Status:
COMPLETED
A Study of Longer Interval of IVT IBI302 in Subjects With nAMD
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
The study is designed for multi-center, randomized, double-masked, active-controlled study to evaluate the longer interval of intravitreal injection of IBI302 in subjects with neovascular age-related ...
Eligibility Criteria
Inclusion
- Willing and able to sign informed consent from and comply with visit and study procedures per protocol.
- Male or female patients≥50 yrs. of age.
- Active subfoveal or parafoveal CNV secondary to neovascular AMD on FFA or OCT.
- The CNV area≥50% lesion area on FFA in the study eye at screening visit.
- BCVA score of 24-78 letters using ETDRS charts in the study eye at the baseline.
Exclusion
- Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results.
- Subretinal hemorrhage\>50% total lesion area and/or involvement in the macular foveal, fibrosis or atrophy area\>50% total lesion area and/or involved of macular fovea;
- Presence of uncontrolled glaucoma in the study eye(defined as IOP≥25mmHg, or judged by the investigators at the screening or baseline visit)
- Presence of active intraocular or periocular inflammation or infection;
- Prior any treatment of following in the study eye:
- Anti-VEGF(Vascular Endothelial Growth Factor) 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 tractive 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
Key Trial Info
Start Date :
June 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2024
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT05403749
Start Date
June 29 2022
End Date
May 13 2024
Last Update
June 28 2024
Active Locations (1)
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1
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, China, 200080