ASP7317 for Age-Related Macular Degeneration

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Age-Related Macular DegenerationASP7317 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is for adults 50+ who are losing their vision due to dry age-related macular degeneration. A new treatment, ASP7317, which is a specially created type of cell derived from human stem cells, will be injected into the macula of the eye in an effort to slow or reverse atrophy.

Eligible Conditions
  • Age-Related Macular Degeneration

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 4 Secondary · Reporting Duration: Baseline, Weeks 1, 4, 6, 8, 12, 16, 26 and 52/End of Study (EOS)

Week 1
Mean change from baseline in best corrected visual acuity (BCVA) score in study eye and fellow eye
Week 26
Mean change from baseline in area of Geographic Atrophy (GA) (mm^2) in study eye and fellow eye
Mean change from baseline in the square root transformation of Geographic Atrophy (GA) area in study eye and fellow eye
Mean percent change from baseline in area of Geographic Atrophy (GA) (mm^2) in study eye and fellow eye
Up to 52 Weeks
Incidence of cellular graft failure or rejection
Number of participants with cellular graft failure or rejection
Safety as assessed by incidence, frequency and severity of Serious Adverse Events (SAEs)
Safety as assessed by incidence, frequency and severity of treatment emergent adverse events (TEAES)
Safety assessed by Adverse Events (AEs) of special interest

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

ASP7317 Dose Escalation (Group 2)
1 of 2
ASP7317 Dose Escalation (Group 1)
1 of 2

Experimental Treatment

18 Total Participants · 2 Treatment Groups

Primary Treatment: ASP7317 · No Placebo Group · Phase 1

ASP7317 Dose Escalation (Group 2)Experimental Group · 2 Interventions: ASP7317, tacrolimus · Intervention Types: Drug, Drug
ASP7317 Dose Escalation (Group 1)Experimental Group · 2 Interventions: ASP7317, tacrolimus · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tacrolimus
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, weeks 1, 4, 6, 8, 12, 16, 26 and 52/end of study (eos)

Who is running the clinical trial?

Astellas Institute for Regenerative MedicineLead Sponsor
8 Previous Clinical Trials
110 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Institute for Regenerative Medicine
2,638 Previous Clinical Trials
7,941,959 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The participant is able and willing to attend all scheduled visits and assessments up to the week 52 visit.
People who take antidepressants must be on a stable and effective dosage, and must be willing to take it reliably for as long as it is required.
The person undergoing the surgery must be willing to have monitored anesthesia care and must be medically suitable for it.
The person agrees not to take part in any other studies during the 52 week visit.
A female participant must not donate eggs starting at the first dose of the study drug and throughout the study period and for 52 weeks after taking the study drug.
Participants must be willing to take tacrolimus and be willing to stop taking any medications that have a known interaction with tacrolimus.
A woman who agrees to follow the contraceptive guidance from the time of informed consent through at least 52 weeks after investigational product (IP) administration is a WOCBP.
The female participant must agree not to breastfeed starting at screening and throughout the study period and for 52 weeks after receiving the IP.
The general inclusion criteria are met.

Who else is applying?

What state do they live in?
Florida33.3%
Alabama33.3%
Mississippi16.7%
Other16.7%
How old are they?
65+75.0%
18 - 6525.0%
What site did they apply to?
Retina Specialty Institute66.7%
Emory University Eye Center33.3%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%

How responsive is this trial?

Typically responds via
Email100.0%
Most responsive sites:
  1. Emory University Eye Center: < 48 hours
Average response time
  • < 2 Days