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New treatment option for Neovascular Age-related Macular Degeneration (AMD)
Official title Progression Suppression and Retinal Regression in VEGF-resistant AMD
ClinicalTrials.gov ID: NCT07005323
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 85
You may be able to join if
- Patients aged between 50 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 60 letters...
- 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...
- Patients who had little improvement in exudative changes and no improvement, or deterioration of vision in recent two treatment with VEGF inhibitor...
You likely can't join if
- Patients with fibrovascular pigment epithelial detachment (thickness 50 µm or more) in the subfoveal area in the subject eye.
- Patients with hard exudates in the subretinal or intraretinal area in the subject eye.
- Patients with eye infections
- Patients with a history of retinal vascular disease other than neovascular AMD, retinal degenerative disease, rhegmatogenous retinal detachment...
- 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...
See the full eligibility criteria
- Patients aged between 50 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 60 letters (equivalent to decimal vision of 0.32)
- 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...
- Patients who had little improvement in exudative changes and no improvement, or deterioration of vision in recent two treatment with VEGF inhibitor therapy (two consecutive administration at 4-8-week intervals), after...
- Patients with fibrovascular pigment epithelial detachment (thickness 50 µm or more) in the subfoveal area in the subject eye.
- Patients with hard exudates in the subretinal or intraretinal area in the subject 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...
- 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 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...
- Patients with corrected visual acuity of the non-subject eye 0.1 or less
- Patients who are currently receiving or will receive VEGF inhibitor treatment in the non-subject eye during the study period
- Patients with abnormal findings that pose a problem in clinical trial participation in screening tests.
- Patients with positive HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody, syphilis serum reaction
- Patients with allergies to human serum albumin antibiotics, trypsin
- Patients with severe blood disorders, heart failure, liver disorders, and renal disorders
- Patients diagnosed with malignant tumor within 5 years or patients requiring treatment
- Pregnant women, lactating women, patients wishing to become pregnant during the trial period
- Patients who cannot discontinue anticoagulants or antiplatelet drugs before the trial
- Patients with drug addiction or alcoholism
The study team makes the final eligibility decision.
Where it's taking place
- Ube, Ymaguchi, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ube, Ymaguchi, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.