Neovascular Age-related Macular Degeneration
Conditions
Brief summary
This study is designed for Open-label, multi-center, single-arm Phase II trail to evaluate the efficacy and safety of intravitreal injection of IBI302 in nAMD patients.
Interventions
DRUGIBI302 8mg dose
8 mg IBI302 will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks.
Sponsors
Innovent Biologics Technology Limited (Shanghai R&D Center)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have signed an informed consent form before participating in the research. 2. Male or female individuals aged 50 or above at the time of signing the informed consent form; 3. Active CNV under the macular fovea secondary to nAMD or active CNV involving the macular fovea. 4. At baseline, the BCVA of the study eye was within the range of 19 to 78 ETDRS letters (including both ends).
Exclusion criteria
1. According to the investigator's judgment, concomitant ocular diseases/systemic diseases of the study eyes at screening or baseline may lead to participants' non-response to the study treatment or confuse the interpretation of the study results; 2. The study eye has uncontrollable glaucoma; 3. There is an active intraocular or periocular infection or inflammation in either eye; 4. The non-study eye has severe visual function disorders; 5. Within 90 days before baseline, the study eye had received anti-VEGF treatment; 6. Within 90 days before baseline, the study eye had received anti-complement treatment; 7. At any time before baseline, the study eye had received IBI302 treatment; 8. Uncontrollable hypertension; 9. Glycated hemoglobin (HbA1c) \> 10.0% within 28 days prior to screening; 10. Other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants whose best corrected visual acuity (BCVA) of the study eye decreased by less than 15 letters from baseline as measured by the visual acuity chart in the early treatment diabetic retinopathy study (ETDRS) at week 52 | Week52 |
Secondary
| Measure | Time frame |
|---|---|
| The changes in BCVA from baseline at each visit | Baseline，Weeks 4，8，12，16，20，24，28，32，36，40，44，48 and 52 |
| Proportion of patients with BCVA improvement of ≥0, ≥5, ≥10, and ≥15 ETDRS letters from baseline at week 52 | Week52 |
| Proportion of participants with a decrease in BCVA of >0, ≥5, ≥10, and ≥15 ETDRS letters from baseline at week 52 | Week52 |
| The change in central subfield thickness of the macula measured by OCT from the baseline at week 52 | Week52 |
| Proportion of participants with IRF/SRF/Pigment epithelial detachment (PED) on OCT at Week 52 | Week52 |
| Change in choroidal neovascularization (CNV) area on fundus fluorescein angiography (FFA) at week 52 compared to baseline | Week52 |
| Change in CNV leakage area on FFA at week 52 compared to baseline | Week52 |
| Proportion of participants with new-onset MA on OCT at Week 52 | Week52 |
| Proportion of new-onset fibrosis on color fundus photography (CFP) at Week 52 | Week52 |
| Change in MA area on OCT from baseline at Week 52 | Week52 |
| Change in fibrosis area and maximum lesion diameter on CFP from baseline at Week 52 | Week52 |
| The incidence rate, correlation with the studied drugs, and severity of ocular and systemic adverse events (AE), treatment emergent adverse events (TEAE), and serious adverse events (SAE) | From baseline through Week 52 |
| The production of anti-drug antibodies in the serum | Day0、Week4、Week16、Week32、Week48、Week52 |
Countries
China
Contacts
Primary ContactYating Liu
Outcome results
None listed