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

Innovent Biologics

Status and phase: Completed; Phase 1

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Biological: IBI333

Study type: Interventional

Funder types: Industry

Identifiers

NCT05639530

CIBI333A101

Details and patient eligibility

About

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).

Enrollment: 17 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

17 participants in 2 patient groups

:treated with different doses of single intravitreal injections of IBI333

Experimental group

Description:

Biological: IBI333 Dose 1 IBI333 of single IVT injections， Biological: IBI333 Dose 2 IBI333 of single IVT injections

Treatment:

Biological: IBI333

treated with different doses of multiple intravitreal injections of IBI333

Experimental group

Description:

Biological: IBI333 Dose 3 IBI333 of multiple IVT injections， Biological: IBI333 Dose 4 IBI333 of multiple IVT injections

Treatment:

Biological: IBI333