A Study of Longer Interval of IVT IBI302 in Subjects With nAMD

NCT ID: NCT05403749

Last Updated: 2024-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-29
• Study Completion Date: 2024-05-13

Brief Summary

The study is designed for multi-center, randomized, double-masked, active-controlled study to evaluate the longer interval of intravitreal injection 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: DOUBLE

Study Groups

IBI302 dose 2 group

Drug: Aflibercept 8mg/eye;Intraocular injection

Group Type: EXPERIMENTAL

dose 2 IBI302

Intervention Type: BIOLOGICAL

After 4 loading monthly intravitreal injections of dose 2 IBI302，the following IBI302 IVT is given as descript in protocol

Aflibercept

Drug: Aflibercept 2mg/eye;Intraocular injection

Group Type: ACTIVE_COMPARATOR

Aflibercept

Intervention Type: DRUG

Three consecutive monthly intravitreal injections of 2.0mg Aflibercept followed by injection every other month

IBI302 dose 1 group

Drug: Aflibercept 6.4mg/eye;Intraocular injection

Group Type: EXPERIMENTAL

dose 1 IBI302

Intervention Type: BIOLOGICAL

After 4 loading monthly intravitreal injections of dose 1 IBI302，the following IBI302 IVT is given as descript in protocol.

Interventions

dose 1 IBI302

After 4 loading monthly intravitreal injections of dose 1 IBI302，the following IBI302 IVT is given as descript in protocol.

Intervention Type: BIOLOGICAL

Aflibercept

Three consecutive monthly intravitreal injections of 2.0mg Aflibercept followed by injection every other month

Intervention Type: DRUG

dose 2 IBI302

After 4 loading monthly intravitreal injections of dose 2 IBI302，the following IBI302 IVT is given as descript in protocol

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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

2. Male or female patients≥50 yrs. of age.

3. Active subfoveal or parafoveal CNV secondary to neovascular AMD on FFA or OCT.

4. The CNV area≥50% lesion area on FFA in the study eye at screening visit.

5. BCVA score of 24-78 letters using ETDRS charts in the study eye at the baseline.

Exclusion Criteria

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

2. Subretinal hemorrhage>50% total lesion area and/or involvement in the macular foveal, fibrosis or atrophy area>50% total lesion area and/or involved of macular fovea;

3. Presence of uncontrolled glaucoma in the study eye(defined as IOP≥25mmHg, or judged by the investigators at the screening or baseline visit)

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

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

• Anti-VEGF(Vascular Endothelial Growth Factor) therapy or anti-complement therapy within 3 months prior to screening;
• Laser photocoagulation within 3 months prior to screening;
• Photodynamic therapy or vitreoretinal surgery;
• Intraocular glucocorticoid injection within 6 months prior to enrollment;

6. Presence of any systemic disease: including but not limited tractive 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;

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

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

9. 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;

10. 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

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

CIBI302A202

Identifier Type: -

Identifier Source: org_study_id