NCT07317934RecruitingPhase 3
Efficacy and Safety of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (STELLAR)
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
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 388 (estimated)
- First submitted
- 19 Dec 2025
- Start date
- 14 Jan 2026
- Primary completion date
- Mar 2028
- Lead sponsor
- Innostellar Biotherapeutics Co.,Ltd
- Diseases
- Macular degeneration
- NCT number
- NCT07317934
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 388
- From 14 Jan 2026 to the primary completion date, Mar 2028
- 36 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of intraocular surgery within 1 month before screening in the study eye;
Other illness
- Any condition in the investigator's opinion that could limit VA improvement in the study eye.
- History of retinal detachment in the study eye at any time;
- History of idiopathic or autoimmune uveitis in either eye;
- History of vitrectomy surgery 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.
Other
- 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;
- Advanced glaucoma in the study eye;
Who the study is looking for
- 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.
Age in the registry: 50 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (36)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing Aier-Intech Eye Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The Second Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
| Aier Eye Hospital Group Co., LTD. Changsha Aier Eye Hospital Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| The Second Xiangya Hospital, Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Sichuan Provincial People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| The Second Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| Southwest Hospital Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| The First Affiliated Hospital of Jinan University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Zhejiang Provincial People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The Second Affiliated Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Harbin | China | Recruiting |
| The First Affiliated Hospital of University of Science and Technology of China Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Shandong Eye Hospital Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| The Affiliated Eye Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Qingdao Eye Hospital Affiliated to Shandong First Medical University Coordinator of this site? Confirm its status | Qingdao | China | Recruiting |
| Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Eye ENT Hospital of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanghai General Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Xinhua Hospital Affiliated To Shanghai Jiao tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Joint Shantou International Eye Center, Shantou University and the Chinese University of Hong Kong Coordinator of this site? Confirm its status | Shantou | China | Recruiting |
| Shenyang Fourth People's Hospital Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
| Shanxi Bethune Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Recruiting |
| Shanxi Eye Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Recruiting |
| Tianjin Eye Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| Tianjin Medical University Eye Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| The Eye Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Recruiting |
| Central Theater Command General Hospital of PLA Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Tongji Hospital Tongji Medical College of Hust Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Xi 'an People's Hospital (Xi 'an No.4 Hospital) Coordinator of this site? Confirm its status | Xi’an | China | Recruiting |
| The First Affiliated Hospital of Air Force Medical University Coordinator of this site? Confirm its status | Xi’an | China | Recruiting |
| Hebei Eye Hospital Coordinator of this site? Confirm its status | Xingtai | China | Recruiting |
| Xuzhou First People's Hospital Coordinator of this site? Confirm its status | Xuzhou | China | Recruiting |
| Zhongshan Ophthalmic Center, Sun Yat-sen University Coordinator of this site? Confirm its status | Zhongshan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.