Trial to Evaluate the Safety and Tolerability of Repeated Intravitreal Injection of IBI302 in Neovascular AMD Patients

NCT04370379 | Completed Phase 1

• 1 other identifier: CIBI302A102
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed for multi-center, open-label, randomized, dose escalation phase I trial to evaluate the safety and tolerability of a multiple dose intravitreal injection of IBI302 in neovascular AMD patients.

Conditions

Neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

• Ocular safety, assessed by BCVA, slitlamp examination, ophthalmoscopy, IOP, fundus photography

  Baseline to Day140

• Incidence of adverse events

  Baseline to Day140

Secondary Outcomes (12)

• Changes in central subfield thickness by OCT compared with baseline

  Baseline to Day140

• Changes in CNV characteristics and CNV area by FA compared with baseline

  Baseline to Day140

• Changes in BCVA compared with baseline

  Baseline to Day140

• Positive rate of anti-drug antibody and neutralizing antibody of IBI302

  Baseline to Day140

• the area under the drug-time curve from 0 to time t of IBI302

  Baseline to Day140

Study Arms (3)

low dose of IBI302

EXPERIMENTAL

Drug: IBI302 (the first dose level)

high dose of IBI302

EXPERIMENTAL

Drug: IBI302 (the second dose level)

2mg aflibercept

ACTIVE COMPARATOR

Drug: Aflibercept

Interventions

IBI302 (the first dose level) DRUG

q4week (3 injections) followed by PRN dosing

low dose of IBI302

IBI302 (the second dose level) DRUG

q4week (3 injections) followed by PRN dosing

high dose of IBI302

Aflibercept DRUG

2mg, q4week (3 injections) followed by q8week

2mg aflibercept

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.
• Willing and able to sign informed consent form and comply with visit and study procedures per protocol.

You may not qualify if:

• Presence of uncontrolled glaucoma in the study eye (defined as IOP≥30mmHg despite the standardized treatment);
• Presence of active intraocular or periocular inflammation or infection;
• History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
• 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;
• Diabetic patients have any of the following conditions:HbA1c\>7.5% when screening;

Sponsors & Collaborators

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

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

Related Publications (1)

• Jia H, Li T, Sun J, Gong Y, Liu H, Wang H, Chen J, Liu W, Lu S, Feng L, Wan Q, Qian L, Wang F, Liu X, Sun X. A Novel Bispecific Fusion Protein Targeting C3b/C4b and VEGF in Patients With nAMD: A Randomized, Open-Label, Phase 1b Study. Am J Ophthalmol. 2023 Apr;248:8-15. doi: 10.1016/j.ajo.2022.11.016. Epub 2022 Nov 21.

  PMID: 36410472 DERIVED

MeSH Terms

Interventions

IBI302; aflibercept

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 30, 2020
• Study Start: May 28, 2020
• Primary Completion: April 30, 2021
• Study Completion: May 8, 2021
• Last Updated: November 11, 2021

Record last verified: 2021-11

Locations

CN (1)