Study of IBI333 in Subjects With Neovascular Age-related Macular Degeneration
Study Details
Study Description
Brief Summary
This study is designed for multi-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single and multiple intravitreal injection of IBI333 in subjects with neovascular age-related macular degeneration (nAMD).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: :treated with different doses of single intravitreal injections of IBI333 Biological: IBI333 Dose 1 IBI333 of single IVT injections， Biological: IBI333 Dose 2 IBI333 of single IVT injections |
Biological: IBI333
Intravitreal injection of IBI333
|
| Experimental: treated with different doses of multiple intravitreal injections of IBI333 Biological: IBI333 Dose 3 IBI333 of multiple IVT injections， Biological: IBI333 Dose 4 IBI333 of multiple IVT injections |
Biological: IBI333
Intravitreal injection of IBI333
|
Outcome Measures
Primary Outcome Measures
- Safety and tolerance indicators [Through study completion, a maximum of 24 weeks]
Incidence, relatedness and severity of all adverse events (AE), treatment emergent adverse events (TEAE) and serious adverse events (SAE); Incidence of dose limiting toxicity;
Secondary Outcome Measures
- The area under the curve (AUC) of serum concentration of the drug after the administration. [Through study completion, a maximum of 24 weeks]
- Maximum concentration (Cmax) of the drug after the administration. [Through study completion, a maximum of 24 weeks]
- Time at which maximum concentration (Tmax) occurs for the drug after the administration. [Through study completion, a maximum of 24 weeks]
- The half-life (t1/2) of drug after the administration . [Through study completion, a maximum of 24 weeks]
- Number of participants with anti-drug antibodies or neutralizing antibodies . [Through study completion, a maximum of 24 weeks]
- Changes of BCVA measured by ETDRS chart from baseline. [Through study completion, a maximum of 24 weeks]
- Changes of CST measured by spectral domain optical coherence tomography (SD-OCT) from baseline. [Through study completion, a maximum of 24 weeks]
- Proportion of subjects without intraretinal or subretinal fluid on SD-OCT. [Through study completion, a maximum of 24 weeks]
- Change of height of pigment epithelial detachment from baseline on SD-OCT. [Through study completion, a maximum of 24 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
-
Male or female patients ≥ 50 yrs. of age.
-
Active CNV lesions secondary to neovascular AMD.
-
BCVA score of 19-78 letters using ETDRS charts in the study eye.
-
Female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 6 months after the end of treatment.
Exclusion Criteria:
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Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results;
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Tractional retinal detachment, pre-retinal fibrosis, vitreomacular traction, or epiretinal membrane involving the fovea or disrupting the macular structure in the study eye;
-
Active ocular or periocular inflammation/infection in either eye;
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Prior any treatment of following in the study eye:
-
Anti-VEGF therapy within 90 days prior to screening;
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Intraocular glucocorticoid injection within 180 days prior to screening;
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Laser photocoagulation or photodynamic therapy within 90 days prior to screening;
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Intraocular surgery within 90 days prior to screening;
-
Laser posterior capsulotomy, laser trabeculectomy or laser peripheral iridectomy within 30 days prior to screening;
-
Glycated hemoglobin (HbA1c) > 8% within 28 days prior to screening;
-
Uncontrolled hypertension (defined as systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg);
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Systemic administration of steroids within 30 days prior to screening;
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Systemic administration of anti-VEGF drugs within 90 days prior to screening;
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History of severe hypersensitivity/allergic 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 90 days prior to enrollment, or attempted to participate in other drug trials during the study;
-
Other conditions unsuitable for enrollment judged by investigators.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking Union Medical College Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing | China | 101199 |
Sponsors and Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIBI333A101