Actively Recruiting
Efficacy and Safety of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (STELLAR)
Led by Innostellar Biotherapeutics Co.,Ltd · Updated on 2026-03-05
332
Participants Needed
31
Research Sites
333 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 40 and 48.
CONDITIONS
Official Title
Efficacy and Safety of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (STELLAR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written, signed informed consent for this study
- Age 50 to 80 years old
- Active choroidal neovascularization secondary to neovascular age-related macular degeneration in the study eye confirmed by FFA or OCT
- Best corrected visual acuity between 24 and 78 letters in the study eye at screening
- Demonstrated clinical response to aflibercept treatments in the study eye confirmed by the Reading Center
- No anti-VEGF therapy in the study eye within 28 days before screening
- Must be pseudophakic in the study eye (at least 4 weeks after cataract surgery)
You will not qualify if you...
- Any condition that could limit vision improvement in the study eye as judged by the investigator
- Choroidal neovascularization or macular edema in the study eye caused by conditions other than age-related macular degeneration
- Subfoveal fibrosis or atrophy in the study eye as determined by the Reading Center
- History of retinal detachment in the study eye
- History of idiopathic or autoimmune uveitis in either eye
- Advanced glaucoma in the study eye
- History of vitrectomy surgery in the study eye
- Intraocular surgery in the study eye within 1 month before screening
- History of ocular or systemic gene therapy
- Recent myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China, 230601
Not Yet Recruiting
2
Beijing Hospital
Beijing, Beijing Municipality, China, 100730
Not Yet Recruiting
3
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Not Yet Recruiting
4
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400010
Not Yet Recruiting
5
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China, 510632
Not Yet Recruiting
6
Joint Shantou International Eye Center, Shantou University and the Chinese University of Hong Kong
Shantou, Guangdong, China, 515041
Not Yet Recruiting
7
Zhongshan Ophthalmic Center, Sun Yat-sen University
Zhongshan, Guangdong, China, 510623
Not Yet Recruiting
8
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150001
Not Yet Recruiting
9
Central Theater Command General Hospital of PLA
Wuhan, Hubei, China, 430060
Not Yet Recruiting
10
The Second Xiangya Hospital, Central South University
Changsha, Hunan, China, 410011
Not Yet Recruiting
11
Aier Eye Hospital Group Co., LTD. Changsha Aier Eye Hospital
Changsha, Hunan, China, 410015
Not Yet Recruiting
12
The Affiliated Eye Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Not Yet Recruiting
13
Xuzhou First People's Hospital
Xuzhou, Jiangsu, China, 221002
Not Yet Recruiting
14
The Second Hospital of Jilin University
Changchun, Jilin, China, 130022
Not Yet Recruiting
15
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Not Yet Recruiting
16
Shandong Eye Hospital
Jinan, Shandong, China, 250021
Not Yet Recruiting
17
Qingdao Eye Hospital Affiliated to Shandong First Medical University
Qingdao, Shandong, China, 266071
Not Yet Recruiting
18
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200031
Not Yet Recruiting
19
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080
Actively Recruiting
20
Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200092
Not Yet Recruiting
21
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 201801
Not Yet Recruiting
22
Shanxi Eye Hospital
Taiyuan, Shanxi, China, 030002
Not Yet Recruiting
23
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030032
Not Yet Recruiting
24
Xi 'an People's Hospital (Xi 'an No.4 Hospital)
Xi’an, Shanxi, China, 710004
Not Yet Recruiting
25
The First Affiliated Hospital of Air Force Medical University
Xi’an, Shanxi, China, 710032
Not Yet Recruiting
26
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
27
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 646100
Not Yet Recruiting
28
Tianjin Eye Hospital
Tianjin, Tianjin Municipality, China, 300020
Not Yet Recruiting
29
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China, 300384
Actively Recruiting
30
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310014
Not Yet Recruiting
31
The Eye Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325027
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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