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

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05403749
• Other study ID #: CIBI302A202
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 29, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: December 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 132
• Est. completion date: June 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

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

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

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

Locations

Country	Name	City	State
China	Shanghai First People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Percentage of Participants in different dosage of IBI302 Arm on Once Every 8-Weeks, 12-Weeks,Treatment Intervals		At Week 20,40,52
Secondary	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
Secondary	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
Secondary	Immunogenicity end points	Production of anti-drug antibodies in serum.	From Baseline to week 52