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

Innovent Biologics

Status and phase

Completed

Phase 1

Conditions

Neovascular Age-related Macular Degeneration

Treatments

Drug: IBI302 (the first dose level)

Drug: IBI302 (the second dose level)

Drug: Aflibercept

Study type

Interventional

Funder types

Industry

Identifiers

NCT04370379

CIBI302A102

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Inclusion criteria

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.

Exclusion criteria

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;