A Dose Escalation Study of IBI333 in Subjects With Neovascular Age-related Macular Degeneration

NCT ID: NCT05639530

Last Updated: 2024-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-27
• Study Completion Date: 2024-04-23

Brief Summary

This study is designed for multi-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single and multiple intravitreal injection of IBI333 in subjects with neovascular age-related macular degeneration (nAMD).

Conditions

Neovascular Age-related Macular Degeneration

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

:treated with different doses of single intravitreal injections of IBI333

Biological: IBI333 Dose 1 IBI333 of single IVT injections，

Biological: IBI333 Dose 2 IBI333 of single IVT injections

Group Type: EXPERIMENTAL

IBI333

Intervention Type: BIOLOGICAL

Intravitreal injection of IBI333

treated with different doses of multiple intravitreal injections of IBI333

Biological: IBI333 Dose 3 IBI333 of multiple IVT injections，

Biological: IBI333 Dose 4 IBI333 of multiple IVT injections

Group Type: EXPERIMENTAL

IBI333

Intervention Type: BIOLOGICAL

Intravitreal injection of IBI333

Interventions

IBI333

Intravitreal injection of IBI333

Intervention Type: BIOLOGICAL

Eligibility 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 patients ≥ 50 yrs. of age.

3. Active CNV lesions secondary to neovascular AMD.

4. BCVA score of 19-78 letters using ETDRS charts in the study eye.

5. Female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 6 months after the end of treatment.

Exclusion Criteria

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

2. Tractional retinal detachment, pre-retinal fibrosis, vitreomacular traction, or epiretinal membrane involving the fovea or disrupting the macular structure in the study eye;

3. Active ocular or periocular inflammation/infection in either eye;

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

1. Anti-VEGF therapy within 90 days prior to screening;

2. Intraocular glucocorticoid injection within 180 days prior to screening;

3. Laser photocoagulation or photodynamic therapy within 90 days prior to screening;

4. Intraocular surgery within 90 days prior to screening;

5. Laser posterior capsulotomy, laser trabeculectomy or laser peripheral iridectomy within 30 days prior to screening;

5. Glycated hemoglobin (HbA1c) > 8% within 28 days prior to screening;

6. Uncontrolled hypertension (defined as systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg);

7. Systemic administration of steroids within 30 days prior to screening;

8. Systemic administration of anti-VEGF drugs within 90 days prior to screening;

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

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

11. Other conditions unsuitable for enrollment judged by investigators.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

CIBI333A101

Identifier Type: -

Identifier Source: org_study_id