Evaluation of IBI302 Injection in nAMD or DME

A Dose Escalation Study to Evaluate the Safety and Tolerability of IBI302 Intravitreal Injection in Subjects With Neovascular Age-related Macular Degeneration and Diabetic Macular Edema AND A Multi-center, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With Diabetic Macular Edema

The purpose of this study is to determine the efficacy and safety of intravitreal IBI302 in the treatment of subjects with neovascular age-related macular degeneration (only in Phase I) or diabetic macular edema.

Study Overview

• Status: Suspended
• Conditions: Diabetic Macular Edema; Neovascular Age-related Macular Degeneration
• Intervention / Treatment: Drug: Intravitreal injection of Aflibercept; Biological: Intravitreal injection of IBI302(dose 1); Biological: Intravitreal injection of IBI302(dose 2); Biological: Intravitreal injection of IBI302(dose 3)

• Study Type: Interventional
• Enrollment (Estimated): 234
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

1. Willing and able to sign informed consent form and comply with visit and study procedures per protocol;
2. Male or female patiensubjects ≥ 18 yrs. of age;
3. For AMD subjects, active subfoveal or parafoveal CNV secondary to neovascular AMD; the vision decreased by nAMD;
4. For DME subjects, Type 1 or type 2 diabetes mellitus, decrease in vision determined to be primarily the result of DME in the study eye; the CST measurement of ≥ 280 μm in the study eye;
5. BCVA ETDRS letter score of 24-73 in the study eye;

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 ;
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;
   2. Laser photocoagulation;
   3. History of vitreoretinal surgery;
   4. Glucocorticoid treatment(intravitreal or peribulbar) ;
5. BCVA score <19 letters in the fellow eye;
6. Anti-VEGF therapy in the fellow eye within 30 days of day 0;
7. Presence of any systemic disease: including but not limited to active infections (such as active viral hepatitis); unstable angina; cerebrovascular accident or transient cerebral ischemia (within 6 months prior to screening); myocardial infarction (within 6 months prior to screening; serious arrhythmia requiring medical treatment; liver, kidney or metabolic diseases; uncontrolled clinical disease(such as diabetes mellitus, hypertension) or malignant tumor;
8. History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
9. Pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period;
10. Participated in any clinical study of any other drug within 90 days of day 0, or attempted to participate in other drug trials during the study;
11. Other conditions unsuitable for enrollment judged by investigatiors.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aflibercept; only phase II	Drug: Intravitreal injection of Aflibercept; Aflibercept intravitreal injection given as protocol
Experimental: IBI302	Biological: Intravitreal injection of IBI302(dose 1); IBI302(dose 1) intravitreal injection given as protocol; Biological: Intravitreal injection of IBI302(dose 2); IBI302(dose 2) intravitreal injection given as protocol; Biological: Intravitreal injection of IBI302(dose 3); IBI302(dose 3) intravitreal injection given as protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of ocular and non-ocular adverse events.	To evaluate the number of subjects with ocular and non-ocular adverse events, treatment emergent adverse event, adverse event of special interest, serious adverse events; number of subjects with clinical significant abnormal laboratory values, electrocardiograms (pre and post infusions), abnormal vital signs, ophthalmic and physical examinations.	Up to week 20
DLT in each group		7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of BCVA from baseline by visit	Best corrected visual acuity (BCVA) was measured on early treatment diabetic retinopathy study(ETDRS) chart at a starting distance of 4 meters. The BCVAletter score ranges from 0 to 100(best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.	through study completion，an average of 20 weeks
Change of CST from baseline by visit	Central subfield thickness（CST） was defined as the distance between the internal limiting member and the Bruch's member using OCT, as assessed by the central reading.	through study completion，an average of 20 weeks
Area under the concentration time curve (AUC) and Maximum plasma concentration (Cmax)		through study completion，an average of 20 weeks
The ADA and neutralizing antibody	Blood samples were obtained for measurement of anti-drug antibodies (ADAs) to IBI302 by a validated enzyme-linked immunosorbent assay (ELISA).	through study completion，an average of 20 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2021
• Primary Completion (Estimated): October 31, 2023
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: November 15, 2021
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Wet Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: CIBI302B201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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