A Phase 1/2 interventional study of ASP2767 and Sham ASP2767 in Glaucoma, sponsored by Astellas Pharma Global Development, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Astellas Pharma Global Development, Inc. (part of Astellas Pharma Inc) · Phase 1/2, Interventional, and Treatment
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.
1,419 studies on the registry are indexed under Glaucoma; 223 are open to participants now.
This study's planned enrollment of 156 is above the median of 61 across 964 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Astellas Pharma Global Development, Inc. is the lead sponsor of 207 studies on the registry; 23 are open to participants now.
Of its 82 completed or terminated interventional studies of FDA-regulated products, 38 (46%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participant has open-angle glaucoma (OAG) defined as rate of MD ≤ -0.5 dB/year and consisting of all of the following:
Female participant is not pregnant and at least 1 of the following conditions apply:
Exclusion Criteria:
Participant has history of
Participant has any of the following medical conditions
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a single dose of ASP2767 by intravitreal (IVT) injection into the study eye on Day 1 and protocol-defined prophylactic regimen.
Drug: ASP2767 · Drug: Prophylactic Regimen A
Participants will receive a single dose of ASP2767 by IVT injection into the study eye on Day 1 and protocol-defined prophylactic regimen.
Drug: ASP2767 · Drug: Prophylactic Regimen B
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
Drug: ASP2767 · Drug: Prophylactic Regimen A · Drug: Prophylactic Regimen B
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
Drug: ASP2767 · Drug: Prophylactic Regimen A · Drug: Prophylactic Regimen B
Participants will receive a single sham injection on Day 1 and a placebo prophylactic regimen
Drug: Sham ASP2767 · Drug: Placebo for prophylactic regimen
IVT Injection
Mimic IVT injection using empty syringe
Protocol defined
Protocol defined
Protocol defined
Phase 1: Number of participants experiencing dose limiting toxicities (DLTs)
DLT is defined as any adverse event which meets DLT criteria that occurs during the DLT observation period unless it is attributed by the investigator to another clearly identifiable cause (e.g. concomitant medications/procedures or pre-existing medical or ocular conditions for additional context).
Time frame: Up to 4 weeks
Phase 1: Number of participants with treatment emergent adverse events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of study intervention This includes events related to the comparator, if applicable, and events related to the (study) procedures. TEAE is defined as an AE with onset or worsening in severity on or after the date of administration of ASP2767 or sham procedure and up to the end of the follow-up period.
Time frame: Up to 52 weeks
Phase 1: Number of participants with serious adverse events (SAEs)
An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defects and other medically important situations.
Time frame: Up to 52 weeks
Phase 1: Number of participants with adverse events of special interest (AESIs)
AESIs are the predefined AEs which are closely monitored throughout the study.
Time frame: Up to 52 weeks
Phase 1: Number of participants with ophthalmic examination abnormalities and or/AEs
Number of participants with ophthalmic examination abnormalities and or/AEs will be reported.
Time frame: Up to 52 Weeks
Phase 1: Number of participants with ophthalmic imaging abnormalities and or/AEs
Number of participants with ophthalmic imaging abnormalities and or/AEs will be reported.
Time frame: Up to 52 Weeks
Phase 1: Number of participants with vital signs abnormalities and/or AEs
Number of participants with vital signs abnormalities and/or AEs will be reported.
Time frame: Up to 52 weeks
Phase 1: Number of participants with laboratory value abnormalities and/or AEs
Number of participants with laboratory value abnormalities and/or AEs will be reported.
Time frame: Up to 52 weeks
Phase 1: Change from baseline in best-corrected visual acuity (BCVA)
BCVA will be measured from the ETDRS letters chart.
Time frame: Baseline and up to Week 52
Phase 2: Mean rate of change (slope) from baseline in visual field (VF) (24-2) mean deviation (MD)
VF examination will be assessed using standard automated perimetry.
Time frame: Baseline and Week 52
Phase 1: Number of participants with positive anti-adeno-associated virus serotype (AAV) antibodies
Serum samples will be collected for testing the presence of Anti-AAV antibodies.
Time frame: Up to Week 52
Phase 1: Number of participants with positive anti-transgene antibodies
Serum samples will be collected for testing the presence of Anti-transgene antibodies.
Time frame: Up to Week 52
Phase 1: Number of participants with positive AAV interferon gamma (IFN-γ) enzyme-linked immunosorbent spot assay (ELISpot)
Serum samples will be collected, together with blood samples for isolation of peripheral blood mononuclear cells (PBMCs) for IFN-γ ELISpot assays.
Time frame: Up to Week 52
Phase 2: Mean rate of change (slope) from baseline in VF (10-2) MD
VF examination will be assessed using standard automated perimetry.
Time frame: Baseline and Week 52
Phase 2: Percentage of participants with ≥ 7 dB change in 5 VF points from baseline
VF examination will be assessed using standard automated perimetry.
Time frame: Baseline and Week 52
Phase 2: Number of participants with TEAEs
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures. TEAE is defined as an AE with onset or worsening in severity on or after the date of administration of ASP2767 or sham procedure and up to the end of the follow-up period.
Time frame: Up to week 52
Phase 2: Number of participants with SAEs
An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defects and other medically important situations.
Time frame: Up to week 52
Phase 2: Number of participants with AESIs
AESIs are the predefined AEs which are closely monitored throughout the study.
Time frame: Up to week 52
Phase 2: Change from baseline in macular thickness: ganglion cell complex (GCC)
Global and sectoral macular thickness of GCC will be measured using the SD-OCT.
Time frame: Baseline, Week 24 and 52
Phase 2: Change from baseline in peripapillary retinal nerve fiber layer (RNFL) thickness
Global and sectoral thickness of peripapillary RNFL will be measured using the SD-OCT.
Time frame: Baseline, Week 24 and 52
Phase 2: Change from baseline in quantitative contrast sensitivity measurement - area under the log contrast sensitivity function (AULCSF)
AULCSF will be assessed using the manifold platform.
Time frame: Baseline, Week 24 and 52
Phase 2: Change from baseline in quantitative contrast sensitivity measurement - contrast acuity
Contrast acuity will be assessed using the manifold platform.
Time frame: Baseline, Week 24 and 52
Phase 2: Change from baseline in quantitative contrast sensitivity measurement - photopic contrast sensitivity
Photopic contrast sensitivity will be assessed using the manifold platform.
Time frame: Baseline, Week 24 and 52
Phase 2: Change from baseline in quantitative contrast sensitivity measurements - mesopic contrast sensitivity
Mesopic contrast sensitivity will be assessed using the manifold platform.
Time frame: Baseline, Week 24 and 52
Phase 2: Change from Baseline in BCVA
BCVA will be measured from the ETDRS letters chart.
Time frame: Baseline, Week 24 and 52
Phase 2: Number of Participants with Positive Anti-AAV antibodies
Serum samples will be collected for testing the presence of Anti-AAV antibodies.
Time frame: Up to Week 52
Phase 2: Number of Participants with Positive Anti-transgene antibodies
Serum samples will be collected for testing the presence of Anti-transgene antibodies.
Time frame: Up to Week 52
Phase 2: Number of participants with Positive AAV IFN-γ ELISpot
Serum samples will be collected, together with blood samples for isolation of PBMCs for IFN-γ ELISpot assays.
Time frame: Up to Week 52
Phase 2: Change from baseline in macular thickness: ganglion cell/inner plexiform layer (GCIPL)
Global and sectoral macular thickness of GCIPL will be measured using the SD-OCT.
Time frame: Baseline, Week 24 and 52
Phase 2: Change from baseline in macular thickness: ganglion cell layer (GCL)
Global and sectoral macular thickness of GCL will be measured using the SD-OCT.
Time frame: Baseline, Week 24 and 52
Phase 2: Change from baseline in macular thickness: inner plexiform layer (IPL)
Global and sectoral macular thickness of IPL will be measured using the SD-OCT.
Time frame: Baseline, Week 24 and 52
Plan to share: Yes — Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Data sharing details ↗ · www.clinicaltrials.astellas.com
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Jul 2030, 45 months after the start.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Oct 2026, on Oct 22, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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