A Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With nAMD

NCT05972473 | Active Not Recruiting Phase 3

• 1 other identifier: CIBI302A301CN
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in Best corrected visual acuity ( BCVA ) in the study eye.

  Change from Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score at week 44, 48, 52.

  At week 44, 48, 52

Secondary Outcomes (6)

• The proportion of participants with absence intraretinal fluid (IRF) and absence subretinal fluid (SRF) in the fovea at Week 16

  At week 16

• Change from baseline in BCVA at Week 52 and 100

  Upto Week 100

• Change from baseline in central subfield thickness (CST) measured by optical coherence tomography (OCT) at Week 52 and 100

  Upto Week 100

• Change from baseline in area of CNV on fundus fluorescence angiography (FFA) at Week 52 and 100

  Upto Week 100

• Proportion of participants on a q8W, q12W, and q16W treatment intervals at Week 52 and 100

  Upto Week 100

Study Arms (2)

Aflibercept

ACTIVE COMPARATOR

Drug: Aflibercept 2mg/eye; Intraocular injection

Drug: Aflibercept Ophthalmic

IBI302 dose 8mg

EXPERIMENTAL

Drug: IBI302 8mg/eye; Intraocular injection

Biological: IBI302

Interventions

Aflibercept Ophthalmic DRUG

2mg Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive monthes, folloesd by once every 8 weeks(Q8W).

Aflibercept

IBI302 BIOLOGICAL

8 mg IBI302 will be administered by intraitreal injection into the study eye at intervals as specified in the study protocol.

IBI302 dose 8mg

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;
• 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;
• 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;

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

MeSH Terms

Interventions

IBI302

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 2, 2023
• Study Start: September 21, 2023
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)