Status:
COMPLETED
Trial to Evaluate the Safety and Tolerability of Repeated Intravitreal Injection of IBI302 in Neovascular AMD Patients
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief Summary
This study is designed for multi-center, open-label, randomized, dose escalation phase I trial to evaluate the safety and tolerability of a multiple dose intravitreal injection of IBI302 in neovascula...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Inclusion criteria
- Male or female patient ≥ 50 yrs. of age.
- Active subfoveal or parafoveal CNV secondary to neovascular AMD.
- Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
- Exclusion criteria
- Presence of uncontrolled glaucoma in the study eye (defined as IOP≥30mmHg despite the standardized treatment);
- Presence of active intraocular or periocular inflammation or infection;
- History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
- 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;
- Diabetic patients have any of the following conditions:HbA1c\>7.5% when screening;
Exclusion
Key Trial Info
Start Date :
May 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2021
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04370379
Start Date
May 28 2020
End Date
May 8 2021
Last Update
November 11 2021
Active Locations (1)
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1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080