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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This 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 40 and 48.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Willing and able to provide written, signed willing to sign a consent form for this study; 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). Who Should NOT Join This Trial: 1. Any condition in the investigator's opinion that could limit VA improvement in the study eye. 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Willing and able to provide written, signed informed consent for this study; 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: 1. Any condition in the investigator's opinion that could limit VA improvement in the study eye. 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.

Treatments Being Tested

GENETIC

LX102

Study eyes will receive a single subretinal injection of LX102.

BIOLOGICAL

Aflibercept

Study eyes will receive 3 monthly loading doses of aflibercetp 2mg IVT and aflibercept 2mg IVT every 8 weeks.

Locations (20)

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