Efficacy and Safety of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (STELLAR)
NCT ID: NCT07317934
Last Updated: 2026-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
332 participants
INTERVENTIONAL
2026-01-31
2032-06-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LX102
LX102
Study eyes will receive a single subretinal injection of LX102.
Aflibercept
Aflibercept
Study eyes will receive 3 monthly loading doses of aflibercetp 2mg IVT and aflibercept 2mg IVT every 8 weeks.
Interventions
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LX102
Study eyes will receive a single subretinal injection of LX102.
Aflibercept
Study eyes will receive 3 monthly loading doses of aflibercetp 2mg IVT and aflibercept 2mg IVT every 8 weeks.
Eligibility Criteria
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Inclusion Criteria
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
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.
50 Years
80 Years
ALL
No
Sponsors
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Innostellar Biotherapeutics Co.,Ltd
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
Beijing Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
Joint Shantou International Eye Center, Shantou University and the Chinese University of Hong Kong
Shantou, Guangdong, China
Zhongshan Ophthalmic Center, Sun Yat-sen University
Zhongshan, Guangdong, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Central Theater Command General Hospital of PLA
Wuhan, Hubei, China
The Second Xiangya Hospital, Central South University
Changsha, Hunan, China
Aier Eye Hospital Group Co., LTD. Changsha Aier Eye Hospital
Changsha, Hunan, China
The Affiliated Eye Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Xuzhou First People's Hospital
Xuzhou, Jiangsu, China
The Second Hospital of Jilin University
Changchun, Jilin, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong Eye Hospital
Jinan, Shandong, China
Qingdao Eye Hospital Affiliated to Shandong First Medical University
Qingdao, Shandong, China
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanxi Eye Hospital
Taiyuan, Shanxi, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Xi 'an People's Hospital (Xi 'an No.4 Hospital)
Xi’an, Shanxi, China
The First Affiliated Hospital of Air Force Medical University
Xi’an, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Tianjin Eye Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
The Eye Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Other Identifiers
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INNOSTELLAR-LX102A03
Identifier Type: -
Identifier Source: org_study_id
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