guangzhou, China
• Shanghai, China
• Shanghai, China
• Taiyuan, China
• Tianjin, China
• Xuzhou, 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, 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 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. 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 ≥100 mmHg.
6. Uncontrolled diabetes defined as HbA1c \>8.0%.