Neovascular Age-related Macular Degeneration
Conditions
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).
Interventions
BIOLOGICALIBI333
Intravitreal injection of IBI333
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Willing and able to sign informed consent form and comply with visit and study procedures per protocol. 2. Male or female patients ≥ 50 yrs. of age. 3. Active CNV lesions secondary to neovascular AMD. 4. BCVA score of 19-78 letters using ETDRS charts in the study eye. 5. 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
1. Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results; 2. Tractional retinal detachment, pre-retinal fibrosis, vitreomacular traction, or epiretinal membrane involving the fovea or disrupting the macular structure in the study eye; 3. Active ocular or periocular inflammation/infection in either eye; 4. Prior any treatment of following in the study eye: 1. Anti-VEGF therapy within 90 days prior to screening; 2. Intraocular glucocorticoid injection within 180 days prior to screening; 3. Laser photocoagulation or photodynamic therapy within 90 days prior to screening; 4. Intraocular surgery within 90 days prior to screening; 5. Laser posterior capsulotomy, laser trabeculectomy or laser peripheral iridectomy within 30 days prior to screening; 5. Glycated hemoglobin (HbA1c) \> 8% within 28 days prior to screening; 6. Uncontrolled hypertension (defined as systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg); 7. Systemic administration of steroids within 30 days prior to screening; 8. Systemic administration of anti-VEGF drugs within 90 days prior to screening; 9. History of severe hypersensitivity/allergic to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine; 10. 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; 11. Other conditions unsuitable for enrollment judged by investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerance indicators | Through study completion, a maximum of 24 weeks | 1. Incidence, relatedness and severity of all adverse events (AE), treatment emergent adverse events (TEAE) and serious adverse events (SAE); 2. Incidence of dose limiting toxicity; |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| The area under the curve (AUC) of serum concentration of the drug after the administration. | 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 |
| Changes of BCVA measured by ETDRS chart from baseline. | Through study completion, a maximum of 24 weeks |
Countries
China
Outcome results
None listed