A Study to Evaluate the Efficacy and Safety of IBI302 in Subjects with NAMD

Innovent Biologics

Status and phase: Active, not recruiting; Phase 3

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Biological: IBI302; Drug: Aflibercept Ophthalmic

Study type: Interventional

Funder types: Industry

Identifiers

NCT05972473

CIBI302A301CN

Details and patient eligibility

About

The study is designed for multi-center,randomized,double-masked,active-contralled study to evaluate effective and security of intravitreal injection of IBI302 in subjects with neovascular age-related macular degeneration.

Enrollment: 600 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent must be obtained prior to study participation;
2. Male or female ≥ 50 years of age at the time of signing the informed consent;
3. Active subfoveal CNV secondary to nAMD, or active CNV with intra/subretinal fluid involving the fovea;
4. BCVA of 19 to 78 ETDRS letters (inclusive) in the study eye at baseline.

Exclusion criteria

1. Ocular disease:

   • Any concurrent intraocular condition/systemic disease in the study eye at screening or baseline that, in the judgment of the investigator, may cause the participant fail to respond to the treatment or confuse the interpretation of study results;
   • Total lesion area(including blood, atrophy, fibrosis, PED and neovascularization)> 12 optic disc area (DA) on FFA;
   • Subretinal hemorrhage area > 50% of the total lesion area, or subretinal hemorrhage area involving macular fovea ≥ 1 DA;
   • Fibrosis or atrophy area > 50% of the total lesion area, or involving the fovea; Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg after standard treatment);
   • Presence of active intraocular or periocular infection or inflammation;

2. Ocular treatment:

   • Anti-VEGF or anti-complement therapy in the study eye within 90 days prior to baseline;
   • Fundus laser photo-coagulation in the study eye within 90 days prior to baseline;
   • Photodynamic Therapy (PDT) in the study eye within 90 days prior to baseline;
   • History of vitreoretinal surgery, penetrating keratoplasty in the study eye;

3. General condition or treatment:

   • Uncontrolled hypertension (defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg after standard treatment);
   • HbA1c > 8% within 28 days prior to baseline; Systemic anti-VEGF drug and anti-complement drug therapy within 90 days prior to baseline;
   • History of hypersensitivity to any component of the test article, control article, or clinically relevant sensitivity to fluorescein dye, povidone-iodine;
   • Pregnant or lactating women; Inappropriate for the study (e.g., substance abuse, inability or unwillingness to follow the trial protocol), as judged by the investig.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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600 participants in 2 patient groups

Aflibercept

Active Comparator group

Description:

Drug: Aflibercept 2mg/eye; Intraocular injection

Treatment:

Drug: Aflibercept Ophthalmic

IBI302 dose 8mg

Experimental group

Description:

Drug: IBI302 8mg/eye; Intraocular injection

Treatment:

Biological: IBI302