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RECRUITING
NCT03178149
PHASE1

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

Sponsor: Astellas Institute for Regenerative Medicine

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 1b, Multicenter, Dose Escalation, Evaluation of Safety and Tolerability of ASP7317 for Geographic Atrophy Secondary to Age-related Macular Degeneration

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2018-07-13

Completion Date

2026-06-30

Last Updated

2026-01-13

Healthy Volunteers

No

Interventions

DRUG

ASP7317

subretinal injection

DRUG

tacrolimus

oral

DRUG

trimethoprim-sulfamethoxazole

oral

DRUG

Acyclovir

oral

DRUG

Nystatin

oral

Locations (19)

Retinal Consultants of Arizona LTD, Retinal Research Institute

Phoenix, Arizona, United States

Jules Stein Eye Institute

Los Angeles, California, United States

Stanford University Byers Eye Institute

Palo Alto, California, United States

Kaiser Permanente Riverside Medical Center

Riverside, California, United States

Retina Consultants of Southwest Florida & National Ophthalmic Research Institute

Fort Myers, Florida, United States

Retina Specialty Institute

Pensacola, Florida, United States

Emory University Eye Center

Atlanta, Georgia, United States

University Retina and Macula Associates

Oak Forest, Illinois, United States

Mass Eye and Ear Infirmary Ophthalmology Clinical Research Office

Boston, Massachusetts, United States

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

University of Michigan Kellog Eye Center

Ann Arbor, Michigan, United States

Deep Blue Retina

Southaven, Mississippi, United States

NJ Retina

New Brunswick, New Jersey, United States

Mid-Atlantic Retina

Philadelphia, Pennsylvania, United States

Tennessee Retina, PC

Nashville, Tennessee, United States

Retina Foundation of the Southwest

Dallas, Texas, United States

Valley Retina Institute

McAllen, Texas, United States

University of Washington

Seattle, Washington, United States

Spokane Eye Clinical Research

Spokane, Washington, United States