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

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

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.

Study Overview

• Status: Completed
• Conditions: Neovascular Age-related Macular Degeneration
• Intervention / Treatment: Drug: IBI302 (the first dose level); Drug: IBI302 (the second dose level); Drug: Aflibercept

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200080
      • Shanghai General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: low dose of IBI302	Drug: IBI302 (the first dose level); q4week (3 injections) followed by PRN dosing
Experimental: high dose of IBI302	Drug: IBI302 (the second dose level); q4week (3 injections) followed by PRN dosing
Active Comparator: 2mg aflibercept	Drug: Aflibercept; 2mg, q4week (3 injections) followed by q8week

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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 area under the curve at the time of 0-infinity 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

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2020
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): May 8, 2021

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 10, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Wet Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: CIBI302A102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No