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

NCT05403749 | Completed Phase 2

• 1 other identifier: CIBI302A202
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change of BCVA from baseline

  Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.

  Baseline to week 40

Secondary Outcomes (7)

• Percentage of Participants Loss >0,≥5,10，15 Letters From the Baseline BCVA in the Study Eye Over Time

  Baseline to week 52

• Change of Central Subfield Thickness in the Study Eye from baseline

  Baseline to week 52

• Change of Total Area of Choroidal Neovascularization (CNV) Lesion/Total Area of Choroidal Neovascularization Leakage in the Study Eye from Baseline

  From Baseline to week 52

• Percentage of Participants in different dosage of IBI302 Arm on Once Every 8-Weeks, 12-Weeks,Treatment Intervals

  At Week 20,40,52

• Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants

  From Baseline to week 52

Study Arms (3)

IBI302 dose 2 group

EXPERIMENTAL

Drug: Aflibercept 8mg/eye;Intraocular injection

Biological: dose 2 IBI302

Aflibercept

ACTIVE COMPARATOR

Drug: Aflibercept 2mg/eye;Intraocular injection

Drug: Aflibercept

IBI302 dose 1 group

EXPERIMENTAL

Drug: Aflibercept 6.4mg/eye;Intraocular injection

Biological: dose 1 IBI302

Interventions

dose 1 IBI302 BIOLOGICAL

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

IBI302 dose 1 group

Aflibercept DRUG

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

Aflibercept

dose 2 IBI302 BIOLOGICAL

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

IBI302 dose 2 group

Eligibility Criteria

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

You may qualify if:

• Willing and able to sign informed consent from and comply with visit and study procedures per protocol.
• Male or female patients≥50 yrs. of age.
• Active subfoveal or parafoveal CNV secondary to neovascular AMD on FFA or OCT.
• The CNV area≥50% lesion area on FFA in the study eye at screening visit.
• BCVA score of 24-78 letters using ETDRS charts in the study eye at the baseline.

You may not qualify if:

• Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results.
• 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;
• Presence of uncontrolled glaucoma in the study eye(defined as IOP≥25mmHg, or judged by the investigators at the screening or baseline visit)
• Presence of active intraocular or periocular inflammation or infection;
• 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;
• 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;
• History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
• Pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period;
• 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;
• Other conditions unsuitable for enrollment judged by investigators

Sponsors & Collaborators

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

Study Sites (1)

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

MeSH Terms

Interventions

aflibercept

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: June 3, 2022
• Study Start: June 29, 2022
• Primary Completion: May 13, 2024
• Study Completion: May 13, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-06

Locations

CN (1)