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

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of IBI333 in Subjects With Neovascular Age-related Macular Degeneration (nAMD)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05639530
• Other study ID #: CIBI333A101
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: February 27, 2023
• Est. completion date: April 25, 2024

Study information

• Verified date: March 2024
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 17
• Est. completion date: April 25, 2024
• Est. primary completion date: December 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Biological:
• IBI333
Intravitreal injection of IBI333

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerance indicators	Incidence, relatedness and severity of all adverse events (AE), treatment emergent adverse events (TEAE) and serious adverse events (SAE); Incidence of dose limiting toxicity;	Through study completion, a maximum of 24 weeks
Secondary	The area under the curve (AUC) of serum concentration of the drug after the administration.		Through study completion, a maximum of 24 weeks
Secondary	Maximum concentration (Cmax) of the drug after the administration.		Through study completion, a maximum of 24 weeks
Secondary	Time at which maximum concentration (Tmax) occurs for the drug after the administration.		Through study completion, a maximum of 24 weeks
Secondary	The half-life (t1/2) of drug after the administration .		Through study completion, a maximum of 24 weeks
Secondary	Number of participants with anti-drug antibodies or neutralizing antibodies .		Through study completion, a maximum of 24 weeks
Secondary	Changes of BCVA measured by ETDRS chart from baseline.		Through study completion, a maximum of 24 weeks
Secondary	Changes of CST measured by spectral domain optical coherence tomography (SD-OCT) from baseline.		Through study completion, a maximum of 24 weeks
Secondary	Proportion of subjects without intraretinal or subretinal fluid on SD-OCT.		Through study completion, a maximum of 24 weeks
Secondary	Change of height of pigment epithelial detachment from baseline on SD-OCT.		Through study completion, a maximum of 24 weeks