Aflibercept intravitreal injection: Commercially available Active Comparator
Study summary
The goal of this study is to evaluate the overall safety and efficacy of LX102 gene therapy for nAMD.
Eligibility
Sex
ALL
Min age
50 Years
Max age
89 Years
Healthy volunteers
No
Inclusion Criteria:
1. Willing to sign the informed consent, and willing to attend follow-up visits.
2. Age ≥ 50, and ≤ 89.
3. Diagnosis of active CNV secondary to neovascular AMD.
4. BCVA ETDRS letters between 19 and 73.
5. Demonstrated a meaningful response to anti-VEGF therapy.
Exclusion Criteria:
1. CNV or macular edema in the study eye secondary to diseases other than nAMD.
2. Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement.
3. Absence of RPE tear at Screening.
4. Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months.
5. Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg.
6. Uncontrolled diabetes defined as HbA1c \>8.0%.
Primary outcome measure(s)
Mean change from baseline in Best Corrected Visual Acuity (BCVA) — 36 weeks BCVA measured by ETDRS
Trial sites (11)
Facility
City
Region
Status
Anhui Provincial Hospital
Hefei
Anhui
Zhejiang University Eye Hospital
Hangzhou
Zhejiang
Peking Union Medical College Hospital
Beijing
China
West China Hospital of Sichuan University
Chengdu
China
Guangzhou Aier Eye Hospital
Guangzhou
China
Zhongshan Ophthalmic Center of Sun Yat-Sen University
Guangzhou
China
Shanghai Eye and ENT Hospital
Shanghai
China
Shanghai General Hospital
Shanghai
China
Shanxi Eye Hospital
Taiyuan
China
Tianjin Medical University Eye Hospital
Tianjin
China
Xuzhou No.1 People's Hospital
Xuzhou
China
More Innostellar Biotherapeutics Co.,Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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