NCT07275840 A Study to Evaluate the Efficacy and Safety of IBI302inSubjects With nAMD
| NCT ID | NCT07275840 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Innovent Biologics Technology Limited (Shanghai R&D Center) |
| Condition | Neovascular Age-related Macular Degeneration |
| Study Type | INTERVENTIONAL |
| Enrollment | 800 participants |
| Start Date | 2025-12-05 |
| Primary Completion | 2026-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 800 participants in total. It began in 2025-12-05 with a primary completion date of 2026-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07275840 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Neovascular Age-related Macular Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07275840 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07275840 currently recruiting?
Yes, NCT07275840 is actively recruiting participants. Contact the research team at yating.liu@innoventbio.com for enrollment information.
Where is the NCT07275840 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07275840 clinical trial?
NCT07275840 is sponsored by Innovent Biologics Technology Limited (Shanghai R&D Center). The trial plans to enroll 800 participants.