Evaluating LX102 gene therapy for neovascular age-related macular degeneration
A Phase 2, Randomized Controlled, Open-Label Study to Establish the Safety and Efficacy of LX102 in Patients With Neovascular Age-related Macular Degeneration (nAMD) (VENUS)
This study is testing if a new gene therapy called LX102 can help improve vision in people with neovascular age-related macular degeneration.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 50 Years to 89 Years |
| Sex | All |
| Sponsor | Innostellar Biotherapeutics Co.,Ltd Industry-sponsored |
| Locations | 3 sites (Hefei, Anhui and 2 other locations) |
| Trial ID | NCT06196840 on ClinicalTrials.gov |
What this trial studies
This Phase 2, multi-center, randomized controlled study aims to assess the safety and efficacy of LX102 gene therapy in patients with neovascular age-related macular degeneration (nAMD). Participants will be randomly assigned to receive either one of two dose levels of LX102 or aflibercept, with a total of 60 subjects involved. The study will monitor safety, tolerability, and efficacy over approximately one year from the baseline assessment. The goal is to determine if LX102 can provide a meaningful improvement in vision for patients suffering from this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 50 to 89 with active choroidal neovascularization secondary to neovascular AMD who have previously responded to anti-VEGF therapy.
Not a fit: Patients with neovascular AMD caused by conditions other than nAMD or those with uncontrolled systemic health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could offer a new treatment option that improves vision for patients with neovascular age-related macular degeneration.
How similar studies have performed: Other studies have shown promise with gene therapy approaches for retinal diseases, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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%.
Where this trial is running
Hefei, Anhui and 2 other locations
- Anhui Provincial Hospital — Hefei, Anhui, China (Recruiting)
- Zhejiang University Eye Hospital — Hangzhou, Zhejiang, China (Recruiting)
- Shanghai General Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Yang Liu
- Email: liuyang@innostellarbio.com
- Phone: +86-021-50770353
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.