A Study of IBI302 in Patients With nAMD

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

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.

Study Overview

• Status: Completed
• Conditions: Neovascular Age-related Macular Degeneration
• Intervention / Treatment: Biological: High dose IBI302; Drug: Aflibercept; Biological: Low dose IBI302

• Study Type: Interventional
• Enrollment (Actual): 231
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215123
      • Innovent Biologics (Suzhou) Co,Ltd.

Participation Criteria

Eligibility Criteria

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

Description

Inclusion criteria

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

Exclusion criteria

1. Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results;
2. Presence of uncontrolled glaucoma in the study eye (defined as IOP≥25mmHg despite the standardized treatment);
3. Presence of active intraocular or periocular inflammation or infection;

4. 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;
5. 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;
6. History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
7. Pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period;
8. 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;
9. Other conditions unsuitable for enrollment judged by investigators

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cohort 1 IBI302 treated with high dose level of IBI302; Drug: IBI302 4mg/eye;Intraocular injection	Biological: High dose IBI302; High dose IBI302 intravitreal injection given as every other month after three loading monthly injection
Active Comparator: Aflibercept; Drug: Aflibercept 2mg/eye;Intraocular injection	Drug: Aflibercept; Intraocular injection
Experimental: cohort 1 IBI302 treated with low dose level of IBI302; Drug: IBI302 2mg/eye;Intraocular injection	Biological: Low dose IBI302; Low dose IBI302 intravitreal injection given as every other month after three loading monthly injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The visual efficacy of IBI302	Baseline to week 36

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
other visual effects of IBI302	the proportion if BCVA improvement ≥0,5,10 or 15 letters at week 12, 28, 36 and 52.	Baseline to week 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	Baseline to week 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	Baseline to week 52
the safety of IBI302	the incidence of ocular AE or any systemic AE, TEAE, SAE	Baseline to week 52
Immunogenicity of IBI302	the positive rate of anti-drug antibody and neutralizing antibody	Baseline to week 52

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2021
• Primary Completion (Actual): January 13, 2023
• Study Completion (Actual): January 13, 2023

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration; Wet Macular Degeneration; Antineoplastic Agents; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: CIBI302A201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No