Actively Recruiting
A Phase 1b, Multicenter, Dose Escalation Study of Safety and Tolerability of ASP7317 for Geographic Atrophy Secondary to Age-related Macular Degeneration
Led by Astellas Institute for Regenerative Medicine · Updated on 2026-01-13
42
Participants Needed
19
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Age-related macular degeneration (AMD) is an eye condition that causes gradual loss of sharp central vision, making activities like reading or driving difficult. This study focuses on people with geographic atrophy, the advanced stage of dry AMD, where damaged cells in the eye lead to vision loss. Researchers are evaluating ASP7317, a treatment made from human stem cells designed to replace damaged retinal cells and potentially improve vision. This Phase 1b study aims to assess the safety and tolerability of ASP7317 in senior adults with this condition. Participants receive ASP7317 through an injection under the macula after anesthesia, with three different dosage levels: low, medium, and high. To reduce the risk of rejection, participants take tacrolimus and other medications before and after the injection to prevent infection. The study has two groups based on vision severity—severe and moderate vision loss—with small subgroups receiving escalating doses. A medical panel reviews safety data after each dose before continuing or increasing the dose. Treatment and follow-up visits occur over 52 weeks. During the study, participants attend multiple clinic visits for eye exams, imaging, scans, and blood tests to monitor safety, vision changes, and any side effects. Vital signs such as blood pressure, pulse, and temperature are checked before and after treatment. Researchers track adverse events, graft rejection, and changes in vision and retinal health at set intervals up to one year. Participants may also have additional visits if needed for extra monitoring or care.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 50 years or older
- Willing to take tacrolimus and discontinue medications that strongly interact with tacrolimus
- Able and willing to attend all scheduled visits and assessments up to 52 weeks
- Stable dosage if taking antidepressants and willing to continue reliably
- Medically suitable for anesthesia during vitrectomy and subretinal injection
- Agree to local COVID-19 policies
- Agree not to join another interventional study until after 52 weeks
- Female participants must not be pregnant or must follow contraceptive guidance if of childbearing potential
- Female participants must not breastfeed during screening and for 52 weeks after treatment
- Female participants must not donate ova during treatment and for 52 weeks after
- Male participants with female partners of childbearing potential must use contraception during treatment and for 52 weeks after
- Male participants must not donate sperm during treatment and for 52 weeks after
- Male participants with pregnant partners must abstain or use condoms during partner's pregnancy and for 52 weeks after
- Have bilateral AMD with geographic atrophy or GA in the study eye and AMD in both eyes
- No history or evidence of wet AMD or choroidal neovascularization
- No exudation in eye exams
- Clear ocular media, adequate pupil dilation, and fixation for imaging
- Pseudophakic
- For severe vision loss group: BCVA between light perception and 23 ETDRS letters or 15 to 37 ETDRS letters depending on cohort
- Total GA area less than or equal to 30.5 mm²
- For moderate vision loss group: BCVA between 38 and 65 ETDRS letters
- Total GA area between 2.54 mm² and 20.4 mm² within imaging field
- Stable mean mesopic sensitivity between tests
You will not qualify if you...
- History of recurrent or recent varicella zoster or cytomegalovirus infection
- Positive tuberculosis test within 6 months
- History or suspicion of active toxoplasmosis infection
- Active infection requiring prolonged antimicrobial treatment
- Current or recent malignancy except certain skin or cervical cancers
- History of solid organ or bone marrow transplant
- Conditions prohibiting systemic immunosuppression with tacrolimus
- Recent immunosuppressive therapy other than low dose corticosteroids
- Recent unstable or symptomatic myocardial infarction
- Clinically significant ECG abnormalities without cardiologist clearance
- High diastolic blood pressure above 95 mmHg
- Low kidney function (eGFR ≤ 30 mL/min)
- Elevated liver enzymes or bilirubin (≥ 2 times upper limit)
- Severe anemia, low white blood cells, low platelets, or high hematocrit
- Hemoglobin A1c above 8.5%
- Significant blood clotting disorders
- Positive tests for syphilis, Lyme disease, HIV, or active hepatitis infections
- History of familial adenomatous polyposis or inflammatory bowel disease
- Allergic reactions to mydriatics or fluorescein
- Previous gene or cell therapy including ASP7316
- Participation in other investigational drug or procedure studies within 12 weeks
- Recent use of complement inhibitors in study eye within 24 weeks
- Unwillingness to discontinue certain interacting medications during tacrolimus use
- Positive drug abuse urine screen unless medically supervised
- Macular degeneration from other causes
- Presence of wet AMD or CNV in either eye
- Foveal sparing with intact photoreceptors near foveal center
- History of vitrectomy, submacular surgery, or AMD-related surgeries
- Prior photodynamic therapy, radiation, or thermotherapy
- Previous laser treatment for certain eye conditions
- Vitreoretinal interface abnormalities affecting measurements
- History of various retinal diseases or lesions
- Active or past intraocular inflammation
- Ocular toxoplasmosis scars
- Certain pigmented choroidal lesions or nevi
- Pathologic myopia or related macular degeneration
- Uncontrolled glaucoma or glaucoma surgery history
- History of corneal transplantation
- Monocular vision or no light perception in fellow eye
- Contraindications to pupil dilation
- Other ocular conditions interfering with imaging assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 8 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks post treatment
Participants receive escalating doses of ASP7317 through subretinal injection, along with oral tacrolimus and other medicines to prevent infection. Treatment occurs in successive cohorts with safety reviews before dose escalation.
Multiple visits for dosing and safety assessments over 52 weeks
Trial Site Locations
Total: 19 locations
1
Retinal Consultants of Arizona LTD, Retinal Research Institute
Phoenix, Arizona, United States, 85053
Withdrawn
2
Jules Stein Eye Institute
Los Angeles, California, United States, 90095
Actively Recruiting
3
Stanford University Byers Eye Institute
Palo Alto, California, United States, 94303
Actively Recruiting
4
Kaiser Permanente Riverside Medical Center
Riverside, California, United States, 92505
Actively Recruiting
5
Retina Consultants of Southwest Florida & National Ophthalmic Research Institute
Fort Myers, Florida, United States, 33912
Withdrawn
6
Retina Specialty Institute
Pensacola, Florida, United States, 35203
Actively Recruiting
7
Emory University Eye Center
Atlanta, Georgia, United States, 30322
Actively Recruiting
8
University Retina and Macula Associates
Oak Forest, Illinois, United States, 60452
Actively Recruiting
9
Mass Eye and Ear Infirmary Ophthalmology Clinical Research Office
Boston, Massachusetts, United States, 02114
Withdrawn
10
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
Actively Recruiting
11
University of Michigan Kellog Eye Center
Ann Arbor, Michigan, United States, 48105
Actively Recruiting
12
Deep Blue Retina
Southaven, Mississippi, United States, 38671
Actively Recruiting
13
NJ Retina
New Brunswick, New Jersey, United States, 08901
Withdrawn
14
Mid-Atlantic Retina
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
15
Tennessee Retina, PC
Nashville, Tennessee, United States, 37203
Withdrawn
16
Retina Foundation of the Southwest
Dallas, Texas, United States, 75231
Actively Recruiting
17
Valley Retina Institute
McAllen, Texas, United States, 78503
Completed
18
University of Washington
Seattle, Washington, United States, 98104
Withdrawn
19
Spokane Eye Clinical Research
Spokane, Washington, United States, 99204
Actively Recruiting
Research Team
A
Astellas Institute for Regenerative Medicine
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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