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

A Multi-center, Randomized, Double-masked, Active-controlled Study to Evaluate the Longer Interval of Intravitreal (IVT) Injection of IBI302 in Subjects With Neovascular Age-related Macular Degeneration (nAMD)

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.

Study Overview

• Status: Completed
• Conditions: Neovascular Age-related Macular Degeneration
• Intervention / Treatment: Biological: dose 2 IBI302; Drug: Aflibercept; Biological: dose 1 IBI302

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200080
      • Shanghai First People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aflibercept; Drug: Aflibercept 2mg/eye;Intraocular injection	Drug: Aflibercept; Three consecutive monthly intravitreal injections of 2.0mg Aflibercept followed by injection every other month
Experimental: IBI302 dose 2 group; Drug: Aflibercept 8mg/eye;Intraocular injection	Biological: dose 2 IBI302; After 4 loading monthly intravitreal injections of dose 2 IBI302，the following IBI302 IVT is given as descript in protocol
Experimental: IBI302 dose 1 group; Drug: Aflibercept 6.4mg/eye;Intraocular injection	Biological: dose 1 IBI302; After 4 loading monthly intravitreal injections of dose 1 IBI302，the following IBI302 IVT is given as descript in protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Gaining ≥0,5,10,15 Letters From the Baseline BCVA in the Study Eye Over Time	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 letter score from baseline indicates an improvement in visual acuity.	From Baseline to week 52
Percentage of Participants Loss >0,≥5,10，15 Letters From the Baseline BCVA in the Study Eye Over Time	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 loss in BCVA letter score from baseline indicates a decline in visual acuity.	Baseline to week 52
Change of Central Subfield Thickness in the Study Eye from baseline	Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane using optical coherence tomography (OCT), as assessed by the central reading center.	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	This safety summary reports the number and percentage of participants who experienced at least one adverse event (AE) during the study. AEs are categorized as any AEs, ocular AEs occurring in the study eye or fellow eye, systemic AEs, serious AEs, AEs related to treatment with study drug, AEs of special interest. The investigator independently assessed the seriousness and severity for each AE. Severity was graded according to the following grading scale: Mild = Discomfort noticed, but no disruption of normal daily activity; Moderate = Discomfort sufficient to reduce or affect normal daily activity; Severe = Incapacitating with inability to work or to perform normal daily activity.	From 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	The total area of the choroidal neovascularization lesion/Total Area of Choroidal Neovascularization Leakage in the study eye was evaluated by a central reading center using fundus fluorescein angiography (FFA).	From Baseline to week 52
Immunogenicity end points	Production of anti-drug antibodies in serum.	From Baseline to week 52

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2022
• Primary Completion (Actual): May 13, 2024
• Study Completion (Actual): May 13, 2024

Study Registration Dates

• First Submitted: May 20, 2022
• First Submitted That Met QC Criteria: May 26, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Wet Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: CIBI302A202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No