Trial to Evaluate the Safety and Tolerability of Repeated Intravitreal Injection of IBI302 in Neovascular AMD Patients

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of IBI302 in Patients With Neovascular Age-related Macular Degeneration (nAMD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04370379
• Other study ID #: CIBI302A102
• Status: Completed
• Phase: Phase 1
• Start date: May 28, 2020
• Est. completion date: May 8, 2021

Study information

• Verified date: November 2021
• 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, randomized, dose escalation phase I trial to evaluate the safety and tolerability of a multiple dose intravitreal injection of IBI302 in neovascular AMD patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 8, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

Inclusion criteria

1. Male or female patient = 50 yrs. of age.

2. Active subfoveal or parafoveal CNV secondary to neovascular AMD.

3. Willing and able to sign informed consent form and comply with visit and study procedures per protocol.

Exclusion criteria

1. Presence of uncontrolled glaucoma in the study eye (defined as IOP=30mmHg despite the standardized treatment);

2. Presence of active intraocular or periocular inflammation or infection;

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

4. Participated in any clinical study of any other drug within three months prior to enrollment, or attempted to participate in other drug trials during the study;

5. Diabetic patients have any of the following conditions:HbA1c>7.5% when screening;

Related Conditions & MeSH terms

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

Intervention

Drug:
• IBI302 (the first dose level)
q4week (3 injections) followed by PRN dosing
• IBI302 (the second dose level)
q4week (3 injections) followed by PRN dosing
• Aflibercept
2mg, q4week (3 injections) followed by q8week

Locations

Country	Name	City	State
China	Shanghai General Hospital	Shanghai	Shanghai

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	Ocular safety, assessed by BCVA, slitlamp examination, ophthalmoscopy, IOP, fundus photography		Baseline to Day140
Primary	Incidence of adverse events		Baseline to Day140
Secondary	Changes in central subfield thickness by OCT compared with baseline		Baseline to Day140
Secondary	Changes in CNV characteristics and CNV area by FA compared with baseline		Baseline to Day140
Secondary	Changes in BCVA compared with baseline		Baseline to Day140
Secondary	Positive rate of anti-drug antibody and neutralizing antibody of IBI302		Baseline to Day140
Secondary	the area under the drug-time curve from 0 to time t of IBI302		Baseline to Day140
Secondary	the area under the curve at the time of 0-infinity of IBI302		Baseline to Day140
Secondary	The peak concentration of IBI302		Baseline to Day140
Secondary	The peak time of IBI302		Baseline to Day140
Secondary	Clearance rate of IBI302		Baseline to Day140
Secondary	Half-life of IBI302		Baseline to Day140
Secondary	VEGF concentration		Baseline to Day140
Secondary	Concentration of complement fragments		Baseline to Day140