Back to resultsA Dose Escalation Study of IBI302 in Patients With Wet Age-related Macular Degeneration
Primary Purpose
Neovascular Age-related Macular Degeneration
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
IBI302
IBI302
IBI302
IBI302
IBI302
IBI302
Sponsored by
About this trial
This is an interventional treatment trial for Neovascular Age-related Macular Degeneration
Eligibility Criteria
Inclusion Criteria:
- Male or female patient ≥ 50 yrs. of age.
- Active subfoveal CNV secondary to wet AMD, with lesion size ≤ 12 optic discs in the study eye.
- BCVA score of 10-73 letters using ETDRS charts (in 4 meters) in the study eye.
- Central macular sub-field thickness according to OCT of at least 250 micron.
- Clear stereoscopic fundus photography is obtained while the lens or other media is clear.
- Female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 3 months after the end of treatment.
- Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
Exclusion Criteria:
- Presence of other causes of CNV other than wet AMD in the study eye.
- Presence of active diabetic retinopathy in the study eye.
- Presence of uncontrolled glaucoma in the study eye (defined as IOP≥30mmHg despite the standardized treatment).
- Prior retinal detachment in the study eye.
Prior any treatment of following in the study eye:
- Anti-VEGF therapy within 6 months prior to screening;
- Anti-complement therapy;
- Laser photocoagulation;
- Photodynamic therapy;
- Transpupillary thermotherapy
- Intraocular surgery;
- Intraocular or periocular glucocorticoid injection therapy within 6 months prior to enrollment;
- Presence of any non-AMD disease that may affect visual acuity in the study eye
- Prior anti-VEGF therapy within 1 month before study drug administration or plan of above anti-VEGF therapy in the non-study eye during the whole study.
- Oral steroid drugs within 1 month before study drug administration.
- Presence of active intraocular or periocular inflammation or infection.
Diabetic patients have any of the following conditions:
- Microvascular and macrovascular complications;
- HbA1c>7.5% when screening;
- Receiving more than two oral hypoglycemic agents;
- Receiving insulin or GLP-1 receptor agonist;
- Hypertension (defined as systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg despite standard treatment);
Presence of any following laboratory abnormality:
- PLT<100×109/L, INR≥1.5ULN, APTT≥ 10 seconds more than ULN;
- ALT or AST >2ULN;
- Cr or Ur>1.5ULN;
- Large or medium surgery, or unhealed surgical incisions, ulcers or fractures within 1 month before study drug administration.
Sites / Locations
- Shanghai General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
cohort 1 IBI302 treated with first dose level of IBI302
cohort 2 IBI302 treated with second dose level of IBI302
cohort 3 IBI302 treated with third dose level of IBI302
cohort 4 IBI302 treated with fourth dose level of IBI302
cohort 5 IBI302 treated with fifth dose level of IBI302
cohort 6 IBI302 treated with sixth dose level of IBI302
Arm Description
Outcomes
Primary Outcome Measures
Safety evaluation indicators
Decreasing of BCVA; b) Changes in intraocular pressure compared with baseline; c) Incidence, relatedness and severity of all adverse events, treatment emergent adverse events and serious adverse events;
Secondary Outcome Measures
Efficacy evaluation indicators
Changes in central subfield thickness by OCT compared with baseline; b) Changes in CNV area by FA compared with baseline; c) Changes in BCVA compared with baseline.
Immunogenicity evaluation indicators
Positive rate of anti-drug antibody and neutralizing antibody
The area under the drug-time curve from 0 to time t (AUC0-t)
The area under the curve at the time of 0-infinity (AUC0-∞)
The peak concentration (Cmax)
The peak time (Tmax)
Clearance rate (CL)
Half-life (t1/2)
Free and total VEGF concentration
Full Information
NCT ID
NCT03814291
First Posted
January 15, 2019
Last Updated
February 10, 2020
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03814291
Brief Title
A Dose Escalation Study of IBI302 in Patients With Wet Age-related Macular Degeneration
Official Title
A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of IBI302 in Patients With Wet Age-related Macular Degeneration (AMD)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 16, 2019 (Actual)
Primary Completion Date
February 21, 2020 (Anticipated)
Study Completion Date
April 5, 2020 (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
5. Study Description
Brief Summary
This study is designed for single-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single intravitreal injection of IBI302 in patients with wet AMD.
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 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cohort 1 IBI302 treated with first dose level of IBI302
Arm Type
Experimental
Arm Title
cohort 2 IBI302 treated with second dose level of IBI302
Arm Type
Experimental
Arm Title
cohort 3 IBI302 treated with third dose level of IBI302
Arm Type
Experimental
Arm Title
cohort 4 IBI302 treated with fourth dose level of IBI302
Arm Type
Experimental
Arm Title
cohort 5 IBI302 treated with fifth dose level of IBI302
Arm Type
Experimental
Arm Title
cohort 6 IBI302 treated with sixth dose level of IBI302
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
IBI302
Intervention Description
0.05mg/eye;Intraocular injection
Intervention Type
Drug
Intervention Name(s)
IBI302
Intervention Description
0.15mg/eye;Intraocular injection
Intervention Type
Drug
Intervention Name(s)
IBI302
Intervention Description
0.5mg/eye;Intraocular injection
Intervention Type
Drug
Intervention Name(s)
IBI302
Intervention Description
1mg/eye;Intraocular injection
Intervention Type
Drug
Intervention Name(s)
IBI302
Intervention Description
2mg/eye;Intraocular injection
Intervention Type
Drug
Intervention Name(s)
IBI302
Intervention Description
4mg/eye;Intraocular injection
Primary Outcome Measure Information:
Title
Safety evaluation indicators
Description
Decreasing of BCVA; b) Changes in intraocular pressure compared with baseline; c) Incidence, relatedness and severity of all adverse events, treatment emergent adverse events and serious adverse events;
Time Frame
Baseline to Day43
Secondary Outcome Measure Information:
Title
Efficacy evaluation indicators
Description
Changes in central subfield thickness by OCT compared with baseline; b) Changes in CNV area by FA compared with baseline; c) Changes in BCVA compared with baseline.
Time Frame
Baseline to Day43
Title
Immunogenicity evaluation indicators
Description
Positive rate of anti-drug antibody and neutralizing antibody
Time Frame
Baseline to Day43
Title
The area under the drug-time curve from 0 to time t (AUC0-t)
Time Frame
Baseline to Day43
Title
The area under the curve at the time of 0-infinity (AUC0-∞)
Time Frame
Baseline to Day43
Title
The peak concentration (Cmax)
Time Frame
Baseline to Day43
Title
The peak time (Tmax)
Time Frame
Baseline to Day43
Title
Clearance rate (CL)
Time Frame
Baseline to Day43
Title
Half-life (t1/2)
Time Frame
Baseline to Day43
Title
Free and total VEGF concentration
Time Frame
Baseline to Day43
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patient ≥ 50 yrs. of age.
Active subfoveal CNV secondary to wet AMD, with lesion size ≤ 12 optic discs in the study eye.
BCVA score of 10-73 letters using ETDRS charts (in 4 meters) in the study eye.
Central macular sub-field thickness according to OCT of at least 250 micron.
Clear stereoscopic fundus photography is obtained while the lens or other media is clear.
Female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 3 months after the end of treatment.
Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
Exclusion Criteria:
Presence of other causes of CNV other than wet AMD in the study eye.
Presence of active diabetic retinopathy in the study eye.
Presence of uncontrolled glaucoma in the study eye (defined as IOP≥30mmHg despite the standardized treatment).
Prior retinal detachment in the study eye.
Prior any treatment of following in the study eye:
Anti-VEGF therapy within 6 months prior to screening;
Anti-complement therapy;
Laser photocoagulation;
Photodynamic therapy;
Transpupillary thermotherapy
Intraocular surgery;
Intraocular or periocular glucocorticoid injection therapy within 6 months prior to enrollment;
Presence of any non-AMD disease that may affect visual acuity in the study eye
Prior anti-VEGF therapy within 1 month before study drug administration or plan of above anti-VEGF therapy in the non-study eye during the whole study.
Oral steroid drugs within 1 month before study drug administration.
Presence of active intraocular or periocular inflammation or infection.
Diabetic patients have any of the following conditions:
Microvascular and macrovascular complications;
HbA1c>7.5% when screening;
Receiving more than two oral hypoglycemic agents;
Receiving insulin or GLP-1 receptor agonist;
Hypertension (defined as systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg despite standard treatment);
Presence of any following laboratory abnormality:
PLT<100×109/L, INR≥1.5ULN, APTT≥ 10 seconds more than ULN;
ALT or AST >2ULN;
Cr or Ur>1.5ULN;
Large or medium surgery, or unhealed surgical incisions, ulcers or fractures within 1 month before study drug administration.
Facility Information:
Facility Name
Shanghai General Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
35648811
Citation
Yang S, Li T, Jia H, Gao M, Li Y, Wan X, Huang Z, Li M, Zhai Y, Li X, Yang X, Wang T, Liang J, Gu Q, Luo X, Qian L, Lu S, Liu J, Song Y, Wang F, Sun X, Yu D. Targeting C3b/C4b and VEGF with a bispecific fusion protein optimized for neovascular age-related macular degeneration therapy. Sci Transl Med. 2022 Jun;14(647):eabj2177. doi: 10.1126/scitranslmed.abj2177. Epub 2022 Jun 1.
Results Reference
derived
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A Dose Escalation Study of IBI302 in Patients With Wet Age-related Macular Degeneration
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