IBI302 treatment for neovascular age-related macular degeneration

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 trial will try intravitreal 8 mg IBI302 injections to see if they help people aged 50 and older with active neovascular (wet) AMD.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 800 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center) (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07275840 on ClinicalTrials.gov

What this trial studies

This is an open-label, multicenter, single-arm Phase II trial administering intravitreal IBI302 (8 mg) to patients with active choroidal neovascularization involving the macular fovea from nAMD. Eligible participants are aged 50 or older with baseline BCVA between 19 and 78 ETDRS letters and without recent anti-VEGF treatment in the study eye. Efficacy will be monitored by changes in visual acuity and retinal imaging, and safety will be tracked through ocular exams and adverse event reporting. The study is led by Innovent Biologics at Shanghai General Hospital.

Who should consider this trial

Good fit: Ideal candidates are adults 50 or older with active CNV under or involving the macular fovea and baseline BCVA of 19–78 ETDRS letters who have not had anti-VEGF treatment in the study eye within 90 days.

Not a fit: Patients with uncontrollable glaucoma, active intraocular or periocular infection or inflammation, significant comorbid ocular/systemic disease that may confound results, or other severe visual disorders in the non-study eye are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, IBI302 could provide an additional intravitreal option to improve or stabilize vision in patients with active nAMD.

How similar studies have performed: Established intravitreal anti-VEGF therapies are effective for nAMD, and novel or bispecific biologics like IBI302 are an emerging approach with limited but encouraging early-phase data.

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;
10. Other exclusion criteria set by protocol.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai general hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yating Liu

Conditions Neovascular Age-related Macular Degeneration