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

NCT07317934

RecruitingPhase 3

Sponsor: Innostellar Biotherapeutics Co.,Ltd

Conditions: Neovascular Age-Related Macular Degeneration (nAMD), Wet AMD

Interventions: LX102, Aflibercept

Countries: China

This is 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 study will evaluate a single subretinal injection of LX102 compared to an active comparator. The primary endpoint of this study is the mean change from D0 in BCVA based on an average at weeks 48 and 56.

Eligibility overview

Sex: ALL

Age: 50 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

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 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.

Locations (36)

Hefei, Anhui, China
Beijing, Beijing Municipality, China
Beijing, Beijing Municipality, China
Beijing, Beijing Municipality, China
Chongqing, Chongqing Municipality, China
Chongqing, Chongqing Municipality, China
Guangzhou, Guangdong, China
Shantou, Guangdong, China
Zhongshan, Guangdong, China
Xingtai, Hebei, China
Harbin, Heilongjiang, China
Wuhan, Hubei, China
Wuhan, Hubei, China
Changsha, Hunan, China
Changsha, Hunan, China
Nanjing, Jiangsu, China
Xuzhou, Jiangsu, China
Changchun, Jilin, China
Shenyang, Liaoning, China
Jinan, Shandong, China
Jinan, Shandong, China
Qingdao, Shandong, China
Shanghai, Shanghai Municipality, China
Shanghai, Shanghai Municipality, China
Shanghai, Shanghai Municipality, China
Shanghai, Shanghai Municipality, China
Taiyuan, Shanxi, China
Taiyuan, Shanxi, China
Xi’an, Shanxi, China
Xi’an, Shanxi, China
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