Evaluation of IBI302 Injection in nAMD or DME

Innovent Biologics

Status and phase: Suspended; Phase 2; Phase 1

Conditions: Diabetic Macular Edema; Neovascular Age-related Macular Degeneration

Treatments: Biological: Intravitreal injection of IBI302(dose 1); Drug: Intravitreal injection of Aflibercept; Biological: Intravitreal injection of IBI302(dose 3); Biological: Intravitreal injection of IBI302(dose 2)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05961007

CIBI302B201

Details and patient eligibility

About

The purpose of this study is to determine the efficacy and safety of intravitreal IBI302 in the treatment of subjects with neovascular age-related macular degeneration (only in Phase I) or diabetic macular edema.

Enrollment: 234 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Willing and able to sign informed consent form and comply with visit and study procedures per protocol;
2. Male or female patiensubjects ≥ 18 yrs. of age;
3. For AMD subjects, active subfoveal or parafoveal CNV secondary to neovascular AMD; the vision decreased by nAMD;
4. For DME subjects, Type 1 or type 2 diabetes mellitus, decrease in vision determined to be primarily the result of DME in the study eye; the CST measurement of ≥ 280 μm in the study eye;
5. BCVA ETDRS letter score of 24-73 in the study eye;

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 ;

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;
   2. Laser photocoagulation;
   3. History of vitreoretinal surgery;
   4. Glucocorticoid treatment(intravitreal or peribulbar) ;

5. BCVA score <19 letters in the fellow eye;

6. Anti-VEGF therapy in the fellow eye within 30 days of day 0;

7. Presence of any systemic disease: including but not limited to active infections (such as active viral hepatitis); unstable angina; cerebrovascular accident or transient cerebral ischemia (within 6 months prior to screening); myocardial infarction (within 6 months prior to screening; serious arrhythmia requiring medical treatment; liver, kidney or metabolic diseases; uncontrolled clinical disease(such as diabetes mellitus, hypertension) or malignant tumor;

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

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

10. Participated in any clinical study of any other drug within 90 days of day 0, or attempted to participate in other drug trials during the study;

11. Other conditions unsuitable for enrollment judged by investigatiors.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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234 participants in 2 patient groups

Aflibercept

Active Comparator group

Description:

only phase II

Treatment:

Drug: Intravitreal injection of Aflibercept

IBI302

Experimental group

Treatment:

Biological: Intravitreal injection of IBI302(dose 3)

Biological: Intravitreal injection of IBI302(dose 2)

Biological: Intravitreal injection of IBI302(dose 1)