IBI302 8mg dose: 8 mg IBI302 will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks.
Study summary
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.
Eligibility
Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Proportion of participants whose best corrected visual acuity (BCVA) of the study eye decreased by less than 15 letters from baseline as measured by the visual acuity chart in the early treatment diabetic retinopathy study (ETDRS) at week 52 — Week52
Trial sites (1)
Facility
City
Region
Status
Shanghai general hospital
Shanghai
Shanghai Municipality
Recruiting
More Innovent Biologics Technology Limited (Shanghai R&D Center) 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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