Gene therapy for neovascular age-related macular degeneration
A Dose-Escalation Study of LX102 Gene Therapy for Neovascular Age-Related Macular Degeneration (nAMD)
This study is testing a new gene therapy called LX102 to see if it can safely improve vision in older adults with a specific type of age-related eye disease who have already responded well to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Innostellar Biotherapeutics Co.,Ltd Industry-sponsored |
| Locations | 3 sites (Hefei, Anhui and 2 other locations) |
| Trial ID | NCT06198413 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of LX102, a gene therapy, in patients with neovascular age-related macular degeneration (nAMD). Participants aged 50 and older will receive a single unilateral subretinal injection of LX102. The study aims to determine how well this treatment works and its safety profile in individuals who have previously shown a meaningful response to anti-VEGF therapy. Follow-up visits will be conducted to monitor the outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 50 and older diagnosed with active choroidal neovascularization secondary to neovascular AMD who have previously responded to anti-VEGF therapy.
Not a fit: Patients with neovascular AMD who have not responded to previous anti-VEGF treatments or have other retinal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from nAMD, potentially improving their vision and quality of life.
How similar studies have performed: While gene therapy approaches for AMD are being explored, this specific intervention is novel and has not been widely tested in prior studies.
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 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%
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.