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

Innovent Biologics Technology Limited (Shanghai R&D Center)

Status and phase: Enrolling; Phase 2

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Drug: IBI302 8mg dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT07275840

CIBI302A203

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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800 participants in 1 patient group

IBI302 8mg dose 8mg

Experimental group

Description:

Drug: IBI302 8mg/Intravitreal injection

Treatment:

Drug: IBI302 8mg dose