Trial to Evaluate the Safety and Tolerability of Repeated Intravitreal Injection of IBI302 in Neovascular AMD Patients
NCT ID: NCT04370379
Last Updated: 2021-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2020-05-28
2021-05-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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low dose of IBI302
IBI302 (the first dose level)
q4week (3 injections) followed by PRN dosing
high dose of IBI302
IBI302 (the second dose level)
q4week (3 injections) followed by PRN dosing
2mg aflibercept
Aflibercept
2mg, q4week (3 injections) followed by q8week
Interventions
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IBI302 (the first dose level)
q4week (3 injections) followed by PRN dosing
IBI302 (the second dose level)
q4week (3 injections) followed by PRN dosing
Aflibercept
2mg, q4week (3 injections) followed by q8week
Eligibility Criteria
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Inclusion Criteria
2. Active subfoveal or parafoveal CNV secondary to neovascular AMD.
3. Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
Exclusion Criteria
2. Presence of active intraocular or periocular inflammation or infection;
3. History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
4. 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;
5. Diabetic patients have any of the following conditions:HbA1c\>7.5% when screening;
50 Years
ALL
No
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Locations
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Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Countries
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References
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Jia H, Li T, Sun J, Gong Y, Liu H, Wang H, Chen J, Liu W, Lu S, Feng L, Wan Q, Qian L, Wang F, Liu X, Sun X. A Novel Bispecific Fusion Protein Targeting C3b/C4b and VEGF in Patients With nAMD: A Randomized, Open-Label, Phase 1b Study. Am J Ophthalmol. 2023 Apr;248:8-15. doi: 10.1016/j.ajo.2022.11.016. Epub 2022 Nov 21.
Other Identifiers
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CIBI302A102
Identifier Type: -
Identifier Source: org_study_id