Evaluation of IBI302 Injection in nAMD or DME

NCT05961007 | Suspended Phase 1

• 1 other identifier: CIBI302B201
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neovascular Age-related Macular Degeneration; Diabetic Macular Edema

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change of BCVA from baseline by visit

  through study completion，an average of 20 weeks

• Change of CST from baseline by visit

  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

  through study completion，an average of 20 weeks

Study Arms (2)

Aflibercept

ACTIVE COMPARATOR

only phase II

Drug: Intravitreal injection of Aflibercept

IBI302

EXPERIMENTAL

Biological: Intravitreal injection of IBI302(dose 1); Biological: Intravitreal injection of IBI302(dose 2); Biological: Intravitreal injection of IBI302(dose 3)

Interventions

Intravitreal injection of IBI302(dose 1) BIOLOGICAL

IBI302(dose 1) intravitreal injection given as protocol

IBI302

Intravitreal injection of IBI302(dose 2) BIOLOGICAL

IBI302(dose 2) intravitreal injection given as protocol

IBI302

Intravitreal injection of IBI302(dose 3) BIOLOGICAL

IBI302(dose 3) intravitreal injection given as protocol

IBI302

Intravitreal injection of Aflibercept DRUG

Aflibercept intravitreal injection given as protocol

Aflibercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to sign informed consent form and comply with visit and study procedures per protocol;
• Male or female patiensubjects ≥ 18 yrs. of age;
• For AMD subjects, active subfoveal or parafoveal CNV secondary to neovascular AMD; the vision decreased by nAMD;
• 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;
• BCVA ETDRS letter score of 24-73 in the study eye;

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 ;
• 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;
• Laser photocoagulation;
• History of vitreoretinal surgery;
• Glucocorticoid treatment(intravitreal or peribulbar) ;
• BCVA score \<19 letters in the fellow eye;
• Anti-VEGF therapy in the fellow eye within 30 days of day 0;
• 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;
• 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 90 days of day 0, or attempted to participate in other drug trials during the study;
• Other conditions unsuitable for enrollment judged by investigatiors.

Sponsors & Collaborators

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

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Masking participant and investorgastor
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: July 27, 2023
• Study Start: November 18, 2021
• Primary Completion: October 31, 2023
• Study Completion: April 30, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)