A Study About the Safety of ASP2767 and Whether it Helps People With Glaucoma-Related Optic Nerve Damage

Sponsor
Astellas Pharma Global Development, Inc.
Study ID
NCT07770685
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ASP2767 — DRUG
    IVT Injection
  • Sham ASP2767 — DRUG
    Mimic IVT injection using empty syringe
  • Prophylactic Regimen A — DRUG
    Protocol defined
  • Prophylactic Regimen B — DRUG
    Protocol defined
  • Placebo for prophylactic regimen — DRUG
    Protocol defined

Study Details

Open-angle glaucoma is the most common type of glaucoma, a disease that damages the nerves in the eye and can lead to vision loss. Current treatments include eye drops, laser treatment, and surgery that help lower eye pressure. However, they do not work for everyone, and the disease may continue to worsen over time. Researchers are looking for better ways to treat open-angle glaucoma. This is an early development study of ASP2767 in people with open-angle glaucoma. In this study, ASP2767 will be given to humans for the first time. ASP2767 is a type of treatment called gene therapy. Gene therapy uses a tool called a vector. In this study a harmless virus is used as the vector. The vector delivers genes into specific parts of the body like the eyes. Once in the eyes these genes help nerve cells in the retina make proteins. These proteins are designed to protect the nerves in the eyes and may help slow down or prevent vision loss. The main aims of the study are to check the safety of ASP2767 in people with open-angle glaucoma, how well they tolerate it, and to find the highest dose of ASP2767 people can safely receive. In addition, the study will also look at the effect of ASP2767 on vision in people with open-angle glaucoma. The study has 2 phases. In both phases of the study, ASP2767 will be given as a single injection into one eye only. In phase 1, small groups of people with open-angle glaucoma will receive ASP2767 starting with lower doses and increasing to higher doses in later groups. The people in the study will also receive prophylactic medicines which will help reduce the risk of inflammation after receiving the ASP2767 injection. Phase 1 is an open-label study. This means that people in the study and the researchers will know which treatment people are getting. Any medical problems people have at each dose level in this study will be recorded. This will help find the highest dose of ASP2767 that people can safely receive, which will also be used in phase 2. In phase 2, another larger group of people with open-angle glaucoma will be randomly placed in 1 of 3 groups of equal size. This means each person will have an equal chance of being placed in any of the 3 groups. They will receive either the highest dose of ASP2767 that people safely received in phase 1, or a slightly lower dose of ASP2767, or a sham injection. A sham injection is a procedure that mimics the injection but does not deliver ASP2767 into the eye. To reduce the risk of inflammation due to the injection, people in the study will also receive a prophylactic medicine or placebo depending on the group they are in. The placebo will look like the prophylactic medicine and will be given in a similar way but will not have any active medicine in it. Researchers use sham injections and placebo to make sure any effect they see in people who take ASP2767 is actually caused by the drug. Phase 2 is a double-masked study, meaning neither the people in the study, nor the researchers will know who is given which treatment. All the people in phase 1 and phase 2 will be followed up for about 1 year after receiving the treatment. After receiving their ASP2767 injection, people will visit the clinic on certain days to have health checks. They will also have their vision checked using different eye tests and will give regular blood and urine samples.

Key Dates

First listed
Aug 18, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Jul 31, 2030
Completion
Jul 31, 2030

Study Design

Enrollment
156 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1: ASP2767 Dose Escalation + Prophylactic Regimen A
    Participants will receive a single dose of ASP2767 by intravitreal (IVT) injection into the study eye on Day 1 and protocol-defined prophylactic regimen.
  • Experimental: Phase 1: ASP2767 Dose Escalation + Prophylactic Regimen B
    Participants will receive a single dose of ASP2767 by IVT injection into the study eye on Day 1 and protocol-defined prophylactic regimen.
  • Experimental: Phase 2: ASP2767 High Dose - Dose Expansion + Prophylactic Regimen
    Participants will receive a single high dose of ASP2767 by IVT injection into the study eye on Day 1 and a prophylactic regimen based on data from Phase 1
  • Experimental: Phase 2: ASP2767 Low Dose - Dose Expansion + Prophylactic Regimen
    Participants will receive a single low dose of ASP2767 by IVT injection into the study eye on Day 1 and a prophylactic regimen based on data from Phase 1
  • Sham Comparator: Phase 2: Sham ASP2767 + Placebo Prophylactic Regimen
    Participants will receive a single sham injection on Day 1 and a placebo prophylactic regimen

Primary Outcome Measure

Phase 1: Number of participants experiencing dose limiting toxicities (DLTs) [ Time Frame: Up to 4 weeks ]

Central Contacts

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