Evaluation of IBI302 Injection in nAMD or DME

Phase 1

Suspended

• Conditions: Neovascular Age-related Macular Degeneration; Diabetic Macular Edema
• Interventions: Drug: Intravitreal injection of Aflibercept; Biological: Intravitreal injection of IBI302(dose 1); Biological: Intravitreal injection of IBI302(dose 2); Biological: Intravitreal injection of IBI302(dose 3)

• Registration Number: NCT05961007
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-15
• Study Start: 2021-11-18
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-17
• Last Update Submitted: 2023-07-17
• Study First Posted: 2023-07-27
• Last Update Posted: 2023-07-27
• Primary Completion: 2023-10-31
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Aflibercept	Intravitreal injection of Aflibercept	only phase II
IBI302	Intravitreal injection of IBI302(dose 1)	-
IBI302	Intravitreal injection of IBI302(dose 3)	-
IBI302	Intravitreal injection of IBI302(dose 2)	-

Primary Outcome Measures

Name	Time	Method
DLT in each group	7 days
Incidence and severity of ocular and non-ocular adverse events.	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 Outcome Measures

Name	Time	Method
Change of CST from baseline by visit	through study completion，an average of 20 weeks	Central subfield thickness（CST） was defined as the distance between the internal limiting member and the Bruch's member using OCT, as assessed by the central reading.
The ADA and neutralizing antibody	through study completion，an average of 20 weeks	Blood samples were obtained for measurement of anti-drug antibodies (ADAs) to IBI302 by a validated enzyme-linked immunosorbent assay (ELISA).
Change of BCVA from baseline by visit	through study completion，an average of 20 weeks	Best corrected visual acuity (BCVA) was measured on early treatment diabetic retinopathy study(ETDRS) chart at a starting distance of 4 meters. The BCVAletter score ranges from 0 to 100(best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
Area under the concentration time curve (AUC) and Maximum plasma concentration (Cmax)	through study completion，an average of 20 weeks

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China