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

Innovent Biologics

Status and phase: Completed; Phase 2

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Drug: Aflibercept; Biological: dose 1 IBI302; Biological: dose 2 IBI302

Study type: Interventional

Funder types: Industry

Identifiers

NCT05403749

CIBI302A202

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 3 patient groups

IBI302 dose 2 group

Experimental group

Description:

Drug: Aflibercept 8mg/eye;Intraocular injection

Treatment:

Biological: dose 2 IBI302

Aflibercept

Active Comparator group

Description:

Drug: Aflibercept 2mg/eye;Intraocular injection

Treatment:

Drug: Aflibercept

IBI302 dose 1 group

Experimental group

Description:

Drug: Aflibercept 6.4mg/eye;Intraocular injection

Treatment:

Biological: dose 1 IBI302