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A Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With nAMD

Primary Purpose

Neovascular Age-related Macular Degeneration

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Aflibercept Ophthalmic
IBI302
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

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

Inclusion Criteria: Signed informed consent must be obtained prior to study participation; Male or female ≥ 50 years of age at the time of signing the informed consent; Active subfoveal CNV secondary to nAMD, or active CNV with intra/subretinal fluid involving the fovea; BCVA of 19 to 78 ETDRS letters (inclusive) in the study eye at baseline. Exclusion Criteria: Ocular disease: Any concurrent intraocular condition/systemic disease in the study eye at screening or baseline that, in the judgment of the investigator, may cause the participant fail to respond to the treatment or confuse the interpretation of study results; Total lesion area(including blood, atrophy, fibrosis, PED and neovascularization)> 12 optic disc area (DA) on FFA; Subretinal hemorrhage area > 50% of the total lesion area, or subretinal hemorrhage area involving macular fovea ≥ 1 DA; Fibrosis or atrophy area > 50% of the total lesion area, or involving the fovea; Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg after standard treatment); Presence of active intraocular or periocular infection or inflammation; Ocular treatment: Anti-VEGF or anti-complement therapy in the study eye within 90 days prior to baseline; Fundus laser photo-coagulation in the study eye within 90 days prior to baseline; Photodynamic Therapy (PDT) in the study eye within 90 days prior to baseline; History of vitreoretinal surgery, penetrating keratoplasty in the study eye; General condition or treatment: Uncontrolled hypertension (defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg after standard treatment); HbA1c > 8% within 28 days prior to baseline; Systemic anti-VEGF drug and anti-complement drug therapy within 90 days prior to baseline; History of hypersensitivity to any component of the test article, control article, or clinically relevant sensitivity to fluorescein dye, povidone-iodine; Pregnant or lactating women; Inappropriate for the study (e.g., substance abuse, inability or unwillingness to follow the trial protocol), as judged by the investig.

Sites / Locations

  • Innovent Biologics (Suzhou) Co,Ltd.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Aflibercept

IBI302 dose 8mg

Arm Description

Drug: Aflibercept 2mg/eye; Intraocular injection

Drug: IBI302 8mg/eye; Intraocular injection

Outcomes

Primary Outcome Measures

Mean change from baseline in BCVA score at Week 44, 48, and 52 for the study eye.

Secondary Outcome Measures

The proportion of participants with absence intraretinal fluid (IRF) and absence subretinal fluid (SRF) in the fovea at Week 16
The intraretinal fluid and subretinal fluid is measured by optical coherence tomography (OCT) in the central subfield(center 1 millimeter)
Change from baseline in BCVA at Week 52 and 100
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 from baseline in central subfield thickness (CST) measured by optical coherence tomography (OCT) at Week 52 and 100
Central subfield thickness was defined as the distance between the internal limiting member and the Bruch's member using OCT, as assessed by the central reading center.
Change from baseline in area of CNV on fundus fluorescence angiography (FFA) at Week 52 and 100
the area of the choroidal neovascularization lesion in the study eye was measured by a central reading center using FFA
Proportion of participants on a q8W, q12W, and q16W treatment intervals at Week 52 and 100
Percentages are based on number of participants randomized to the IBI302 group who have not discontinued the study at week 52 and 100. the treatment interval at a givven visit is defined as the treatment interval decision followed at that visit.
Incidence, relatedness to the study drug and severity of ocular and Non-ocular adverse events (AE), treatment emergent adverse events (TEAE) and serious adverse events (SAE).
All AEs were recorded and the investigator made an assessment of seriousness,severity, and causality of each AE.

Full Information

First Posted
July 25, 2023
Last Updated
July 25, 2023
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05972473
Brief Title
A Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With nAMD
Official Title
A Phase 3, Randomized, Double-masked, Active-Controlled Study to Evaluate the Efficacy and Safety of Intravitreal IBI302(Efdamrofusp Alfa) in Subjects With Neovascular Age-Related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 15, 2023 (Anticipated)
Primary Completion Date
February 28, 2027 (Anticipated)
Study Completion Date
April 30, 2027 (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 study is designed for multi-center,randomized,double-masked,active-contralled study to evaluate effective and security of intravitreal injection of IBI302 in subjects with neovascular age-related macular degeneration.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aflibercept
Arm Type
Active Comparator
Arm Description
Drug: Aflibercept 2mg/eye; Intraocular injection
Arm Title
IBI302 dose 8mg
Arm Type
Experimental
Arm Description
Drug: IBI302 8mg/eye; Intraocular injection
Intervention Type
Drug
Intervention Name(s)
Aflibercept Ophthalmic
Intervention Description
2mg Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive monthes, folloesd by once every 8 weeks(Q8W).
Intervention Type
Biological
Intervention Name(s)
IBI302
Intervention Description
8 mg IBI302 will be administered by intraitreal injection into the study eye at intervals as specified in the study protocol.
Primary Outcome Measure Information:
Title
Mean change from baseline in BCVA score at Week 44, 48, and 52 for the study eye.
Time Frame
At week 44, 48, 52
Secondary Outcome Measure Information:
Title
The proportion of participants with absence intraretinal fluid (IRF) and absence subretinal fluid (SRF) in the fovea at Week 16
Description
The intraretinal fluid and subretinal fluid is measured by optical coherence tomography (OCT) in the central subfield(center 1 millimeter)
Time Frame
At week 16
Title
Change from baseline in BCVA at Week 52 and 100
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
Upto Week 100
Title
Change from baseline in central subfield thickness (CST) measured by optical coherence tomography (OCT) at Week 52 and 100
Description
Central subfield thickness was defined as the distance between the internal limiting member and the Bruch's member using OCT, as assessed by the central reading center.
Time Frame
Upto Week 100
Title
Change from baseline in area of CNV on fundus fluorescence angiography (FFA) at Week 52 and 100
Description
the area of the choroidal neovascularization lesion in the study eye was measured by a central reading center using FFA
Time Frame
Upto Week 100
Title
Proportion of participants on a q8W, q12W, and q16W treatment intervals at Week 52 and 100
Description
Percentages are based on number of participants randomized to the IBI302 group who have not discontinued the study at week 52 and 100. the treatment interval at a givven visit is defined as the treatment interval decision followed at that visit.
Time Frame
Upto Week 100
Title
Incidence, relatedness to the study drug and severity of ocular and Non-ocular adverse events (AE), treatment emergent adverse events (TEAE) and serious adverse events (SAE).
Description
All AEs were recorded and the investigator made an assessment of seriousness,severity, and causality of each AE.
Time Frame
Upto Week 100

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent must be obtained prior to study participation; Male or female ≥ 50 years of age at the time of signing the informed consent; Active subfoveal CNV secondary to nAMD, or active CNV with intra/subretinal fluid involving the fovea; BCVA of 19 to 78 ETDRS letters (inclusive) in the study eye at baseline. Exclusion Criteria: Ocular disease: Any concurrent intraocular condition/systemic disease in the study eye at screening or baseline that, in the judgment of the investigator, may cause the participant fail to respond to the treatment or confuse the interpretation of study results; Total lesion area(including blood, atrophy, fibrosis, PED and neovascularization)> 12 optic disc area (DA) on FFA; Subretinal hemorrhage area > 50% of the total lesion area, or subretinal hemorrhage area involving macular fovea ≥ 1 DA; Fibrosis or atrophy area > 50% of the total lesion area, or involving the fovea; Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg after standard treatment); Presence of active intraocular or periocular infection or inflammation; Ocular treatment: Anti-VEGF or anti-complement therapy in the study eye within 90 days prior to baseline; Fundus laser photo-coagulation in the study eye within 90 days prior to baseline; Photodynamic Therapy (PDT) in the study eye within 90 days prior to baseline; History of vitreoretinal surgery, penetrating keratoplasty in the study eye; General condition or treatment: Uncontrolled hypertension (defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg after standard treatment); HbA1c > 8% within 28 days prior to baseline; Systemic anti-VEGF drug and anti-complement drug therapy within 90 days prior to baseline; History of hypersensitivity to any component of the test article, control article, or clinically relevant sensitivity to fluorescein dye, povidone-iodine; Pregnant or lactating women; Inappropriate for the study (e.g., substance abuse, inability or unwillingness to follow the trial protocol), as judged by the investig.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yating Liu
Phone
15821084695
Email
yating.liu@innoventbio.com
Facility Information:
Facility Name
Innovent Biologics (Suzhou) Co,Ltd.
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215123
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yating Liu
Phone
15821084695
Email
yating.liu@innoventbio.com

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With nAMD

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