This study aims to preliminarily evaluate the efficacy and safety of GB10 intravitreal (IVT) injection for the treatment of patients with neovascular age-related macular degeneration (nAMD). It consists of two parts, single-ascending-dose escalation (SAD) and multiple-ascending-dose escalation (MAD).
In SAD, a single IVT of up to 6 doses will be administered to up to 36 treatment-naïve or previously treated patients with nAMD. If the lowest dose is considered safe without dose-limiting toxicity, escalation will proceed to the next higher dose level. At the end of SAD, the two doses that best balance efficacy and safety will be selected and entered into MAD.
In MAD, a single IVT of 2 doses will be administered to 12 treatment-naïve or previously treated patients with nAMD, who will be enrolled across the low- to high-dose levels.
After GB10 intervention, the participants will undergo tests to evaluate the PK/PD characteristics of GB10 and ocular and non-ocular safety.
Diagnosed with choroidal neovascularization (CNV) secondary to AMD (nAMD); For the study eye, either no prior IVT anti-VEGF treatment (treatment-naïve patients) or the last injection of the prior IVT anti-VEGF treatment occurred > 3 months before the first dose, with investigator-assessed effectiveness of prior anti-VEGF therapy (previously treated patients).
The study eye must have either subfoveal CNV or juxtafoveal CNV with a subfoveal component related to the CNV activity (as evidenced by subretinal fluid, subretinal hyper-reflective material, leakage, or hemorrhage);
Total lesion size (including blood, atrophy, fibrosis, and neovascularization) of ≤ 9 disc areas by FFA;
CNV component area of ≥ 50% of total lesion size by FFA;
CNV in the study eye due to causes other than AMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis;
Subretinal hemorrhage of > 50% of the total lesion area and/or that involves the fovea; or
Fibrosis or atrophy of > 50% of the total lesion area and/or that involves the fovea;
Any concurrent intraocular condition in the study eye (e.g., central serous chorioretinopathy [CSC], retinal pigment epithelial tear involving the macula, amblyopia, aphakia, retinal detachment, cataract, diabetic retinopathy or maculopathy, epiretinal membrane with traction, retinal vein occlusion, etc.) that, in the opinion of the investigator, may either reduce the potential for visual improvement or require medical or surgical intervention;
Sequential
GB10
DrugGB10 Intravitreal Injection with indicating dosage.
8
Treatment groupsSee each treatment group below.
The incidence and severity of ocular adverse events
The incidence and severity of non-ocular adverse events
(SAD) The change in best corrected visual acuity (BCVA) from baseline after 4 weeks of treatment
(MAD) The change in best corrected visual acuity (BCVA) from baseline after 12 weeks of treatment
(SAD) Change in central retinal subfield thickness (CST) from baseline at 4 weeks of treatment
(MAD) Change in central retinal subfield thickness (CST) from baseline at 12 weeks of treatment
Time of receiving rescue therapy for nAMD activity
Positive rate of anti-drug antibody and neutralizing antibody of GB10
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