Progression Suppression and Retinal Regression in VEGF-resistant AMD

Korábbi kezelés

• Patients who have undergone intraocular surgery in the subject eye. (In the case of cataract surgery, patients may be enrolled if they have had no endophthalmitis or other complications, have progressed well, and more than 7 days have passed since the surgery)
• Patients who cannot discontinue anticoagulant or antiplatelet let drugs within the appropriate timeframe specified by the principal investigator or a sub-investigator
• Patients with drug addiction or alcoholism

Más betegség

• Patients with subretinal hemorrhage (1 disc diameter or greater) or hemorrhagic pigment epithelial detachment (of any size) in the study eye.
• Patients with eye infections
• Patients with a history of retinal vascular disease other than neovascular AMD, retinal degenerative disease, rhegmatogenous retinal detachment, macular hole, premacular membrane with retinal wall, uveitis, or other ocular inflammatory disease in the subject eye.
• Patients with severe blood disorders, heart failure, liver disorders, and renal disorders
• Patients diagnosed with malignant tumor within 5 years or patients requiring treatment

Laborértékek

• Patients with positive HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody, syphilis serum reaction
• Patients with allergies to human serum albumin antibiotics, trypsin

Egyéb

• Patients with fibrovascular pigment epithelial detachment (thickness 150 micrometer or more) in the subject eye.
• Patients with hard exudates in the subretinal or intraretinal area in the subject eye.
• Patients in whom polypoid lesions are observed in the subject eye on fundus examination, OCT, fluorescein angiography, etc.
• Patients with optic nerve atrophy in the subject eye
• Patients with progressive glaucoma in the subject eye (in whom intraocular pressure is not controlled, or visual field loss is progressive or has already spread to the macula)
• Patients with severe myopia in the subject eye (axial length of 26.5 mm or more, or spherical equivalent of -7.0 D or less in phakic eyes)
• Patients with corrected visual acuity of the non-subject eye 0.1 or less
• (Missing number)
• Patients with abnormal findings that pose a problem in clinical trial participation in screening tests.
• Pregnant women, lactating women, patients wishing to become pregnant during the trial period

• Patients aged between 18 and 85 years at the time of consent acquisition
• Patients diagnosed neovascular AMD in one or both eyes
• Patients with corrected letter vision in the subject eye of 20 letters or more (equivalent to decimal vision of 0.05) and less than 70 letters (equivalent to decimal vision of 0.5)
• Patients who apply to one or more of the followings:
  • ① RPE defect site in the RPE tear includes the Fovea
  • ② The Macular atrophy confirmed by low fundus autofluorescence extends to the fovea
  • ③ Patients with choroidal thinning (200 micrometer and less), and subretinal fluid resistant to standard treatment
  • ④ Patients with cystoid macular degeneration with photoreceptor cell loss and intraretinal fluid above fibrovascular pigment epithelial detachment
• Patients who had little improvement in exudative changes, with persistent exudative changes to date, and no improvement, or deterioration of vision in two treatments with VEGF inhibitor therapy (two consecutive administration at intervals of 11 weeks +/- 3 days or less within the past year), after existing therapy