Trial to Evaluate the Safety and Tolerability of Repeated Intravitreal Injection of IBI302 in Neovascular AMD Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: low dose of IBI302
|
Drug: IBI302 (the first dose level)
q4week (3 injections) followed by PRN dosing
|
| Experimental: high dose of IBI302
|
Drug: IBI302 (the second dose level)
q4week (3 injections) followed by PRN dosing
|
| Active Comparator: 2mg aflibercept
|
Drug: Aflibercept
2mg, q4week (3 injections) followed by q8week
|
Outcome Measures
Primary Outcome Measures
- Ocular safety, assessed by BCVA, slitlamp examination, ophthalmoscopy, IOP, fundus photography [Baseline to Day140]
- Incidence of adverse events [Baseline to Day140]
Secondary Outcome Measures
- 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]
- the area under the curve at the time of 0-infinity of IBI302 [Baseline to Day140]
- The peak concentration of IBI302 [Baseline to Day140]
- The peak time of IBI302 [Baseline to Day140]
- Clearance rate of IBI302 [Baseline to Day140]
- Half-life of IBI302 [Baseline to Day140]
- VEGF concentration [Baseline to Day140]
- Concentration of complement fragments [Baseline to Day140]
Eligibility Criteria
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;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai General Hospital | Shanghai | Shanghai | China | 200080 |
Sponsors and Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIBI302A102