NCT04820452

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
231

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

April 28, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2023

Completed
Last Updated

November 18, 2024

Status Verified

November 1, 2024

Enrollment Period

1.7 years

First QC Date

March 25, 2021

Last Update Submit

November 15, 2024

Conditions

Neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • The visual efficacy of IBI302

    Baseline to week 36

Secondary Outcomes (5)

  • other visual effects of IBI302

    Baseline to week 52

  • the anatomical effects of IBI302 on OCT

    Baseline to week 52

  • the anatomical effects of IBI302 on FFA

    Baseline to week 52

  • the safety of IBI302

    Baseline to week 52

  • Immunogenicity of IBI302

    Baseline to week 52

Study Arms (3)

cohort 1 IBI302 treated with high dose level of IBI302

EXPERIMENTAL

Drug: IBI302 4mg/eye;Intraocular injection

Biological: High dose IBI302

Aflibercept

ACTIVE COMPARATOR

Drug: Aflibercept 2mg/eye;Intraocular injection

Drug: Aflibercept

cohort 1 IBI302 treated with low dose level of IBI302

EXPERIMENTAL

Drug: IBI302 2mg/eye;Intraocular injection

Biological: Low dose IBI302

Interventions

Low dose IBI302BIOLOGICAL

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

cohort 1 IBI302 treated with low dose level of IBI302
High dose IBI302BIOLOGICAL

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

cohort 1 IBI302 treated with high dose level of IBI302
AfliberceptDRUG

Intraocular injection

Aflibercept

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innovent Biologics (Suzhou) Co,Ltd.

Suzhou, Jiangsu, 215123, China

Location

MeSH Terms

Interventions

IBI302aflibercept

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2021

First Posted

March 29, 2021

Study Start

April 28, 2021

Primary Completion

January 13, 2023

Study Completion

January 13, 2023

Last Updated

November 18, 2024

Record last verified: 2024-11

Locations

CN(1)