Status:
COMPLETED
A Study of IBI302 in Patients With nAMD
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
This is a multi-center, randomized, double-blind, active-controlled study to evaluate the efficacy and safety of IBI302 in subjects with neovascular age-related macular degeneration.
Eligibility Criteria
Inclusion
- Inclusion criteria
- Male or female patient ≥ 50 yrs. of age.
- Active subfoveal or parafoveal CNV secondary to neovascular AMD.
- BCVA score of 24-73 letters using ETDRS charts in the study eye.
- Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
- Exclusion criteria
- Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results;
- Presence of uncontrolled glaucoma in the study eye (defined as IOP≥25mmHg despite the standardized treatment);
- Presence of active intraocular or periocular inflammation or infection;
- Prior any treatment of following in the study eye:
- Anti-VEGF therapy or anti-complement therapy within 3 months prior to screening;
- Laser photocoagulation within 3 months prior to screening;
- Photodynamic therapy or vitreoretinal surgery;
- Intraocular glucocorticoid injection within 6 months prior to enrollment;
- Presence of any systemic disease: including but not limited toactive infections (such as active viral hepatitis); unstable angina; cerebrovascular accident or transient cerebral ischemia (within 6 months prior to selection); myocardial infarction (within 6 months prior to selection); serious arrhythmia requiring medical treatment; liver, kidney or metabolic diseases; or malignant tumor;
- History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
- Pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period;
- Participated in any clinical study of any other drug within three months prior to enrollment, or attempted to participate in other drug trials during the study;
- Other conditions unsuitable for enrollment judged by investigators
Exclusion
Key Trial Info
Start Date :
April 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2023
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT04820452
Start Date
April 28 2021
End Date
January 13 2023
Last Update
November 18 2024
Active Locations (1)
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1
Innovent Biologics (Suzhou) Co,Ltd.
Suzhou, Jiangsu, China, 215123