LX102 gene therapy for neovascular (wet) age-related macular degeneration

A Phase III, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Subretinal Injection of LX102 in Participants With Neovascular Age-Related Macular Degeneration - The STELLAR Trial

This trial will test whether a single subretinal injection of LX102 gene therapy can maintain or improve vision in people aged 50–80 with active neovascular (wet) AMD who previously responded to aflibercept.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 332 (estimated)
• Ages: 50 Years to 80 Years
• Sex: All
• Sponsor: Innostellar Biotherapeutics Co.,Ltd (Industry-sponsored)
• Locations: 31 sites (Hefei, Anhui and 30 other locations)
• Trial ID: NCT07317934 on ClinicalTrials.gov

What this trial studies

This is a Phase III, randomized, open-label, active-controlled study comparing one subretinal injection of LX102 to standard aflibercept treatment in eyes with active choroidal neovascularization from nAMD. Participants are randomized to receive a single gene-therapy injection versus ongoing aflibercept, with vision measured over time. The primary endpoint is mean change in best-corrected visual acuity (BCVA) from baseline averaged at weeks 40 and 48. Key eligibility includes ages 50–80, prior clinical response to aflibercept, BCVA between 24 and 78 letters, and a pseudophakic study eye.

Who should consider this trial

Good fit: Ideal candidates are adults 50–80 with active nAMD in the study eye, baseline BCVA 24–78 letters, documented prior response to aflibercept, and who are pseudophakic in the study eye.

Not a fit: Patients with non-AMD causes of CNV, subfoveal fibrosis or atrophy, prior retinal detachment, active or autoimmune uveitis, advanced glaucoma, or other conditions limiting visual improvement are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, LX102 could reduce or eliminate the need for frequent anti-VEGF injections and maintain or improve vision with a single treatment.

How similar studies have performed: Earlier-phase trials of intraocular gene therapies delivering anti-VEGF proteins (for example RGX-314 and ADVM-022) have shown promising durability but mixed results, and larger trials are ongoing.

Eligibility criteria

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.

Where this trial is running

Hefei, Anhui and 30 other locations

• The First Affiliated Hospital of University of Science and Technology of China — Hefei, Anhui, China (Not_yet_recruiting)
• Beijing Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• The First Affiliated Hospital of Jinan University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Joint Shantou International Eye Center, Shantou University and the Chinese University of Hong Kong — Shantou, Guangdong, China (Not_yet_recruiting)
• Zhongshan Ophthalmic Center, Sun Yat-sen University — Zhongshan, Guangdong, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (Not_yet_recruiting)
• Central Theater Command General Hospital of PLA — Wuhan, Hubei, China (Not_yet_recruiting)
• The Second Xiangya Hospital, Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• Aier Eye Hospital Group Co., LTD. Changsha Aier Eye Hospital — Changsha, Hunan, China (Not_yet_recruiting)
• The Affiliated Eye Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Not_yet_recruiting)
• Xuzhou First People's Hospital — Xuzhou, Jiangsu, China (Not_yet_recruiting)
• The Second Hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (Not_yet_recruiting)
• Shandong Eye Hospital — Jinan, Shandong, China (Not_yet_recruiting)
• Qingdao Eye Hospital Affiliated to Shandong First Medical University — Qingdao, Shandong, China (Not_yet_recruiting)
• Eye & ENT Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Shanghai General Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Shanxi Eye Hospital — Taiyuan, Shanxi, China (Not_yet_recruiting)
• Shanxi Bethune Hospital — Taiyuan, Shanxi, China (Not_yet_recruiting)
• Xi 'an People's Hospital (Xi 'an No.4 Hospital) — Xi’an, Shanxi, China (Not_yet_recruiting)
• The First Affiliated Hospital of Air Force Medical University — Xi’an, Shanxi, China (Not_yet_recruiting)
• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Not_yet_recruiting)
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Not_yet_recruiting)
• Tianjin Eye Hospital — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)
• Tianjin Medical University Eye Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• The Eye Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Not_yet_recruiting)

Conditions Neovascular Age-Related Macular Degeneration; Wet AMD