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Study of IBI333 in Subjects With Neovascular Age-related Macular Degeneration

Primary Purpose

Neovascular Age-related Macular Degeneration

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
IBI333
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: Willing and able to sign informed consent form and comply with visit and study procedures per protocol. Male or female patients ≥ 50 yrs. of age. Active CNV lesions secondary to neovascular AMD. BCVA score of 19-78 letters using ETDRS charts in the study eye. Female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 6 months after the end of treatment. Exclusion Criteria: Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results; Tractional retinal detachment, pre-retinal fibrosis, vitreomacular traction, or epiretinal membrane involving the fovea or disrupting the macular structure in the study eye; Active ocular or periocular inflammation/infection in either eye; Prior any treatment of following in the study eye: Anti-VEGF therapy within 90 days prior to screening; Intraocular glucocorticoid injection within 180 days prior to screening; Laser photocoagulation or photodynamic therapy within 90 days prior to screening; Intraocular surgery within 90 days prior to screening; Laser posterior capsulotomy, laser trabeculectomy or laser peripheral iridectomy within 30 days prior to screening; Glycated hemoglobin (HbA1c) > 8% within 28 days prior to screening; Uncontrolled hypertension (defined as systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg); Systemic administration of steroids within 30 days prior to screening; Systemic administration of anti-VEGF drugs within 90 days prior to screening; History of severe hypersensitivity/allergic to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine; Participated in any clinical study of any other drug within 90 days prior to enrollment, or attempted to participate in other drug trials during the study; Other conditions unsuitable for enrollment judged by investigators.

Sites / Locations

  • Peking Union Medical College Hospital, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

:treated with different doses of single intravitreal injections of IBI333

treated with different doses of multiple intravitreal injections of IBI333

Arm Description

Biological: IBI333 Dose 1 IBI333 of single IVT injections, Biological: IBI333 Dose 2 IBI333 of single IVT injections

Biological: IBI333 Dose 3 IBI333 of multiple IVT injections, Biological: IBI333 Dose 4 IBI333 of multiple IVT injections

Outcomes

Primary Outcome Measures

Safety and tolerance indicators
Incidence, relatedness and severity of all adverse events (AE), treatment emergent adverse events (TEAE) and serious adverse events (SAE); Incidence of dose limiting toxicity;

Secondary Outcome Measures

The area under the curve (AUC) of serum concentration of the drug after the administration.
Maximum concentration (Cmax) of the drug after the administration.
Time at which maximum concentration (Tmax) occurs for the drug after the administration.
The half-life (t1/2) of drug after the administration .
Number of participants with anti-drug antibodies or neutralizing antibodies .
Changes of BCVA measured by ETDRS chart from baseline.
Changes of CST measured by spectral domain optical coherence tomography (SD-OCT) from baseline.
Proportion of subjects without intraretinal or subretinal fluid on SD-OCT.
Change of height of pigment epithelial detachment from baseline on SD-OCT.

Full Information

First Posted
November 14, 2022
Last Updated
March 9, 2023
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05639530
Brief Title
Study of IBI333 in Subjects With Neovascular Age-related Macular Degeneration
Official Title
A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of IBI333 in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2022 (Actual)
Primary Completion Date
October 13, 2023 (Anticipated)
Study Completion Date
January 7, 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
This study is designed for multi-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single and multiple intravitreal injection of IBI333 in subjects with neovascular age-related macular degeneration (nAMD).

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
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
:treated with different doses of single intravitreal injections of IBI333
Arm Type
Experimental
Arm Description
Biological: IBI333 Dose 1 IBI333 of single IVT injections, Biological: IBI333 Dose 2 IBI333 of single IVT injections
Arm Title
treated with different doses of multiple intravitreal injections of IBI333
Arm Type
Experimental
Arm Description
Biological: IBI333 Dose 3 IBI333 of multiple IVT injections, Biological: IBI333 Dose 4 IBI333 of multiple IVT injections
Intervention Type
Biological
Intervention Name(s)
IBI333
Intervention Description
Intravitreal injection of IBI333
Primary Outcome Measure Information:
Title
Safety and tolerance indicators
Description
Incidence, relatedness and severity of all adverse events (AE), treatment emergent adverse events (TEAE) and serious adverse events (SAE); Incidence of dose limiting toxicity;
Time Frame
Through study completion, a maximum of 24 weeks
Secondary Outcome Measure Information:
Title
The area under the curve (AUC) of serum concentration of the drug after the administration.
Time Frame
Through study completion, a maximum of 24 weeks
Title
Maximum concentration (Cmax) of the drug after the administration.
Time Frame
Through study completion, a maximum of 24 weeks
Title
Time at which maximum concentration (Tmax) occurs for the drug after the administration.
Time Frame
Through study completion, a maximum of 24 weeks
Title
The half-life (t1/2) of drug after the administration .
Time Frame
Through study completion, a maximum of 24 weeks
Title
Number of participants with anti-drug antibodies or neutralizing antibodies .
Time Frame
Through study completion, a maximum of 24 weeks
Title
Changes of BCVA measured by ETDRS chart from baseline.
Time Frame
Through study completion, a maximum of 24 weeks
Title
Changes of CST measured by spectral domain optical coherence tomography (SD-OCT) from baseline.
Time Frame
Through study completion, a maximum of 24 weeks
Title
Proportion of subjects without intraretinal or subretinal fluid on SD-OCT.
Time Frame
Through study completion, a maximum of 24 weeks
Title
Change of height of pigment epithelial detachment from baseline on SD-OCT.
Time Frame
Through study completion, a maximum of 24 weeks

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 form and comply with visit and study procedures per protocol. Male or female patients ≥ 50 yrs. of age. Active CNV lesions secondary to neovascular AMD. BCVA score of 19-78 letters using ETDRS charts in the study eye. Female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 6 months after the end of treatment. Exclusion Criteria: Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results; Tractional retinal detachment, pre-retinal fibrosis, vitreomacular traction, or epiretinal membrane involving the fovea or disrupting the macular structure in the study eye; Active ocular or periocular inflammation/infection in either eye; Prior any treatment of following in the study eye: Anti-VEGF therapy within 90 days prior to screening; Intraocular glucocorticoid injection within 180 days prior to screening; Laser photocoagulation or photodynamic therapy within 90 days prior to screening; Intraocular surgery within 90 days prior to screening; Laser posterior capsulotomy, laser trabeculectomy or laser peripheral iridectomy within 30 days prior to screening; Glycated hemoglobin (HbA1c) > 8% within 28 days prior to screening; Uncontrolled hypertension (defined as systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg); Systemic administration of steroids within 30 days prior to screening; Systemic administration of anti-VEGF drugs within 90 days prior to screening; History of severe hypersensitivity/allergic to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine; Participated in any clinical study of any other drug within 90 days 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
Youxin Chen, MD
Phone
+8613801025972
Email
chenyouxinpumch@163.com
Facility Information:
Facility Name
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101199
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanyuan Sun
Phone
010-87705665
Email
sunyanyuan@pumch.cn
First Name & Middle Initial & Last Name & Degree
Hong Dai, MD
First Name & Middle Initial & Last Name & Degree
Lijun Shen, MD
First Name & Middle Initial & Last Name & Degree
Wu Liu, MD
First Name & Middle Initial & Last Name & Degree
Liming Tao, MD
First Name & Middle Initial & Last Name & Degree
Xiaorong Li, MD
First Name & Middle Initial & Last Name & Degree
Laichun Lu, MD
First Name & Middle Initial & Last Name & Degree
Xiaodon Sun, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of IBI333 in Subjects With Neovascular Age-related Macular Degeneration

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