A Study of IBI302 in Patients With nAMD

Innovent Biologics

Status and phase: Completed; Phase 2

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Biological: High dose IBI302; Drug: Aflibercept; Biological: Low dose IBI302

Study type: Interventional

Funder types: Industry

Identifiers

NCT04820452

CIBI302A201

Details and patient eligibility

About

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.

Enrollment: 231 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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231 participants in 3 patient groups

cohort 1 IBI302 treated with high dose level of IBI302

Experimental group

Description:

Drug: IBI302 4mg/eye;Intraocular injection

Treatment:

Biological: High dose IBI302

Aflibercept

Active Comparator group

Description:

Drug: Aflibercept 2mg/eye;Intraocular injection

Treatment:

Drug: Aflibercept

cohort 1 IBI302 treated with low dose level of IBI302

Experimental group

Description:

Drug: IBI302 2mg/eye;Intraocular injection

Treatment:

Biological: Low dose IBI302