Back to resultsA Study of Longer Interval of IVT IBI302 in Subjects With nAMD
Primary Purpose
Neovascular Age-related Macular Degeneration
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
dose 1 IBI302
Aflibercept
dose 2 IBI302
Sponsored by
About this trial
This is an interventional treatment trial for Neovascular Age-related Macular Degeneration
Eligibility Criteria
Inclusion Criteria:
- Willing and able to sign informed consent from and comply with visit and study procedures per protocol.
- Male or female patients≥50 yrs. of age.
- Active subfoveal or parafoveal CNV secondary to neovascular AMD on FFA or OCT.
- The CNV area≥50% lesion area on FFA in the study eye at screening visit.
- BCVA score of 24-78 letters using ETDRS charts in the study eye at the baseline.
Exclusion Criteria:
- Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results.
- Subretinal hemorrhage>50% total lesion area and/or involvement in the macular foveal, fibrosis or atrophy area>50% total lesion area and/or involved of macular fovea;
- Presence of uncontrolled glaucoma in the study eye(defined as IOP≥25mmHg, or judged by the investigators at the screening or baseline visit)
- 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 within 3 months prior to screening;
- Laser photocoagulation within 3 months prior to screening;
- Photodynamic therapy or vitreoretinal surgery;
- Intraocular glucocorticoid injection within 6 months prior to enrollment;
- Presence of any systemic disease: including but not limited tractive infections (such as active viral hepatitis); unstable angina; cerebrovascular accident or transient cerebral ischemia (within 6 months prior to selection); myocardial infarction (within 6 months prior to selection); serious arrhythmia requiring medical treatment; liver, kidney or metabolic diseases; 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 three months prior to enrollment, or attempted to participate in other drug trials during the study;
- Other conditions unsuitable for enrollment judged by investigators
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
IBI302 dose 2 group
Aflibercept
IBI302 dose 1 group
Arm Description
Drug: Aflibercept 8mg/eye;Intraocular injection
Drug: Aflibercept 2mg/eye;Intraocular injection
Drug: Aflibercept 6.4mg/eye;Intraocular injection
Outcomes
Primary Outcome Measures
Percentage of Participants Gaining ≥0,5,10,15 Letters From the Baseline BCVA in the Study Eye Over Time
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
Secondary Outcome Measures
Percentage of Participants Loss >0,≥5,10，15 Letters From the Baseline BCVA in the Study Eye Over Time
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a loss in BCVA letter score from baseline indicates a decline in visual acuity.
Change of Central Subfield Thickness in the Study Eye from baseline
Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane using optical coherence tomography (OCT), as assessed by the central reading center.
Change of Total Area of Choroidal Neovascularization Lesion/Total Area of Choroidal Neovascularization Leakage in the Study Eye from Baseline
The total area of the choroidal neovascularization lesion/Total Area of Choroidal Neovascularization Leakage in the study eye was evaluated by a central reading center using fundus fluorescein angiography (FFA).
Percentage of Participants in different dosage of IBI302 Arm on Once Every 8-Weeks, 12-Weeks,Treatment Intervals
Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants
This safety summary reports the number and percentage of participants who experienced at least one adverse event (AE) during the study. AEs are categorized as any AEs, ocular AEs occurring in the study eye or fellow eye, systemic AEs, serious AEs, AEs related to treatment with study drug, AEs of special interest. The investigator independently assessed the seriousness and severity for each AE. Severity was graded according to the following grading scale: Mild = Discomfort noticed, but no disruption of normal daily activity; Moderate = Discomfort sufficient to reduce or affect normal daily activity; Severe = Incapacitating with inability to work or to perform normal daily activity.
Full Information
NCT ID
NCT05403749
First Posted
May 20, 2022
Last Updated
May 26, 2022
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05403749
Brief Title
A Study of Longer Interval of IVT IBI302 in Subjects With nAMD
Official Title
A Multi-center, Randomized, Double-masked, Active-controlled Study to Evaluate the Longer Interval of Intravitreal Injection of IBI302 in Subjects With Neovascular Age-related Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 15, 2022 (Anticipated)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
June 1, 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 study is designed for multi-center, randomized, double-masked, active-controlled study to evaluate the longer interval 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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IBI302 dose 2 group
Arm Type
Experimental
Arm Description
Drug: Aflibercept 8mg/eye;Intraocular injection
Arm Title
Aflibercept
Arm Type
Active Comparator
Arm Description
Drug: Aflibercept 2mg/eye;Intraocular injection
Arm Title
IBI302 dose 1 group
Arm Type
Experimental
Arm Description
Drug: Aflibercept 6.4mg/eye;Intraocular injection
Intervention Type
Biological
Intervention Name(s)
dose 1 IBI302
Intervention Description
After 4 loading monthly intravitreal injections of dose 1 IBI302，the following IBI302 IVT is given as descript in protocol.
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Intervention Description
Three consecutive monthly intravitreal injections of 2.0mg Aflibercept followed by injection every other month
Intervention Type
Biological
Intervention Name(s)
dose 2 IBI302
Intervention Description
After 4 loading monthly intravitreal injections of dose 2 IBI302，the following IBI302 IVT is given as descript in protocol
Primary Outcome Measure Information:
Title
Percentage of Participants Gaining ≥0,5,10,15 Letters From the Baseline BCVA in the Study Eye Over Time
Description
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
Time Frame
From Baseline to week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants Loss >0,≥5,10，15 Letters From the Baseline BCVA in the Study Eye Over Time
Description
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a loss in BCVA letter score from baseline indicates a decline in visual acuity.
Time Frame
Baseline to week 52
Title
Change of Central Subfield Thickness in the Study Eye from baseline
Description
Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane using optical coherence tomography (OCT), as assessed by the central reading center.
Time Frame
Baseline to week 52
Title
Change of Total Area of Choroidal Neovascularization Lesion/Total Area of Choroidal Neovascularization Leakage in the Study Eye from Baseline
Description
The total area of the choroidal neovascularization lesion/Total Area of Choroidal Neovascularization Leakage in the study eye was evaluated by a central reading center using fundus fluorescein angiography (FFA).
Time Frame
From Baseline to week 52
Title
Percentage of Participants in different dosage of IBI302 Arm on Once Every 8-Weeks, 12-Weeks,Treatment Intervals
Time Frame
At Week 20,40,52
Title
Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants
Description
This safety summary reports the number and percentage of participants who experienced at least one adverse event (AE) during the study. AEs are categorized as any AEs, ocular AEs occurring in the study eye or fellow eye, systemic AEs, serious AEs, AEs related to treatment with study drug, AEs of special interest. The investigator independently assessed the seriousness and severity for each AE. Severity was graded according to the following grading scale: Mild = Discomfort noticed, but no disruption of normal daily activity; Moderate = Discomfort sufficient to reduce or affect normal daily activity; Severe = Incapacitating with inability to work or to perform normal daily activity.
Time Frame
From Baseline to week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Willing and able to sign informed consent from and comply with visit and study procedures per protocol.
Male or female patients≥50 yrs. of age.
Active subfoveal or parafoveal CNV secondary to neovascular AMD on FFA or OCT.
The CNV area≥50% lesion area on FFA in the study eye at screening visit.
BCVA score of 24-78 letters using ETDRS charts in the study eye at the baseline.
Exclusion Criteria:
Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results.
Subretinal hemorrhage>50% total lesion area and/or involvement in the macular foveal, fibrosis or atrophy area>50% total lesion area and/or involved of macular fovea;
Presence of uncontrolled glaucoma in the study eye(defined as IOP≥25mmHg, or judged by the investigators at the screening or baseline visit)
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 within 3 months prior to screening;
Laser photocoagulation within 3 months prior to screening;
Photodynamic therapy or vitreoretinal surgery;
Intraocular glucocorticoid injection within 6 months prior to enrollment;
Presence of any systemic disease: including but not limited tractive infections (such as active viral hepatitis); unstable angina; cerebrovascular accident or transient cerebral ischemia (within 6 months prior to selection); myocardial infarction (within 6 months prior to selection); serious arrhythmia requiring medical treatment; liver, kidney or metabolic diseases; 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 three months prior to enrollment, or attempted to participate in other drug trials during the study;
Other conditions unsuitable for enrollment judged by investigators
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yating Liu
Phone
86 15821084695
Email
yating.liu@innoventbio.com
12. IPD Sharing Statement
Learn more about this trial
A Study of Longer Interval of IVT IBI302 in Subjects With nAMD
We'll reach out to this number within 24 hrs