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A Study to Evaluate the Efficacy and Safety of IBI302inSubjects With nAMD

RecruitingPhase 2Ages 50 Years - anyAllInnovent Biologics Technology Limited (Shanghai Rโ€ฆ
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In plain words

What the trial is, and whether it could suit you

This study is designed for Open-label, multi-center, single-arm Phase II trail to evaluate the efficacy and safety of intravitreal injection of IBI302 in nAMD patients.

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

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Have signed an informed consent form before participating in the research. 2. Male or female individuals aged 50 or above at the time of signing the informed consent form; 3. Active CNV under the macular fovea secondary to nAMD or active CNV involving the macular fovea. 4. At baseline, the BCVA of the study eye was within the range of 19 to 78 ETDRS letters (including both ends). Exclusion Criteria: 1. According to the investigator's judgment, concomitant ocular diseases/systemic diseases of the study eyes at screening or baseline may lead to participants' non-response to the study treatment or confuse the interpretation of the study results; 2. The study eye has uncontrollable glaucoma; 3. There is an active intraocular or periocular infection or inflammation in either eye; 4. The non-study eye has severe visual function disorders; 5. Within 90 days before baseline, the study eye had received anti-VEGF treatment; 6. Within 90 days before baseline, the study eye had received anti-complement treatment; 7. At any time before baseline, the study eye had received IBI302 treatment; 8. Uncontrollable hypertension; 9. Glycated hemoglobin (HbA1c) \> 10.0% within 28 days prior to screening; 10. Other exclusion criteria set by protocol.
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What it tests

  • IBI302 8mg dose
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Where

1 site
Shanghai general hospital
Shanghai, China
๐Ÿค 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.
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