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

NCT ID: NCT07275840

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-05
• Study Completion Date: 2026-08-30

Brief 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.

Conditions

Neovascular Age-related Macular Degeneration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IBI302 8mg dose 8mg

Drug: IBI302 8mg/Intravitreal injection

Group Type: EXPERIMENTAL

IBI302 8mg dose

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics Technology Limited (Shanghai R&D Center)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai general hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yating Liu

Role: CONTACT

yating.liu@innoventbio.com

86 15821084695

Other Identifiers

CIBI302A203

Identifier Type: -

Identifier Source: org_study_id