Actively Recruiting
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
Led by Innostellar Biotherapeutics Co.,Ltd · Updated on 2026-03-05
332
Participants Needed
31
Research Sites
222 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of LX102 gene therapy in people aged 50 to 80 with neovascular age-related macular degeneration (nAMD), a condition affecting the eyes. This Phase III trial compares a single subretinal injection of LX102 to an active treatment called aflibercept. The main goal is to measure changes in visual acuity over time, specifically looking at the average score at weeks 40 and 48 after treatment. Participants are randomly assigned to one of two groups: one group receives one injection of LX102 under the retina, while the other group receives aflibercept through three monthly eye injections followed by injections every eight weeks. The treatments are given during the study period, and no masking is used, meaning both the researchers and participants know which treatment is given. During the study, participants will have their vision tested and eye health monitored at various points, including weeks 40 and 48. Researchers will track changes in visual acuity, the thickness of the central retina, presence of fluid in the retina, and the need for additional anti-VEGF injections. Safety is closely monitored by recording any eye-related or other adverse events. The trial lasts for nearly two years, starting in early 2026 and ending in mid-2032, allowing for long-term observation of results and safety.
CONDITIONS
Brief 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 fluorescein angiography or optical coherence tomography
- 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 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 visual acuity improvement in the study eye as judged by the investigator
- Choroidal neovascularization or macular edema in the study eye due to causes other than age-related macular degeneration
- Subfoveal fibrosis or atrophy in the study eye as determined by the Central Reading Center
- History of retinal detachment in the study eye at any time
- History of idiopathic or autoimmune uveitis in either eye
- Advanced glaucoma in the study eye
- History of vitrectomy surgery in the study eye
- History of intraocular surgery within 1 month before screening in the study eye
- History of ocular or systemic gene therapy
- Recent myocardial infarction, stroke, or transient ischemic attack within the past 6 months
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 weeks
Participants receive either a single subretinal injection of LX102 or a series of aflibercept injections as active treatment for neovascular age-related macular degeneration.
1 baseline visit and multiple follow-up visits through 48 weeks
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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