Clinical trial NCT04370379: Trial to Evaluate the Safety and Tolerability of Repeated Intravitreal Injection of IBI302 in Neovascular AMD Patients
Official title: A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of IBI302 in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neovascular Age-related Macular Degeneration
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-04-30
Enrollment: 18
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

Inclusion criteria

1. Male or female patient ≥ 50 yrs. of age.
2. Active subfoveal or parafoveal CNV secondary to neovascular AMD.
3. Willing and able to sign informed consent form and comply with visit and study procedures per protocol.

Exclusion criteria

1. Presence of uncontrolled glaucoma in the study eye (defined as IOP≥30mmHg despite the standardized treatment);
2. Presence of active intraocular or periocular inflammation or infection;
3. History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
4. 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;
5. Diabetic patients have any of the following conditions:HbA1c\>7.5% when screening;

Primary outcomes:
measure: Ocular safety, assessed by BCVA, slitlamp examination, ophthalmoscopy, IOP, fundus photography
timeFrame: Baseline to Day140
measure: Incidence of adverse events
timeFrame: Baseline to Day140
Secondary outcomes:
measure: Changes in central subfield thickness by OCT compared with baseline
timeFrame: Baseline to Day140
measure: Changes in CNV characteristics and CNV area by FA compared with baseline
timeFrame: Baseline to Day140
measure: Changes in BCVA compared with baseline
timeFrame: Baseline to Day140
measure: Positive rate of anti-drug antibody and neutralizing antibody of IBI302
timeFrame: Baseline to Day140
measure: the area under the drug-time curve from 0 to time t of IBI302
timeFrame: Baseline to Day140
measure: the area under the curve at the time of 0-infinity of IBI302
timeFrame: Baseline to Day140
measure: The peak concentration of IBI302
timeFrame: Baseline to Day140
measure: The peak time of IBI302
timeFrame: Baseline to Day140
measure: Clearance rate of IBI302
timeFrame: Baseline to Day140
measure: Half-life of IBI302
timeFrame: Baseline to Day140
measure: VEGF concentration
timeFrame: Baseline to Day140
measure: Concentration of complement fragments
timeFrame: Baseline to Day140
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
Study officials:
References: