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 (NCT03178149)
A Phase 1b, Multicenter, Dose Escalation, Evaluation of Safety and Tolerability of ASP7317 for Geographic Atrophy Secondary to Age-related Macular Degeneration
🩺 Plain-English Summary (8th-Grade Level)
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. People taking part in this study will be older people who have geographic atrophy caused by dry AMD. This is an open-label study. This means that people in this study and clinic staff will know that people will receive ASP7317. There will be 3 doses of ASP7317. These are low, medium and high numbers of cells. ASP7317 will be injected under the macula after the person is given either a local or a general anesthetic. To prevent the body from rejecting the cells, people will take tablets of tacrolimus a few days before receiving ASP7317 for up to a few weeks afterwards. Other medicines will be taken during this time to stop infections. There will be 2 groups in the study. Group 1 will be people with severe vision loss and Group 2 will be people with moderate vision loss. There will be different small groups of people within Group 1 and Group 2, with each small group receiving 1 of the 3 doses of ASP7317. Different small groups of people within Group 1 and Group 2 will receive lower to higher doses of ASP7317. Each small group will only receive 1 dose. Group 1 will start treatment first. At each dose, a medical expert panel will check the results of the first person in the group to decide if the rest of the group will receive the same dose. Then, the panel will decide if more people may receive the same dose or if the next group may receive the next highest dose. The panel will use the results from the lower dose of Group 1 to decide when Group 2 starts treatment (also at the lower dose). The panel will also use the results of the middle and higher doses in Group 1 to decide when and how many people in Group 2 can receive these doses. During the study, people will visit the clinic several times for up to 12 months (1 year). During all visits, the study doctors will check for any medical problems after receiving ASP7317. Vital signs will be checked a few days before treatment with ASP7317 and up to about a month afterwards. Vital signs include blood pressure, pulse, and temperature. At some visits, the study doctors will also take blood samples for blood tests. At most visits, people will have eye tests and have different images, scans, and measurements taken. This could be for the affected eye or both eyes, depending on the test. People can visit the clinic extra times, if needed.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (25 items) and avoid the listed exclusions (44 items).
Location: Retinal Consultants of Arizona LTD, Retinal Research Institute — Phoenix, Arizona
Age range: 50 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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 \[or equivalent\]) within 6 weeks or 5 plasma half-lives, whichever is longer, prior to the administration of adjunct study medications.
- Participant has a history of myocardial infarction in previous 12 months and whose disease is either unstable and/or symptomatic (e.g., angina, dyspnea, etc.).
- Participant has electrocardiogram (ECG) results that are clinically significant and could either jeopardize the safety of the participant, impact the participant's ability to comply with study visit schedule or impact the validity of the study results. Participants with a mean Fridericia-corrected QT interval of \> 430 ms (for males) and \> 450 ms (for females) at screening must be cleared by a cardiologist prior to the baseline visit.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (19 Sites)
- Retinal Consultants of Arizona LTD, Retinal Research Institute — Phoenix, Arizona
- Jules Stein Eye Institute — Los Angeles, California
- Stanford University Byers Eye Institute — Palo Alto, California
- Kaiser Permanente Riverside Medical Center — Riverside, California
- Retina Consultants of Southwest Florida & National Ophthalmic Research Institute — Fort Myers, Florida
- Retina Specialty Institute — Pensacola, Florida
- Emory University Eye Center — Atlanta, Georgia
- University Retina and Macula Associates — Oak Forest, Illinois
- Mass Eye and Ear Infirmary Ophthalmology Clinical Research Office — Boston, Massachusetts
- Ophthalmic Consultants of Boston — Boston, Massachusetts
- University of Michigan Kellog Eye Center — Ann Arbor, Michigan
- Deep Blue Retina — Southaven, Mississippi
- NJ Retina — New Brunswick, New Jersey
- Mid-Atlantic Retina — Philadelphia, Pennsylvania
- Tennessee Retina, PC — Nashville, Tennessee
- Retina Foundation of the Southwest — Dallas, Texas
- Valley Retina Institute — McAllen, Texas
- University of Washington — Seattle, Washington
- Spokane Eye Clinical Research — Spokane, Washington
📞 Contact the Study Coordinator
Phone: (800) 888-7704
Email: astellas.registration@astellas.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Age-Related Macular Degeneration
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- Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration — Poway, California
- National Eye Institute Biorepository for Retinal Diseases — Bethesda, Maryland
- A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders — Springfield, Illinois
- Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration — San Francisco, California
- Effects of Goji vs. Fiber on Macular Degeneration — Sacramento, California
Explore by condition: All Age-Related Macular Degeneration clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.