IBI302 treatment for neovascular age-related macular degeneration

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shanghai general hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Yating Liu
• Email: yating.liu@innoventbio.com
• Phone: 86 15821084695

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.