Actively Recruiting
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
Led by Innovent Biologics Technology Limited (Shanghai R&D Center) · Updated on 2026-01-08
800
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of IBI302 given by intravitreal injection in patients with neovascular age-related macular degeneration (nAMD). This open-label, multicenter, single-arm Phase II trial focuses on people aged 50 and older who have active choroidal neovascularization affecting the macular fovea. The study aims to understand how well visual acuity is preserved over time with this treatment. Participants will receive an 8 mg dose of IBI302 injected into the study eye once every 4 weeks for the first 3 months, followed by injections every 8 weeks thereafter. This treatment schedule is designed to assess the drug's impact over a 52-week period. The trial does not include a comparison or placebo group and involves a single treatment arm. During the study, participants will have their best corrected visual acuity (BCVA) tested regularly, along with eye imaging using OCT and fundus fluorescein angiography to monitor changes in the retina and choroidal neovascularization. Researchers will also track adverse events and the development of anti-drug antibodies. The main outcome is the proportion of participants whose BCVA decreases by less than 15 letters from baseline at week 52. Follow-up assessments will occur at multiple visits throughout the year-long study.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy and Safety of IBI302inSubjects With nAMD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before participation
- Male or female aged 50 years or older at consent
- Active choroidal neovascularization under or involving the macular fovea due to neovascular age-related macular degeneration
- Best corrected visual acuity in the study eye between 19 and 78 ETDRS letters at baseline
You will not qualify if you...
- Ocular or systemic diseases in the study eye that may affect treatment response or study results
- Uncontrollable glaucoma in the study eye
- Active intraocular or periocular infection or inflammation in either eye
- Severe visual function disorders in the non-study eye
- Anti-VEGF treatment in the study eye within 90 days before baseline
- Anti-complement treatment in the study eye within 90 days before baseline
- Prior IBI302 treatment in the study eye at any time before baseline
- Uncontrollable hypertension
- Glycated hemoglobin (HbA1c) greater than 10.0% within 28 days before screening
- Other exclusion criteria as defined by the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants receive intravitreal injections of IBI302 8mg into the study eye once every 4 weeks for 3 months, followed by injections once every 8 weeks.
Monthly visits for the first 3 months, then visits every 8 weeks thereafter
Trial Site Locations
Total: 1 location
1
Shanghai general hospital
Shanghai, Shanghai Municipality, China, P. R. China 200080
Actively Recruiting
Research Team
Y
Yating Liu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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