A Study to Evaluate the Efficacy and Safety of IBI302inSubjects With nAMD
An Open-label, Multicenter, Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Intravitreal Injection of IBI302 in Participants With Neovascular Age-related Macular Degeneration
Innovent Biologics Technology Limited (Shanghai R&D Center)
800 participants
Dec 5, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- Have signed an informed consent form before participating in the research.
- Male or female individuals aged 50 or above at the time of signing the informed consent form;
- Active CNV under the macular fovea secondary to nAMD or active CNV involving the macular fovea.
- At baseline, the BCVA of the study eye was within the range of 19 to 78 ETDRS letters (including both ends).
Exclusion Criteria9
- 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;
- The study eye has uncontrollable glaucoma;
- There is an active intraocular or periocular infection or inflammation in either eye;
- The non-study eye has severe visual function disorders;
- Within 90 days before baseline, the study eye had received anti-VEGF treatment;
- Within 90 days before baseline, the study eye had received anti-complement treatment;
- At any time before baseline, the study eye had received IBI302 treatment;
- Uncontrollable hypertension;
- Glycated hemoglobin (HbA1c) > 10.0% within 28 days prior to screening;
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07275840