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

Phase 1

Completed

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Drug: IBI302 (the second dose level); Drug: IBI302 (the first dose level); Drug: Aflibercept

• Registration Number: NCT04370379
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-24
• Study First Submitted QC: 2020-04-29
• Study First Posted: 2020-04-30
• Study Start: 2020-05-28
• Primary Completion: 2021-04-30
• Study Completion: 2021-05-08
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-10
• Last Update Posted: 2021-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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;

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high dose of IBI302	IBI302 (the second dose level)	-
low dose of IBI302	IBI302 (the first dose level)	-
2mg aflibercept	Aflibercept	-

Primary Outcome Measures

Name	Time	Method
Ocular safety, assessed by BCVA, slitlamp examination, ophthalmoscopy, IOP, fundus photography	Baseline to Day140
Incidence of adverse events	Baseline to Day140

Secondary Outcome Measures

Name	Time	Method
Changes in central subfield thickness by OCT compared with baseline	Baseline to Day140
Changes in CNV characteristics and CNV area by FA compared with baseline	Baseline to Day140
Changes in BCVA compared with baseline	Baseline to Day140
the area under the curve at the time of 0-infinity of IBI302	Baseline to Day140
Positive rate of anti-drug antibody and neutralizing antibody of IBI302	Baseline to Day140
the area under the drug-time curve from 0 to time t of IBI302	Baseline to Day140
The peak concentration of IBI302	Baseline to Day140
The peak time of IBI302	Baseline to Day140
Clearance rate of IBI302	Baseline to Day140
Half-life of IBI302	Baseline to Day140
VEGF concentration	Baseline to Day140
Concentration of complement fragments	Baseline to Day140

Trial Locations

Locations (1)

Shanghai General Hospital; 🇨🇳 Shanghai, Shanghai, China