A Dose Escalation Study of IBI324 in Subjects With Diabetic Macular Edema

October 25, 2023 updated by: Innovent Biologics (Suzhou) Co. Ltd.

A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of IBI324 in Subjects With Diabetic Macular Edema(DME)

This study is designed as a Multi-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single and multiple intravitreal injections of IBI324 in subjects with DME

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Xiaodong Xiaodong, MD, Ph. D
  • Phone Number: 021-63067385
  • Email: xdsun@sjtu.edu.cn

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200080
        • Shanghai General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
  2. Male or female subjects with age of 18~80 yrs.
  3. Diagnosis of diabetes mellitus(type 1 or 2), and current regular use of insulin or other injectable drugs or oral anti-hyperglycaemic agent for the treatment of diabetes.
  4. Visual impairment was caused by DME involving the macular fovea.
  5. Central macular sub-field thickness (CST) ≥320μm according to OCT.
  6. BCVA score of 24-73 letters using ETDRS charts (in 4 meters) in the study eye.
  7. 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.

Exclusion Criteria:

  1. Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results.
  2. PDR in the study eye.
  3. Tractional retinal detachment, pre-retinal fibrosis, vitreomacular traction, or epiretinal membrane involving the fovea or disrupting the macular architecture in the study eye.
  4. Active rubeosis in the study eye.
  5. The equivalent spherical lens≤-8.00D in the study eye.
  6. The intraocular pressure>21 mmHg in the study eye.
  7. Active ocular or periocular inflammation/infection in either eye.

  8. Prior any treatment of following in the study eye:

    • Intravitreal anti-VEGF treatment within 3 months prior to baseline;
    • Intraocular glucocorticoid injection within 3 months prior to baseline;
    • PRP, local/grid laser photocoagulation within 3 months prior to baseline;
    • Any intraocular surgery (e.g. cataract surgery) within 90 days prior to baseline;
    • The eyes were treated with lasik posterior capsulotomy or glaucoma filtration, radiotherapy 30 days before baseline;
  9. Currently untreated diabetes mellitus or previously untreated DM subjects who initiated oral or injectable antidiabetic medication or insulin <90 days;
  10. HbA1c of >10% within 28 days prior to baseline;
  11. Presence of any systemic disease: including but not limited to 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;
  12. History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
  13. Pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period;
  14. 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;
  15. Other conditions unsuitable for enrollment judged by investigators

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: treated with different doses of single intravitreal inmection of IBI324
Biological: IBI324
Dose 2 IBI324 of multiple IVT injection
Biological: IBI324
Dose 2 IBI324 of single IVT injection
Biological: IBI324
Dose 1 IBI324 of single IVT injection
Biological: IBI324
Dose 3 IBI324 of single IVT injection
Biological: IBI324
Dose 3 IBI324 of multiple IVT injection
Experimental: treated with different doses of multiple intravitreal inmection of IBI324
Biological: IBI324
Dose 2 IBI324 of multiple IVT injection
Biological: IBI324
Dose 2 IBI324 of single IVT injection
Biological: IBI324
Dose 1 IBI324 of single IVT injection
Biological: IBI324
Dose 3 IBI324 of single IVT injection
Biological: IBI324
Dose 3 IBI324 of multiple IVT injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety evaluation indicators
Time Frame: Through study completion, a maximum of 24 weeks
Incidence, relatedness and severity of all adverse events, treatment emergent adverse events and serious adverse events b) Changes in central subfield thickness by OCT compared with baseline
Through study completion, a maximum of 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The incidence of adverse events
Time Frame: Through study completion, a maximum of 24 weeks
Through study completion, a maximum of 24 weeks
Immunogenicity evaluation indicators
Time Frame: Through study completion, a maximum of 24 weeks
Positive rate of anti-drug antibody
Through study completion, a maximum of 24 weeks
Changes in visual acuity as measured by BCVA compared with baseline
Time Frame: Through study completion, a maximum of 24 week
Through study completion, a maximum of 24 week
Changes in the average thickness of the macula in the central 1 mm ETDRS grid (CST) compared with baseline
Time Frame: Through study completion, a maximum of 24 week
Through study completion, a maximum of 24 week
Pharmacokinetic (PK) profiles, such as half-life time (t1/2)，etc
Time Frame: Through study completion, a maximum of 24 weeks
Positive rate of anti-drug antibody
Through study completion, a maximum of 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 5, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 5, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIBI324A101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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