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

Phase 1

Active, not recruiting

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Biological: IBI333

• Registration Number: NCT05639530
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-14
• Study First Submitted QC: 2022-11-28
• Study First Posted: 2022-12-06
• Study Start: 2023-02-27
• Primary Completion: 2023-12-07
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-26
• Study Completion: 2024-04-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
:treated with different doses of single intravitreal injections of IBI333	IBI333	Biological: IBI333 Dose 1 IBI333 of single IVT injections， Biological: IBI333 Dose 2 IBI333 of single IVT injections
treated with different doses of multiple intravitreal injections of IBI333	IBI333	Biological: IBI333 Dose 3 IBI333 of multiple IVT injections， Biological: IBI333 Dose 4 IBI333 of multiple IVT injections

Primary Outcome Measures

Name	Time	Method
Safety and tolerance indicators	Through study completion, a maximum of 24 weeks	1. Incidence, relatedness and severity of all adverse events (AE), treatment emergent adverse events (TEAE) and serious adverse events (SAE); 2. Incidence of dose limiting toxicity;

Secondary Outcome Measures

Name	Time	Method
Maximum concentration (Cmax) of the drug after the administration.	Through study completion, a maximum of 24 weeks
Time at which maximum concentration (Tmax) occurs for the drug after the administration.	Through study completion, a maximum of 24 weeks
Number of participants with anti-drug antibodies or neutralizing antibodies .	Through study completion, a maximum of 24 weeks
Changes of CST measured by spectral domain optical coherence tomography (SD-OCT) from baseline.	Through study completion, a maximum of 24 weeks
The area under the curve (AUC) of serum concentration of the drug after the administration.	Through study completion, a maximum of 24 weeks
Changes of BCVA measured by ETDRS chart from baseline.	Through study completion, a maximum of 24 weeks
The half-life (t1/2) of drug after the administration .	Through study completion, a maximum of 24 weeks
Proportion of subjects without intraretinal or subretinal fluid on SD-OCT.	Through study completion, a maximum of 24 weeks
Change of height of pigment epithelial detachment from baseline on SD-OCT.	Through study completion, a maximum of 24 weeks

Trial Locations

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China