๐ฌIn plain words
What the trial is, and whether it could suit you
The goal of this study is to evaluate the safety and efficacy of LX111 treatment of nAMD. This study will enroll subjects aged โฅ 50 vears old to receive a single unilateral intravitreal (lVT) injection of LX111 to evaluate its safety and efficacy.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
1. Willing to sign the informed consent, and willing to attend follow-up visits.
2. Age โฅ 50
3. Diagnosis of active CNV secondary to neovascular AMD
4. BCVA ETDRS letters between 5 and 63
5. Subjects must have received a minimum of 2 injections within 6 months prior to screening and demonstrated a meaningful response to anti-VEGF therapy
6. Male subjects whose partner is a fertile female or female subjects who are fertile, agree to take effective contraceptive measures from the screening period until the last follow-up.
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. Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months
4. Uncontrolled hypertension defined as average SBP โฅ160 mmHg or an average DBP โฅ100 mmHg
5. Uncontrolled diabetes defined as HbA1c \>8.0% within 28 days prior to screening
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.