Evaluation of IBI302 Injection in nAMD or DME

NCT ID: NCT05961007

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 234 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-18
• Study Completion Date: 2024-04-30

Brief Summary

The purpose of this study is to determine the efficacy and safety of intravitreal IBI302 in the treatment of subjects with neovascular age-related macular degeneration (only in Phase I) or diabetic macular edema.

Conditions

Neovascular Age-related Macular Degeneration; Diabetic Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Aflibercept

only phase II

Group Type: ACTIVE_COMPARATOR

Intravitreal injection of Aflibercept

Intervention Type: DRUG

Aflibercept intravitreal injection given as protocol

IBI302

Group Type: EXPERIMENTAL

Intravitreal injection of IBI302(dose 1)

Intervention Type: BIOLOGICAL

IBI302(dose 1) intravitreal injection given as protocol

Intravitreal injection of IBI302(dose 2)

Intervention Type: BIOLOGICAL

IBI302(dose 2) intravitreal injection given as protocol

Intravitreal injection of IBI302(dose 3)

Intervention Type: BIOLOGICAL

IBI302(dose 3) intravitreal injection given as protocol

Interventions

Intravitreal injection of IBI302(dose 1)

IBI302(dose 1) intravitreal injection given as protocol

Intervention Type: BIOLOGICAL

Intravitreal injection of IBI302(dose 2)

IBI302(dose 2) intravitreal injection given as protocol

Intervention Type: BIOLOGICAL

Intravitreal injection of IBI302(dose 3)

IBI302(dose 3) intravitreal injection given as protocol

Intervention Type: BIOLOGICAL

Intravitreal injection of Aflibercept

Aflibercept intravitreal injection given as protocol

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Willing and able to sign informed consent form and comply with visit and study procedures per protocol;

2. Male or female patiensubjects ≥ 18 yrs. of age;

3. For AMD subjects, active subfoveal or parafoveal CNV secondary to neovascular AMD; the vision decreased by nAMD;

4. For DME subjects, Type 1 or type 2 diabetes mellitus, decrease in vision determined to be primarily the result of DME in the study eye; the CST measurement of ≥ 280 μm in the study eye;

5. BCVA ETDRS letter score of 24-73 in the study eye;

Exclusion Criteria

1. Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results;

2. Presence of uncontrolled glaucoma in the study eye ;

3. Presence of active intraocular or periocular inflammation or infection;

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

1. Anti-VEGF therapy or anti-complement therapy;

2. Laser photocoagulation;

3. History of vitreoretinal surgery;

4. Glucocorticoid treatment(intravitreal or peribulbar) ;

5. BCVA score <19 letters in the fellow eye;

6. Anti-VEGF therapy in the fellow eye within 30 days of day 0;

7. Presence of any systemic disease: including but not limited to active infections (such as active viral hepatitis); unstable angina; cerebrovascular accident or transient cerebral ischemia (within 6 months prior to screening); myocardial infarction (within 6 months prior to screening; serious arrhythmia requiring medical treatment; liver, kidney or metabolic diseases; uncontrolled clinical disease(such as diabetes mellitus, hypertension) or malignant tumor;

8. History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;

9. Pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period;

10. Participated in any clinical study of any other drug within 90 days of day 0, or attempted to participate in other drug trials during the study;

11. Other conditions unsuitable for enrollment judged by investigatiors.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

CIBI302B201

Identifier Type: -

Identifier Source: org_study_id