Neovascular Age-related Macular Degeneration (AMD)
Conditions
Brief summary
The goal of this clinical trial is to assess safety and efficacy in patients with Neovascular Age-related Macular Degeneration with no response to existing therapy. The main measures it aims to answer are: * Investigation of adverse events * Changes in clinical testing data * Changes in vital signs * Changes in intraocular pressure of the therapeutic eye * Changes in testing of anterior segment of the therapeutic eye Participants will be implanted one sheet of PAL-222 into the subretinal space through pars plana vitrectomy. Researchers will compare pre and post implantation of therapeutic eye to see if any safety issues recognized
Interventions
PROCEDUREPars plana vitrectomy
One sheet of PAL-222 is implanted into the subretinal space of either of eyes through pars plana vitrectomy.
Sponsors
PharmaBio Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged between 18 and 85 years at the time of consent acquisition 2. Patients diagnosed neovascular AMD in one or both eyes 3. 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) 4. 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 5. 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
Exclusion criteria
1. Patients with fibrovascular pigment epithelial detachment (thickness 150 micrometer or more) in the subject eye. 2. Patients with hard exudates in the subretinal or intraretinal area in the subject eye. 3. Patients in whom polypoid lesions are observed in the subject eye on fundus examination, OCT, fluorescein angiography, etc. 4. Patients with subretinal hemorrhage (1 disc diameter or greater) or hemorrhagic pigment epithelial detachment (of any size) in the study eye. 5. Patients with eye infections 6. 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. 7. Patients with optic nerve atrophy in the subject eye 8. 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) 9. 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) 10. 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) 11. Patients with corrected visual acuity of the non-subject eye 0.1 or less 12. (Missing number) 13. Patients with abnormal findings that pose a problem in clinical trial participation in screening tests. 14. Patients with positive HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody, syphilis serum reaction 15. Patients with allergies to human serum albumin antibiotics, trypsin 16. Patients with severe blood disorders, heart failure, liver disorders, and renal disorders 17. Patients diagnosed with malignant tumor within 5 years or patients requiring treatment 18. Pregnant women, lactating women, patients wishing to become pregnant during the trial period 19. Patients who cannot discontinue anticoagulant or antiplatelet let drugs within the appropriate timeframe specified by the principal investigator or a sub-investigator 20. Patients with drug addiction or alcoholism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Evaluation: Incidence, type, and severity of Adverse Events (AE) | 52 weeks |
Countries
Japan
Contacts
CONTACTHitoshi Kusano, M.D.
STUDY_CHAIRHitoshi Kusano, M.D.
PhamaBio Coorporation
Outcome results
None listed