Study to Assess Safety and Tolerability of PMC-403 in Subjects With Neovascular Age-related Macul… (NCT05953012) | Clinical Trial Compass
CompletedPhase 1
Study to Assess Safety and Tolerability of PMC-403 in Subjects With Neovascular Age-related Macular Degeneration
South Korea17 participantsStarted 2023-07-20
Plain-language summary
This is a Phase 1 study, first-in-human (FIH), open label study to evaluate the safety, tolerability and identify the maximum tolerated dose (MTD) of PMC-403 and determine the recommended phase 2 dose (RP2D).
Who can participate
Age range50 Years
SexALL
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Inclusion criteria
✓. The eye with lower (severer) best corrected visual acuity (BCVA) at baseline will be selected as the study eye.
✓. If both eyes have the same BCVA, the right eye will be selected as the study.
✓. Male and female ≥50 years of age at the time of written informed consent.
✓. Treatment required, based on the judgment of the investigator, due to insufficient therapeutic efficacy despite ≥ 3 repeated doses of anti-vascular endothelial growth factor (anti-VEGF) intravitreal injection (IVT) for nAMD in the study eye, and the subject's agreement to receive the study drug instead of conventional standard therapy
✓. \>12 weeks must have elapsed since the last dose of anti-VEGF IVT at the time of screening.
✓. Active subfoveal or parafoveal choroidal neovascularization (CNV)\* confirmed by fundus fluorescein angiography (FFA), spectral domain-optical coherence tomography (SD-OCT), and IndoCyanine Green (ICG) angiography.
✓. The size of the entire lesion in the study eye (including blood, atrophy, fibrosis, and neovascularization) must be ≤ 9-disc areas, and the area of CNV in the study eye must account for ≥ 50% of the total area of the lesion, as confirmed by FFA and ICG angiography.
✓. BCVA measured in the study eye must be between ≥ 23 letters and ≤ 78 letters based on the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart (Snellen visual acuity 20/25 - 20/320).
. Uncontrolled ocular hypertension (≥ 25 mmHg) despite drug therapy;
✕. Retinal pigment epithelium (RPE) tears involving the macula;
✕. Improvement in visual acuity is not expected due to scars, fibrosis, or atrophy involving the fovea;
✕. Presence of vitreous hemorrhage;
✕. Aphakia or absence of posterior capsule (with the exception of pseudophakic eyes treated with laser posterior capsulotomy);
✕. Presence of any causes of CNV other than nAMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streak, choroidal rupture, or uveitis; or
✕. Macular pathology that is unrelated to nAMD, but may affect visual acuity or study drug treatment (e.g., macular hole, epiretinal membrane, vitreomacular traction, macular telangiectasia, central serous chorioretinopathy, retinal vascular occlusion, etc.).