Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07275840

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai general hospital

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

Location status: Recruiting

Location contact

Xiaodong Sun, Doctor

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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;
  • Other exclusion criteria set by protocol.

Treatment and study plan

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.

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

    Time frame: Week52

Secondary outcomes

  1. The changes in BCVA from baseline at each visit

    Time frame: Baseline,Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52

  2. Proportion of patients with BCVA improvement of ≥0, ≥5, ≥10, and ≥15 ETDRS letters from baseline at week 52

    Time frame: Week52

  3. Proportion of participants with a decrease in BCVA of >0, ≥5, ≥10, and ≥15 ETDRS letters from baseline at week 52

    Time frame: Week52

  4. The change in central subfield thickness of the macula measured by OCT from the baseline at week 52

    Time frame: Week52

  5. Proportion of participants with IRF/SRF/Pigment epithelial detachment (PED) on OCT at Week 52

    Time frame: Week52

  6. Change in choroidal neovascularization (CNV) area on fundus fluorescein angiography (FFA) at week 52 compared to baseline

    Time frame: Week52

  7. Change in CNV leakage area on FFA at week 52 compared to baseline

    Time frame: Week52

  8. Proportion of participants with new-onset MA on OCT at Week 52

    Time frame: Week52

  9. Proportion of new-onset fibrosis on color fundus photography (CFP) at Week 52

    Time frame: Week52

  10. Change in MA area on OCT from baseline at Week 52

    Time frame: Week52

  11. Change in fibrosis area and maximum lesion diameter on CFP from baseline at Week 52

    Time frame: Week52

  12. 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)

    Time frame: From baseline through Week 52

  13. The production of anti-drug antibodies in the serum

    Time frame: Day0、Week4、Week16、Week32、Week48、Week52

Study contacts

Contact information is provided by the study sponsor or research team.

Yating Liu

CONTACT

[email protected]

86 15821084695

Sponsors and collaborators

Lead sponsor

Innovent Biologics Technology Limited (Shanghai R&D Center)

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 10, 2025
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.