A Study of IBI302 in Patients With nAMD

NCT ID: NCT04820452

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 231 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-28
• Study Completion Date: 2023-01-13

Brief Summary

This is a multi-center, randomized, double-blind, active-controlled study to evaluate the efficacy and safety of IBI302 in subjects with neovascular age-related macular degeneration.

Conditions

Neovascular Age-related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

cohort 1 IBI302 treated with high dose level of IBI302

Drug: IBI302 4mg/eye;Intraocular injection

Group Type: EXPERIMENTAL

High dose IBI302

Intervention Type: BIOLOGICAL

High dose IBI302 intravitreal injection given as every other month after three loading monthly injection

Aflibercept

Drug: Aflibercept 2mg/eye;Intraocular injection

Group Type: ACTIVE_COMPARATOR

Aflibercept

Intervention Type: DRUG

Intraocular injection

cohort 1 IBI302 treated with low dose level of IBI302

Drug: IBI302 2mg/eye;Intraocular injection

Group Type: EXPERIMENTAL

Low dose IBI302

Intervention Type: BIOLOGICAL

Low dose IBI302 intravitreal injection given as every other month after three loading monthly injection

Interventions

Low dose IBI302

Low dose IBI302 intravitreal injection given as every other month after three loading monthly injection

Intervention Type: BIOLOGICAL

High dose IBI302

High dose IBI302 intravitreal injection given as every other month after three loading monthly injection

Intervention Type: BIOLOGICAL

Aflibercept

Intraocular injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female patient ≥ 50 yrs. of age.

2. Active subfoveal or parafoveal CNV secondary to neovascular AMD.

3. BCVA score of 24-73 letters using ETDRS charts in the study eye.

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

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 (defined as IOP≥25mmHg despite the standardized treatment);

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 within 3 months prior to screening;

2. Laser photocoagulation within 3 months prior to screening;

3. Photodynamic therapy or vitreoretinal surgery;

4. Intraocular glucocorticoid injection within 6 months prior to enrollment;

5. Presence of any systemic disease: including but not limited toactive 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;

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

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

8. 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;

9. Other conditions unsuitable for enrollment judged by investigators

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Innovent Biologics (Suzhou) Co,Ltd.

Suzhou, Jiangsu, China

Countries

China

Other Identifiers

CIBI302A201

Identifier Type: -

Identifier Source: org_study_id