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

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.

Study Overview

• Status: Recruiting
• Conditions: Neovascular Age-related Macular Degeneration
• Intervention / Treatment: Drug: IBI302 8mg dose

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yating Liu; Phone Number: 86 15821084695; Email: yating.liu@innoventbio.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, P. R. China 200080
      • Recruiting
      • Shanghai General Hospital
      • Principal Investigator: Xiaodong Sun, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBI302 8mg dose 8mg; Drug: IBI302 8mg/Intravitreal injection	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
The changes in BCVA from baseline at each visit	Baseline，Weeks 4，8，12，16，20，24，28，32，36，40，44，48 and 52
Proportion of patients with BCVA improvement of ≥0, ≥5, ≥10, and ≥15 ETDRS letters from baseline at week 52	Week52
Proportion of participants with a decrease in BCVA of >0, ≥5, ≥10, and ≥15 ETDRS letters from baseline at week 52	Week52
The change in central subfield thickness of the macula measured by OCT from the baseline at week 52	Week52
Proportion of participants with IRF/SRF/Pigment epithelial detachment (PED) on OCT at Week 52	Week52
Change in choroidal neovascularization (CNV) area on fundus fluorescein angiography (FFA) at week 52 compared to baseline	Week52
Change in CNV leakage area on FFA at week 52 compared to baseline	Week52
Proportion of participants with new-onset MA on OCT at Week 52	Week52
Proportion of new-onset fibrosis on color fundus photography (CFP) at Week 52	Week52
Change in MA area on OCT from baseline at Week 52	Week52
Change in fibrosis area and maximum lesion diameter on CFP from baseline at Week 52	Week52
The incidence rate, correlation with the studied drugs, and severity of ocular and systemic adverse events (AE), treatment emergent adverse events (TEAE), and serious adverse events (SAE)	From baseline through Week 52
The production of anti-drug antibodies in the serum	Day0、Week4、Week16、Week32、Week48、Week52

Collaborators and Investigators

• Sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center)

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Estimated): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: IBI302
• Other Study ID Numbers: CIBI302A203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No