A Study of IBI302 in Patients With nAMD

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

A Multi-center, Randomized, Double-blind, Active-controlled Phase II Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With Neovascular Age-related Macular Degeneration

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04820452
• Other study ID #: CIBI302A201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 28, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: September 2022
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-center, randomized, double-blind, active-controlled study to evaluate the efficacy and safety of IBI302 in subjects with neovascular age-related macular degeneration.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 231
• Est. completion date: May 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion criteria

1. Male or female patient = 50 yrs. of age.

2. Active subfoveal or parafoveal CNV secondary to neovascular AMD.

3. BCVA score of 24-73 letters using ETDRS charts in the study eye.

4. Willing and able to sign informed consent form and comply with visit and study procedures per protocol.

Exclusion criteria

1. Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results;

2. Presence of uncontrolled glaucoma in the study eye (defined as IOP=25mmHg despite the standardized treatment);

3. Presence of active intraocular or periocular inflammation or infection;

4. Prior any treatment of following in the study eye:

1. Anti-VEGF therapy or anti-complement therapy within 3 months prior to screening;

2. Laser photocoagulation within 3 months prior to screening;

3. Photodynamic therapy or vitreoretinal surgery;

4. Intraocular glucocorticoid injection within 6 months prior to enrollment;

5. Presence of any systemic disease: including but not limited toactive 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;

6. History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;

7. Pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period;

8. 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;

9. Other conditions unsuitable for enrollment judged by investigators

Related Conditions & MeSH terms

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

Intervention

Biological:
• Low dose IBI302
Low dose IBI302 intravitreal injection given as every other month after three loading monthly injection
• High dose IBI302
High dose IBI302 intravitreal injection given as every other month after three loading monthly injection

Drug:
• Aflibercept
Intraocular injection

Locations

Country	Name	City	State
China	Innovent Biologics (Suzhou) Co,Ltd.	Suzhou	Jiangsu

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	The visual efficacy of IBI302		Baseline to week 36
Secondary	other visual effects of IBI302	the proportion if BCVA improvement =0,5,10 or 15 letters at week 12, 28, 36 and 52.	Baseline to week 52
Secondary	the anatomical effects of IBI302 on OCT	the mean change of central subfield thickness from BL to week 52 at week 12, 28, 36 and 52	Baseline to week 52
Secondary	the anatomical effects of IBI302 on FFA	the change of CNV area, CNV leakage area, total lesion area from BL to week 36 or 52	Baseline to week 52
Secondary	the safety of IBI302	the incidence of ocular AE or any systemic AE, TEAE, SAE	Baseline to week 52
Secondary	Immunogenicity of IBI302	the positive rate of anti-drug antibody and neutralizing antibody	Baseline to week 52