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A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration

RecruitingPhase 1Ages 50 Years - anyAllAstellas Institute for Regenerative Medicine
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In plain words

What the trial is, and whether it could suit you

Age-related macular degeneration (AMD) is an eye disease which causes people to lose their sharp central vision over time. Aging damages the macula, which is in the middle of the retina - the light-sensitive part at the back of the eye. There are 2 types of AMD - wet AMD and dry AMD. The advanced stage of dry AMD causes vision loss. This is known as geographic atrophy. AMD makes everyday tasks like reading or driving difficult. ASP7317 is a potential new treatment for people with AMD. ASP7317 are human stem cells which have changed into cells found in the retina. ASP7317 is injected under the macula. It is hoped that ASP7317 will replace some of the damaged cells in the macula and improve vision for people with dry AMD. Before ASP7317 is available as a treatment, the researchers need to check its safety and how well it is tolerated. They will also check for signs of improved vision. Pe

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: General Inclusion Criteria * Participant must be willing to take tacrolimus and willing to discontinue any medications that have a known strong interaction with tacrolimus. * Participant is able and willing to undertake all scheduled visits and assessments up to the week 52 visit. * Participant who is taking an antidepressant must be on a stable and effective dosage and must be willing to take it reliably for as long as it is required. * Participant must be willing and medically suitable to undergo monitored anesthesia care during the vitrectomy and subretinal injection. * Participant agrees to conform to local and institutional policies regarding active COVID-19 infections. * Participant agrees not to participate in another interventional study until the 52-week visit has been completed. * Female participant is not pregnant or at least 1 of the following conditions apply: * Not a woman of childbearing potential (WOCBP) * WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 52 weeks after investigational product (IP) administration. * Female participant must agree not to breastfeed starting at screening and throughout the study period and for 52 weeks after IP administration. * Female participant must not donate ova starting at first dose of IP and throughout the study period and for 52 weeks after IP administration. * Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 52 weeks after IP administration. * Male participant must not donate sperm during the treatment period and for 52 weeks after IP administration. * Male participant with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 52 weeks after IP administration. Ocular Inclusion Criteria: Study Eye (Both Groups 1 and 2) * Participant has bilateral AMD and geographic atrophy (GA) secondary to Age-Related Macular Degeneration (AMD) in the study eye. GA is defined as sharply demarcated areas of loss of the retinal pigment epithelial/epithelium (RPE). While having bilateral GA remains the preferred enrollment criterion, it is not a requirement and GA only in the study eye is admissible, as long as both eyes exhibit AMD. * Participant has no known history of choroidal neovascularization (CNV) (wet AMD) in either eye prior to enrollment in the trial and no evidence of prior or active CNV with optical coherence tomographyangiography (OCT-A) or indocyanine green angiography (ICG-A), as assessed by the reading center. * Participant has absence of exudation as assessed by fluorescein angiography (FA) and spectral domain-optical coherence tomography (SD-OCT). * Participant has sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging. * Participant is pseudophakic. Ocular Inclusion Criteria: Study Eye (Group 1 only) * For cohort 1, the participant has a BCVA between light perception and \</=23 Early Treatment Diabetic Retinopathy study (ETDRS) letters at the screening visit. For cohorts 2 and 3, the participant has a BCVA score between 15 (\>/= 20/500) and 37 (\</=20/200) ETDRS letters at the screening visit. * Participant has the total GA area \</=30.5 mm\^2 (\</=12 disc areas \[DA\]). Ocular Inclusion Criteria: Study Eye (Group 2 only) * Participant has BCVA score between 38 (\>20/200) and 65 (\</=20/50) ETDRS letters during the screening visit. * Participant has the total GA area of \>/= 2.54 mm\^2 and \</= 20.4 mm\^2 (\>/=1 and \</=8 DA, respectively) and must reside completely within the fundus autofluorescence (FAF) imaging field (Field 2 to 30 degree image centered on the fovea). * Participant has a difference in mean mesopic sensitivity \</=2 dB between 2 tests at screening. If not \</=2 dB, a third test may be conducted and mean values between the second and third assessments must be \</=2 dB. Exclusion Criteria: General Exclusion Criteria * Participant has a history of recurrent varicella zoster virus (VZV) infection or a clinical diagnosis of VZV infection within 4 weeks of the baseline visit or positive anti-VZV immunoglobulin M (IgM). Being positive for immunoglobulin G (IgG), indicative of a past infection (or vaccination), is not an exclusionary criterion. * Participant has a history of recurrent cytomegalovirus (CMV) infection or a clinical diagnosis of CMV infection within 4 weeks of the baseline visit or positive anti-CMV IgM. Being positive for IgG, indicative of a past infection, is not an exclusionary criterion. * Participant has a positive tuberculosis (TB) test during the screening period by an interferon gamma release assay (e.g., QuantiFERON) within the 6 months prior to the screening. If a participant has tested negative for TB within the 6 months prior to the screening visit, retesting is not required unless clinically indicated. * Participant has a history or suspected active infection of toxoplasmosis or presence of elevated immunoglobulin M (IgM) toxoplasmosis titer within 4 weeks of the baseline visit. * Participant has an active infection (ocular or non-ocular) requiring the prolonged or chronic use of antimicrobial or anti-infective agents. * Participant has a current malignancy or history of malignancy within the past 5 years, except non-metastatic basal or squamous cell carcinoma or keratoacanthoma or Bowen's disease or carcinoma-in-situ of the cervix that has been successfully treated. * Participant has a history of a solid organ or bone marrow transplant. * Participant has any condition that would prohibit the use of systemic immunosuppression with tacrolimus. * Participant is receiving or has received any immunosuppressive therapy (IMT) (other than topical, inhaled or low dose systemic corticosteroid use not exceeding 7.5 mg of prednisone daily \[or equivalent\]) wit
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What it tests

  • ASP7317
  • tacrolimus
  • trimethoprim-sulfamethoxazole
  • Acyclovir
  • Nystatin
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Where

20 sites
Retinal Consultants of Arizona LTD, Retinal Research Institute
Phoenix, United States
Jules Stein Eye Institute
Los Angeles, United States
Stanford University Byers Eye Institute
Palo Alto, United States
Kaiser Permanente Riverside Medical Center
Riverside, United States
Retina Consultants of Southwest Florida & National Ophthalmic Research Institute
Fort Myers, United States
Retina Specialty Institute
Pensacola, United States
Emory University Eye Center
Atlanta, United States
University Retina and Macula Associates
Oak Forest, United States

โ€ฆand 12 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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