neovascular age-related macular degeneration
Conditions
Interventions
Test group:IBI302 8mg/intravitreal injection
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
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
Exclusion criteria: Ocular diseases 1. According to the investigator's judgment, concomitant ocular diseases/systemic diseases of the study eyes at screening or baseline may cause participants to have no response to the study treatment or confuse the interpretation of the study results; 2. Study eye had uncontrollable glaucoma (defined as an intraocular pressure of >=25 mmHg after standardized treatment, or based on the investigator's judgment during the screening or baseline period); 3. Active intraocular or periocular infection or inflammation in either eye (such as conjunctivitis, keratitis, blepharitis, scleritis, uveitis, endophthalmitis, etc.); 4. History of idiopathic or autoimmune uveitis in either eye; 5. Severe turbidity of the refractive medium in the study eye or insufficient dilation of the pupil can affect BCVA or lead to the inability to obtain clear enough ocular imaging data, which affects the investigator's observation of safety and efficacy; 6. Study eye was an aphakic eyes with posterior capsule defect; 7. The non-study eye has severe visual dysfunction, including but not limited to BCVA160 mmHg or diastolic blood pressure >100 mmHg despite standard therapy); 19. Glycated hemoglobin (HbA1c) >10.0% within 28 days prior to participant screening; 20. Any of the following laboratory abnormalities: - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3.0 times the upper limit of normal (ULN), or total bilirubin (TBIL) > 2.0 times ULN - Glomerular Filtration Rate (GFR) < 30 ml/min/1.73 m² (using MDRD formula: GFR = 186 × serum creatinine (mg/dL) - 1.154 × (age) - 0.203 × (0.742 [if female]), with serum creatinine conversion: 1 µmol/L = 0.0113 mg/dL); 21. Received systemic anti-VEGF therapy within 90 days prior to baseline; 22. Received systemic anti-complement therapy within 90 days prior to baseline; 23. Any p
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; | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes in BCVA from baseline at each visit;Proportion of patients with BCVA improvement of >=0, >=5, >=10, and >=15 ETDRS letters from baseline at week 52;Proportion of participants with a decrease in BCVA of >0, >=5, >=10, and >=15 ETDRS letters from baseline at week 52;The change in central subfield thickness of the macula measured by OCT from the baseline at week 52;Proportion of participants with IRF/SRF/Pigment epithelial detachment (PED) on OCT at Week 52;Change in choroidal neovascularization (CNV) area on fundus fluorescein angiography (FFA) at week 52 compared to baseline;Change in CNV leakage area on FFA at week 52 compared to baseline;Change in total lesion area on FFA at week 52 compared to baseline;Proportion of participants with new-onset MA on OCT at Week 52;Proportion of new-onset fibrosis on color fundus photography (CFP) at Week 52;Change in MA area on OCT from baseline at Week 52;Change in fibrosis area and maximum lesion diameter on CFP from baseline at Week 52;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);The production of anti-drug antibodies in the serum; | — |
Countries
China
Contacts
Public ContactXiaodong Sun
Shanghai General Hospital
Outcome results
None listed