Neovascular Age-Related Macular Degeneration (nAMD)Phase 3NCT07317934
Efficacy and Safety of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (STELLAR)
A Phase 3 study testing LX102 and Aflibercept in people with Neovascular Age-Related Macular Degeneration (nAMD) and Wet AMD, run by Innostellar Biotherapeutics Co.,Ltd at 36 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Neovascular Age-Related Macular Degeneration (nAMD), Wet AMD
- What is being tested?
- LX102 and Aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 36 sitesChina
- Study dates
- 14 Jan 2026to 4 Jun 2032
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written, signed informed consent for this study;
- Age ≥50 and ≤80 years old;
- Active CNV secondary to nAMD in the study eye confirmed by FFA or OCT;
- The BCVA between 24 and 78 letters (inclusive) 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.
Who cannot join
- Any condition in the investigator's opinion that could limit VA improvement in the study eye.
- CNV or macular edema in the study eye secondary to any causes other than AMD
- Subfoveal atrophy in the study eye, as determined by CRC;
- 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;
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- 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, cerebrovascular accident, or transient ischemic attack within the past 6 months.
Trial locations and contacts
36 sites in 1 country. Contact the study team or a site near you to ask about taking part.
36 sites in 1 country
China36 sites, 36 recruiting
- Recruiting
Beijing Aier-Intech Eye Hospital
Beijing, Beijing Municipality, 100000
Principal Investigator, +86 010-67715558-432, med@innostellarbio.com
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100730
Principal Investigator, +86 010-85136109, med@innostellarbio.com
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Principal Investigator, +86 010-69155180, med@innostellarbio.com
- Recruiting
The Second Hospital of Jilin University
Changchun, Jilin, 130022
Principal Investigator, +86 0431-88796522, med@innostellarbio.com
- Recruiting
The Second Xiangya Hospital, Central South University
Changsha, Hunan, 410011
Principal Investigator, +86 0731-85292097, med@innostellarbio.com
- Recruiting
Aier Eye Hospital Group Co., LTD. Changsha Aier Eye Hospital
Changsha, Hunan, 410015
Principal Investigator, +86 0731-85223462, med@innostellarbio.com
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Principal Investigator, +86 028-85422654, med@innostellarbio.com
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 646100
Principal Investigator, +86 028-87393401, med@innostellarbio.com
- Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Principal Investigator, +86 023-62888436, med@innostellarbio.com
- Recruiting
Southwest Hospital
Chongqing, Chongqing Municipality, 400038
Principal Investigator, +86 023-68754035, med@innostellarbio.com
- Recruiting
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510632
Principal Investigator, +86 020-38688366, med@innostellarbio.com
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
Principal Investigator, +86 0571-85893643, med@innostellarbio.com
- Recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Principal Investigator, +86 0451-86664367, med@innostellarbio.com
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230601
Principal Investigator, +86 0551-62282931, med@innostellarbio.com
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Principal Investigator, +86 0531-82169347, med@innostellarbio.com
- Recruiting
Shandong Eye Hospital
Jinan, Shandong, 250021
Principal Investigator, +86 0531-81276007, med@innostellarbio.com
- Recruiting
The Affiliated Eye Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Principal Investigator, +86 025-86677709, med@innostellarbio.com
- Recruiting
Qingdao Eye Hospital Affiliated to Shandong First Medical University
Qingdao, Shandong, 266071
Principal Investigator, +86 0532-85899231, med@innostellarbio.com
- Recruiting
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031
Principal Investigator, +86 021-34232762, med@innostellarbio.com
- Recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
associate professor, 021-36126255, shiyigcp@126.com
- Recruiting
Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Principal Investigator, +86 021-25078693, med@innostellarbio.com
- Recruiting
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 201801
Principal Investigator, +86 021-64370045, med@innostellarbio.com
- Recruiting
Joint Shantou International Eye Center, Shantou University and the Chinese University of Hong Kong
Shantou, Guangdong, 515041
Principal Investigator, +86 0754-88393516, med@innostellarbio.com
- Recruiting
Shenyang Fourth People's Hospital
Shenyang, Liaoning, 110000
Principal Investigator, +86 024-8620-3666, med@innostellarbio.com
- Recruiting
Shanxi Eye Hospital
Taiyuan, Shanxi, 030002
Principal Investigator, +86 0351-8286926, med@innostellarbio.com
- Recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032
Principal Investigator, +86 0351-8379146, med@innostellarbio.com
- Recruiting
Tianjin Eye Hospital
Tianjin, Tianjin Municipality, 300020
Principal Investigator, +86 022-27313336-80162, med@innostellarbio.com
- Recruiting
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, 300384
professor, 022-86428810, ec_tmueh@126.com
- Recruiting
The Eye Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027
Principal Investigator, +86 0577-88075582, med@innostellarbio.com
- Recruiting
Tongji Hospital Tongji Medical College of HUST
Wuhan, Hubei, 430030
Principal Investigator, +86 027-83691785, med@innostellarbio.com
- Recruiting
Central Theater Command General Hospital of PLA
Wuhan, Hubei, 430060
Principal Investigator, +86 027-50772994, med@innostellarbio.com
- Recruiting
Xi 'an People's Hospital (Xi 'an No.4 Hospital)
Xi’an, Shanxi, 710004
Principal Investigator, +86 029-89623908, med@innostellarbio.com
- Recruiting
The First Affiliated Hospital of Air Force Medical University
Xi’an, Shanxi, 710032
Principal Investigator, +86 029-84771794, med@innostellarbio.com
- Recruiting
Hebei Eye Hospital
Xingtai, Hebei, 054000
Principal Investigator, +86 0319-3237661, med@innostellarbio.com
- Recruiting
Xuzhou First People's Hospital
Xuzhou, Jiangsu, 221002
Principal Investigator, +86 0516-68380774, med@innostellarbio.com
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Zhongshan, Guangdong, 510623
professor, 020-66610720, zoccrc@mail.sysu.edu.cn
About this study
Official title: 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 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.
- Being tested
- LX102, Aflibercept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LX102Genetic
Study eyes will receive a single subretinal injection of LX102.
AfliberceptBiological
Study eyes will receive 3 monthly loading doses of aflibercetp 2mg IVT and aflibercept 2mg IVT every 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| LX102 | Experimental | Not described Receives: Genetic: LX102 |
| Aflibercept | Active comparator | Not described Receives: Biological: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from D0 in BCVA based on an average at weeks 48 and 56.
Mean change from D0 in BCVA as measured by the early treatment diabetic retinopathy study (ETDRS) visual acuity chart based on an average at weeks 48 and 56.
Measured: Week 56
Secondary outcomes (9)
Proportion of participants with improved BCVA
Proportion of participants with improved BCVA at week 56 and week 104
Measured: Week 56 and week 104
Proportion of participants with worsened BCVA
Proportion of participants with worsened BCVA at week 56 and week 104
Measured: Week 56 and week 104
Mean change from D0 in CST based on an average at weeks 48 and 56
Mean change from D0 in central subfield thickness (CST) based on an average at weeks 48 and 56
Measured: Week 56
Proportion of participants without SRF/IRF on OCT at week 56
Proportion of participants without SRF/IRF on OCT at week 56
Measured: Week 56
Proportion of participants who were supplemental anti-VEGF injection-free
Proportion of participants with no supplemental anti-VEGF injection through 56 weeks
Measured: Through 56 weeks
Proportion of participants who received 1 or 2 aflibercept injections
Proportion of participants received ≤2 supplemental anti-VEGF injections through 56 weeks
Measured: Through 56 weeks
Supplemental anti-VEGF injection annualized rate after LX102 administration through Week 56
Mean annualized number of anti-VEGF injections after LX102 administration through 56 weeks.
Measured: Through 56 weeks
Incidence of ocular and nonocular AEs and SAEs
Incidence of Adverse events (AE) and Serious adverse events (SAE) over 56 weeks
Measured: 56 weeks
Immunogenicity characteristics of LX102
Immunogenicity measurements (LX102 randomized participants) ; measure description: Immunogenicity measurements (vector shedding, serum antibodies to AAV2 and serum antibodies to LX102 TP)
Measured: 56 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start14 Jan 2026
- Primary completionMar 2028 (estimated)
- Study completion4 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-Related Macular Degeneration (nAMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 388 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innostellar Biotherapeutics Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317934
- Sponsor's protocol ID
- INNOSTELLAR-LX102A03
- Status last verified
- Aug 2026
- First submitted
- 19 Dec 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No