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A Study of IBI302 in Patients With nAMD

Primary Purpose

Neovascular Age-related Macular Degeneration

Status

Active

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Low dose IBI302

High dose IBI302

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

Male or female patient ≥ 50 yrs. of age.
Active subfoveal or parafoveal CNV secondary to neovascular AMD.
BCVA score of 24-73 letters using ETDRS charts in the study eye.
Willing and able to sign informed consent form and comply with visit and study procedures per protocol.

Exclusion criteria

Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results;
Presence of uncontrolled glaucoma in the study eye (defined as IOP≥25mmHg despite the standardized treatment);
Presence of active intraocular or periocular inflammation or infection;
Prior any treatment of following in the study eye:
1. Anti-VEGF therapy or anti-complement therapy within 3 months prior to screening;
2. Laser photocoagulation within 3 months prior to screening;
3. Photodynamic therapy or vitreoretinal surgery;
4. Intraocular glucocorticoid injection within 6 months prior to enrollment;
Presence of any systemic disease: including but not limited toactive infections (such as active viral hepatitis); unstable angina; cerebrovascular accident or transient cerebral ischemia (within 6 months prior to selection); myocardial infarction (within 6 months prior to selection); serious arrhythmia requiring medical treatment; liver, kidney or metabolic diseases; or malignant tumor;
History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
Pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period;
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;
Other conditions unsuitable for enrollment judged by investigators

Sites / Locations

Innovent Biologics (Suzhou) Co,Ltd.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

cohort 1 IBI302 treated with high dose level of IBI302

Aflibercept

cohort 1 IBI302 treated with low dose level of IBI302

Arm Description

Drug: IBI302 4mg/eye;Intraocular injection

Drug: Aflibercept 2mg/eye;Intraocular injection

Drug: IBI302 2mg/eye;Intraocular injection

Outcomes

Primary Outcome Measures

The visual efficacy of IBI302

Secondary Outcome Measures

other visual effects of IBI302

the proportion if BCVA improvement ≥0,5,10 or 15 letters at week 12, 28, 36 and 52.

the anatomical effects of IBI302 on OCT

the mean change of central subfield thickness from BL to week 52 at week 12, 28, 36 and 52

the anatomical effects of IBI302 on FFA

the change of CNV area, CNV leakage area, total lesion area from BL to week 36 or 52

the safety of IBI302

the incidence of ocular AE or any systemic AE, TEAE, SAE

Immunogenicity of IBI302

the positive rate of anti-drug antibody and neutralizing antibody

Full Information

NCT ID

NCT04820452

First Posted

March 25, 2021

Last Updated

September 12, 2022

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04820452

Brief Title

A Study of IBI302 in Patients With nAMD

Official Title

A Multi-center, Randomized, Double-blind, Active-controlled Phase II Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With Neovascular Age-related Macular Degeneration

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 28, 2021 (Actual)

Primary Completion Date

March 31, 2023 (Anticipated)

Study Completion Date

May 31, 2023 (Anticipated)

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 is a multi-center, randomized, double-blind, active-controlled study to evaluate the efficacy and safety of IBI302 in subjects with neovascular age-related macular degeneration.

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 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

231 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

cohort 1 IBI302 treated with high dose level of IBI302

Arm Type

Experimental

Arm Description

Drug: IBI302 4mg/eye;Intraocular injection

Arm Title

Aflibercept

Arm Type

Active Comparator

Arm Description

Drug: Aflibercept 2mg/eye;Intraocular injection

Arm Title

cohort 1 IBI302 treated with low dose level of IBI302

Arm Type

Experimental

Arm Description

Drug: IBI302 2mg/eye;Intraocular injection

Intervention Type

Biological

Intervention Name(s)

Low dose IBI302

Intervention Description

Low dose IBI302 intravitreal injection given as every other month after three loading monthly injection

Intervention Type

Biological

Intervention Name(s)

High dose IBI302

Intervention Description

High dose IBI302 intravitreal injection given as every other month after three loading monthly injection

Intervention Type

Drug

Intervention Name(s)

Aflibercept

Intervention Description

Intraocular injection

Primary Outcome Measure Information:

Title

The visual efficacy of IBI302

Time Frame

Baseline to week 36

Secondary Outcome Measure Information:

Title

other visual effects of IBI302

Description

the proportion if BCVA improvement ≥0,5,10 or 15 letters at week 12, 28, 36 and 52.

Time Frame

Baseline to week 52

Title

the anatomical effects of IBI302 on OCT

Description

the mean change of central subfield thickness from BL to week 52 at week 12, 28, 36 and 52

Time Frame

Baseline to week 52

Title

the anatomical effects of IBI302 on FFA

Description

the change of CNV area, CNV leakage area, total lesion area from BL to week 36 or 52

Time Frame

Baseline to week 52

Title

the safety of IBI302

Description

the incidence of ocular AE or any systemic AE, TEAE, SAE

Time Frame

Baseline to week 52

Title

Immunogenicity of IBI302

Description

the positive rate of anti-drug antibody and neutralizing antibody

Time Frame

Baseline to week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria Male or female patient ≥ 50 yrs. of age. Active subfoveal or parafoveal CNV secondary to neovascular AMD. BCVA score of 24-73 letters using ETDRS charts in the study eye. Willing and able to sign informed consent form and comply with visit and study procedures per protocol. Exclusion criteria Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results; Presence of uncontrolled glaucoma in the study eye (defined as IOP≥25mmHg despite the standardized treatment); Presence of active intraocular or periocular inflammation or infection; Prior any treatment of following in the study eye: Anti-VEGF therapy or anti-complement therapy within 3 months prior to screening; Laser photocoagulation within 3 months prior to screening; Photodynamic therapy or vitreoretinal surgery; Intraocular glucocorticoid injection within 6 months prior to enrollment; Presence of any systemic disease: including but not limited toactive infections (such as active viral hepatitis); unstable angina; cerebrovascular accident or transient cerebral ischemia (within 6 months prior to selection); myocardial infarction (within 6 months prior to selection); serious arrhythmia requiring medical treatment; liver, kidney or metabolic diseases; or malignant tumor; History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine; Pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period; 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; Other conditions unsuitable for enrollment judged by investigators

Facility Information:

Facility Name

Innovent Biologics (Suzhou) Co,Ltd.

City

Suzhou

State/Province

Jiangsu

ZIP/Postal Code

215123

Country

China

12. IPD Sharing Statement

Learn more about this trial

A Study of IBI302 in Patients With nAMD

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