A Dose Escalation Study to Evaluate the Safety and Tolerability of IBI302 Intravitreal Injection in Subjects With Neovascular Age-related Macular Degeneration and Diabetic Macular Edema AND A Multi-center, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With Diabetic Macular Edema
Overview
- Phase
- Phase 1
- Intervention
- Intravitreal injection of IBI302(dose 3)
- Conditions
- Neovascular Age-related Macular Degeneration
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Enrollment
- 234
- Locations
- 1
- Primary Endpoint
- DLT in each group
- Status
- Suspended
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to determine the efficacy and safety of intravitreal IBI302 in the treatment of subjects with neovascular age-related macular degeneration (only in Phase I) or diabetic macular edema.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
IBI302
Intervention: Intravitreal injection of IBI302(dose 3)
IBI302
Intervention: Intravitreal injection of IBI302(dose 1)
IBI302
Intervention: Intravitreal injection of IBI302(dose 2)
Aflibercept
only phase II
Intervention: Intravitreal injection of Aflibercept
Outcomes
Primary Outcomes
DLT in each group
Time Frame: 7 days
Incidence and severity of ocular and non-ocular adverse events.
Time Frame: Up to week 20
To evaluate the number of subjects with ocular and non-ocular adverse events, treatment emergent adverse event, adverse event of special interest, serious adverse events; number of subjects with clinical significant abnormal laboratory values, electrocardiograms (pre and post infusions), abnormal vital signs, ophthalmic and physical examinations.
Secondary Outcomes
- Change of CST from baseline by visit(through study completion，an average of 20 weeks)
- The ADA and neutralizing antibody(through study completion，an average of 20 weeks)
- Change of BCVA from baseline by visit(through study completion，an average of 20 weeks)
- Area under the concentration time curve (AUC) and Maximum plasma concentration (Cmax)(through study completion，an average of 20 weeks)