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

NCT07275840 | Recruiting Phase 2

• 1 other identifier: CIBI302A203
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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

Study Arms (1)

IBI302 8mg dose 8mg

EXPERIMENTAL

Drug: IBI302 8mg/Intravitreal injection

Drug: IBI302 8mg dose

Interventions

IBI302 8mg dose 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.

IBI302 8mg dose 8mg

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

Shanghai general hospital

Shanghai, Shanghai Municipality, P. R. China 200080, China

RECRUITING

MeSH Terms

Interventions

IBI302

Central Study Contacts

Yating Liu

CONTACT

86 15821084695; yating.liu@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 10, 2025
• Study Start: December 5, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

CN (1)