Back to results

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

Primary Purpose

Neovascular Age-related Macular Degeneration

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

IBI302 (the first dose level)

IBI302 (the second dose level)

Aflibercept

About this trial

This is an interventional treatment trial for Neovascular Age-related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Inclusion criteria

Male or female patient ≥ 50 yrs. of age.
Active subfoveal or parafoveal CNV secondary to neovascular AMD.
Willing and able to sign informed consent form and comply with visit and study procedures per protocol.

Exclusion criteria

Presence of uncontrolled glaucoma in the study eye (defined as IOP≥30mmHg despite the standardized treatment);
Presence of active intraocular or periocular inflammation or infection;
History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
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;
Diabetic patients have any of the following conditions:HbA1c>7.5% when screening;

Sites / Locations

Shanghai General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

low dose of IBI302

high dose of IBI302

2mg aflibercept

Arm Description

Outcomes

Primary Outcome Measures

Ocular safety, assessed by BCVA, slitlamp examination, ophthalmoscopy, IOP, fundus photography

Incidence of adverse events

Secondary Outcome Measures

Changes in central subfield thickness by OCT compared with baseline

Changes in CNV characteristics and CNV area by FA compared with baseline

Changes in BCVA compared with baseline

Positive rate of anti-drug antibody and neutralizing antibody of IBI302

the area under the drug-time curve from 0 to time t of IBI302

the area under the curve at the time of 0-infinity of IBI302

The peak concentration of IBI302

The peak time of IBI302

Clearance rate of IBI302

Half-life of IBI302

VEGF concentration

Concentration of complement fragments

Full Information

NCT ID

NCT04370379

First Posted

April 24, 2020

Last Updated

November 10, 2021

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04370379

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

May 28, 2020 (Actual)

Primary Completion Date

April 30, 2021 (Actual)

Study Completion Date

May 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neovascular Age-related Macular Degeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

low dose of IBI302

Arm Type

Experimental

Arm Title

high dose of IBI302

Arm Type

Experimental

Arm Title

2mg aflibercept

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

IBI302 (the first dose level)

Intervention Description

q4week (3 injections) followed by PRN dosing

Intervention Type

Drug

Intervention Name(s)

IBI302 (the second dose level)

Intervention Description

q4week (3 injections) followed by PRN dosing

Intervention Type

Drug

Intervention Name(s)

Aflibercept

Intervention Description

2mg, q4week (3 injections) followed by q8week

Primary Outcome Measure Information:

Title

Ocular safety, assessed by BCVA, slitlamp examination, ophthalmoscopy, IOP, fundus photography

Time Frame

Baseline to Day140

Title

Incidence of adverse events

Time Frame

Baseline to Day140

Secondary Outcome Measure Information:

Title

Changes in central subfield thickness by OCT compared with baseline

Time Frame

Baseline to Day140

Title

Changes in CNV characteristics and CNV area by FA compared with baseline

Time Frame

Baseline to Day140

Title

Changes in BCVA compared with baseline

Time Frame

Baseline to Day140

Title

Positive rate of anti-drug antibody and neutralizing antibody of IBI302

Time Frame

Baseline to Day140

Title

the area under the drug-time curve from 0 to time t of IBI302

Time Frame

Baseline to Day140

Title

the area under the curve at the time of 0-infinity of IBI302

Time Frame

Baseline to Day140

Title

The peak concentration of IBI302

Time Frame

Baseline to Day140

Title

The peak time of IBI302

Time Frame

Baseline to Day140

Title

Clearance rate of IBI302

Time Frame

Baseline to Day140

Title

Half-life of IBI302

Time Frame

Baseline to Day140

Title

VEGF concentration

Time Frame

Baseline to Day140

Title

Concentration of complement fragments

Time Frame

Baseline to Day140

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Inclusion criteria Male or female patient ≥ 50 yrs. of age. Active subfoveal or parafoveal CNV secondary to neovascular AMD. Willing and able to sign informed consent form and comply with visit and study procedures per protocol. Exclusion criteria Presence of uncontrolled glaucoma in the study eye (defined as IOP≥30mmHg despite the standardized treatment); Presence of active intraocular or periocular inflammation or infection; History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine; 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; Diabetic patients have any of the following conditions:HbA1c>7.5% when screening;

Facility Information:

Facility Name

Shanghai General Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200080

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs