Neovascular Age-related Macular Degeneration
Conditions
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.
Interventions
DRUGIBI302 (the first dose level)
q4week (3 injections) followed by PRN dosing
DRUGIBI302 (the second dose level)
q4week (3 injections) followed by PRN dosing
DRUGAflibercept
2mg, q4week (3 injections) followed by q8week
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ocular safety, assessed by BCVA, slitlamp examination, ophthalmoscopy, IOP, fundus photography | Baseline to Day140 |
| Incidence of adverse events | Baseline to Day140 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Changes in CNV characteristics and CNV area by FA compared with baseline | 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 |
| The peak time of IBI302 | Baseline to Day140 |
| Changes in central subfield thickness by OCT compared with baseline | Baseline to Day140 |
Countries
China
Outcome results
None listed