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

Plain-language summary

This study evaluates the efficacy and safety of LX102, a gene therapy, compared with Aflibercept in patients with neovascular age-related macular degeneration (nAMD). It is open to patients aged 50 to 80 with confirmed active nAMD in the study eye who have responded to Aflibercept. It is being carried out in Phase 3 and is currently recruiting 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 3

Status

Recruiting

Sponsor

Innostellar Biotherapeutics Co.,Ltd

Intervention

LX102, Aflibercept

Start date

1/14/2026

Estimated completion

6/4/2032

Countries

China

Related genes

Locations

• Hefei, China
• Beijing, China
• Beijing, China
• Chongqing, China
• Guangzhou, China
• Shantou, China
• Zhongshan, China
• Harbin, China
• Wuhan, China
• Changsha, China
• Changsha, China
• Nanjing, China
• Xuzhou, China
• Changchun, China
• Jinan, China
• Jinan, China
• Qingdao, China
• Shanghai, China
• Shanghai, China
• Shanghai, China
• Shanghai, China
• Taiyuan, China
• Taiyuan, China
• Xi’an, China
• Xi’an, China
• Chengdu, China
• Chengdu, China
• Tianjin, China
• Tianjin, China
• Hangzhou, China
• Wenzhou, 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 and able to provide written, signed informed consent for this study;
2. Age ≥50 and ≤80 years old;
3. active CNV secondary to nAMD in the study eye confirmed by FFA or OCT;
4. The BCVA between 24 and 78 letters (inclusive) in the study eye at Screening;
5. Demonstrated clinical response to aflibercept treatments in the study eye confirmed by the Reading Center;
6. No anti-VEGF therapy in study eye within 28 days before screening;
7. Must be pseudophakic in the study eye (at least 4 weeks after cataract surgery).

Exclusion Criteria:

1. Any condition in the investigator's opinion that could limit VA improvement in the study eye.
2. CNV or macular edema in the study eye secondary to any causes other than AMD
3. Subfoveal fibrosis or atrophy in the study eye, as determined by CRC;
4. History of retinal detachment in the study eye at any time;
5. History of idiopathic or autoimmune uveitis in either eye;
6. Advanced glaucoma in the study eye;
7. History of vitrectomy surgery in the study eye;
8. History of intraocular surgery within 1 month before screening in the study eye;
9. History of ocular or systemic gene therapy;
10. Recent myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months.