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Efficacy and Safety of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (STELLAR)

RecruitingPhase 3Ages 50 Years - 80 YearsAllInnostellar Biotherapeutics Co.,Ltd
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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. 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 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.
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What it tests

  • LX102
  • Aflibercept
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Where

36 sites
The First Affiliated Hospital of University of Science and Technology of China
Hefei, China
Beijing Aier-Intech Eye Hospital
Beijing, China
Beijing Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
Southwest Hospital
Chongqing, China
The First Affiliated Hospital of Jinan University
Guangzhou, China
Joint Shantou International Eye Center, Shantou University and the Chinese University of Hong Kong
Shantou, China

…and 28 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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