search
Back to results

Evaluation of IBI302 Injection in nAMD or DME

Primary Purpose

Neovascular Age-related Macular Degeneration, Diabetic Macular Edema

Status
Suspended
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Intravitreal injection of IBI302(dose 1)
Intravitreal injection of IBI302(dose 2)
Intravitreal injection of IBI302(dose 3)
Intravitreal injection of Aflibercept
Sponsored by
Innovent Biologics (Suzhou) Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age-related Macular Degeneration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria Willing and able to sign informed consent form and comply with visit and study procedures per protocol; Male or female patiensubjects ≥ 18 yrs. of age; For AMD subjects, active subfoveal or parafoveal CNV secondary to neovascular AMD; the vision decreased by nAMD; For DME subjects, Type 1 or type 2 diabetes mellitus, decrease in vision determined to be primarily the result of DME in the study eye; the CST measurement of ≥ 280 μm in the study eye; BCVA ETDRS letter score of 24-73 in the study eye; Exclusion criteria Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results; Presence of uncontrolled glaucoma in the study eye ; Presence of active intraocular or periocular inflammation or infection; Prior any treatment of following in the study eye: Anti-VEGF therapy or anti-complement therapy; Laser photocoagulation; History of vitreoretinal surgery; Glucocorticoid treatment(intravitreal or peribulbar) ; BCVA score <19 letters in the fellow eye; Anti-VEGF therapy in the fellow eye within 30 days of day 0; Presence of any systemic disease: including but not limited to active infections (such as active viral hepatitis); unstable angina; cerebrovascular accident or transient cerebral ischemia (within 6 months prior to screening); myocardial infarction (within 6 months prior to screening; serious arrhythmia requiring medical treatment; liver, kidney or metabolic diseases; uncontrolled clinical disease(such as diabetes mellitus, hypertension) 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 90 days of day 0, or attempted to participate in other drug trials during the study; Other conditions unsuitable for enrollment judged by investigatiors.

Sites / Locations

  • Peking University People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Aflibercept

IBI302

Arm Description

only phase II

Outcomes

Primary Outcome Measures

Incidence and severity of ocular and non-ocular adverse events.
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.
DLT in each group

Secondary Outcome Measures

Change of BCVA from baseline by visit
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.
Change of CST from baseline by visit
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.
Area under the concentration time curve (AUC) and Maximum plasma concentration (Cmax)
The ADA and neutralizing antibody
Blood samples were obtained for measurement of anti-drug antibodies (ADAs) to IBI302 by a validated enzyme-linked immunosorbent assay (ELISA).

Full Information

First Posted
November 15, 2021
Last Updated
July 17, 2023
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05961007
Brief Title
Evaluation of IBI302 Injection in nAMD or DME
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Suspended
Why Stopped
Company strategy adjustment
Study Start Date
November 18, 2021 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-related Macular Degeneration, Diabetic Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Masking Description
Masking participant and investorgastor
Allocation
Randomized
Enrollment
234 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aflibercept
Arm Type
Active Comparator
Arm Description
only phase II
Arm Title
IBI302
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Intravitreal injection of IBI302(dose 1)
Intervention Description
IBI302(dose 1) intravitreal injection given as protocol
Intervention Type
Biological
Intervention Name(s)
Intravitreal injection of IBI302(dose 2)
Intervention Description
IBI302(dose 2) intravitreal injection given as protocol
Intervention Type
Biological
Intervention Name(s)
Intravitreal injection of IBI302(dose 3)
Intervention Description
IBI302(dose 3) intravitreal injection given as protocol
Intervention Type
Drug
Intervention Name(s)
Intravitreal injection of Aflibercept
Intervention Description
Aflibercept intravitreal injection given as protocol
Primary Outcome Measure Information:
Title
Incidence and severity of ocular and non-ocular adverse events.
Description
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.
Time Frame
Up to week 20
Title
DLT in each group
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Change of BCVA from baseline by visit
Description
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.
Time Frame
through study completion,an average of 20 weeks
Title
Change of CST from baseline by visit
Description
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.
Time Frame
through study completion,an average of 20 weeks
Title
Area under the concentration time curve (AUC) and Maximum plasma concentration (Cmax)
Time Frame
through study completion,an average of 20 weeks
Title
The ADA and neutralizing antibody
Description
Blood samples were obtained for measurement of anti-drug antibodies (ADAs) to IBI302 by a validated enzyme-linked immunosorbent assay (ELISA).
Time Frame
through study completion,an average of 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Willing and able to sign informed consent form and comply with visit and study procedures per protocol; Male or female patiensubjects ≥ 18 yrs. of age; For AMD subjects, active subfoveal or parafoveal CNV secondary to neovascular AMD; the vision decreased by nAMD; For DME subjects, Type 1 or type 2 diabetes mellitus, decrease in vision determined to be primarily the result of DME in the study eye; the CST measurement of ≥ 280 μm in the study eye; BCVA ETDRS letter score of 24-73 in the study eye; Exclusion criteria Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results; Presence of uncontrolled glaucoma in the study eye ; Presence of active intraocular or periocular inflammation or infection; Prior any treatment of following in the study eye: Anti-VEGF therapy or anti-complement therapy; Laser photocoagulation; History of vitreoretinal surgery; Glucocorticoid treatment(intravitreal or peribulbar) ; BCVA score <19 letters in the fellow eye; Anti-VEGF therapy in the fellow eye within 30 days of day 0; Presence of any systemic disease: including but not limited to active infections (such as active viral hepatitis); unstable angina; cerebrovascular accident or transient cerebral ischemia (within 6 months prior to screening); myocardial infarction (within 6 months prior to screening; serious arrhythmia requiring medical treatment; liver, kidney or metabolic diseases; uncontrolled clinical disease(such as diabetes mellitus, hypertension) 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 90 days of day 0, or attempted to participate in other drug trials during the study; Other conditions unsuitable for enrollment judged by investigatiors.
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of IBI302 Injection in nAMD or DME

We'll reach out to this number within 24 hrs