GlaucomaPhase 1NCT02394613
A Phase I Clinical Trial of DARC
A Phase 1 study testing ANX776 in people with Glaucoma and Ocular Hypertension, run by University College, London at 1 site in United Kingdom.
Trial summary
Glaucoma is a major cause of irreversible blindness worldwide, caused by retinal nerve cell (RGC) death. This is currently identified only after significant vision loss has already occurred with an early event in, and a potential marker of, this process being RGC "apoptosis" (a form of cell death). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Ocular Hypertension, Glaucoma, Suspect
- What is being tested?
- ANX776
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2015to Aug 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 18 years
- Clear optical media in the studied eye
- No ocular or systemic disease (except glaucoma in the test group)
- Refractive error not higher than spherical equivalent of 6D; best corrected visual acuity ≥ 6/24 at qualification
- Proven ability to perform reliable visual field testing (HFA 640, central 24-2 program) to yield full thresholds, and have had good fundoscopy with assessment of the optic disc
- Willing and able to comply with the scheduled visits and assessments. Informed Consent Form personally (or by legal representative) signed and dated
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- Women Not of Childbearing Potential (postmenopausal or permanently sterilised)
- Male participants agree to double barrier contraception from consent until 6 weeks after treatment discontinuation
- GLAUCOMA patients
- Show progression in any measured parameter; have at least one eye with a diagnosis of glaucoma (abnormal optic disc, visual field defect or both); be diagnosed as a glaucoma suspect or ocular hypertensive (elevated Intraocular Pressure (IOP))
- NORMAL subjects
- No evidence of any glaucomatous process (either optic disc, Retinal Nerve Fibre Layer (RNFL) of visual field abnormalities with normal IOPs)
- Must provide a GP letter confirming their medical history
- GLAUCOMA \& NORMAL patients • Have performed at least 3 Visual Field tests, Heidelberg Retinal Tomography (HRT), and Optical Coherence Tomography (OCT) before or during Visit-1
- POSITIVE CONTROL patients
- Diagnosis of acute unilateral NAION in the first eye within 15 days of onset of symptoms
- Snellen test (or equivalent) Visual acuity below 6/12 in the affected eye
- Visual field defect and relative afferent pupillary defect (RAPD)
- Normal motility of the pupillary sphincter muscle
- Normal macula
- Completion of 1 Visual field test, OCT and HRT examination at Visit-1
Who cannot join
- Terminal or mental illness, dementia, inability to comply with the study or follow-up procedures
- Presence of ocular or systemic uncontrolled disease (unless deemed not clinically significant by Chief Investigator and Sponsor), except glaucoma in the test group
- Central corneal thickness <450µm or >650µm
- History of current or severe, unstable or uncontrolled systemic disease (unless deemed not clinically significant by Chief Investigator and Sponsor)
- Body weight <40kg or >120kg
- Evidence of another chronic neurodegenerative condition
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- Patients with active antiphospholipid syndrome or with diagnosis of circulating antiphospholipid antibodies
- History of clotting diseases (including Deep Vein Thromboses), subjects taking anticoagulants
- Diagnosis of thrombocytopenia, heart valve disease, and livedo reticularis
- Pregnancy or lactation
- Allergy to any study medication ingredient
- Inclusion in a clinical trial of an IMP within 12 weeks prior to study entry
- Ocular surgery within the past 3 months in the study eye
- History of retinal laser photocoagulation
- Media opacities or retinal pathology or amblyopia significantly limiting visual acuity, visual field test or retinal imaging
- Expected need for ocular surgery during the study
- Severe or acute or chronic medical or psychiatric condition or laboratory abnormality that, in the opinion of the Chief Investigator, makes the subject inappropriate for the study
- GLAUCOMA patients
- Uncontrolled IOP >24 mmHg
- Angle closure/narrow glaucoma
- Mean deviation at Humphrey Visual Field (HVF) >12dB
- Unilateral glaucoma
- Secondary glaucoma
- NORMAL subjects
- History of systemic vasculitis, collagenosis or ongoing treatment of cancer
- Active uveitis
- Evidence of previous retinal vascular disease
- NORMAL \& POSITIVE CONTROL subjects
- History or evidence of glaucoma (fundoscopy and Visual Field) or clinical suspicion of glaucoma on presentation or IOP ≥ 24 mmHg in either eye at any time
- POSITIVE CONTROL patients
- Any other aetiology to explain optic nerve disease
- Evidence of giant cell arteritis (history, sedimentation rate)
- Evidence for other optic neuropathy (even fellow eye) or multiple sclerosis (history, clinical examination)
- History of other optic neuropathies
- History of NAION in the same eye
- Active/recurrent ocular inflammation that may prevent retinal imaging
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Western Eye Hospital, Imperial College Healthcare NHS Trust,
London, NW1 5QH
About this study
Official title: A Phase I, Storer Design, Open-label, Cross-sectional, Single Site Trial of ANX776 in Healthy Volunteers, Progressive Glaucoma/Glaucoma-suspect/Ocular Hypertensive Subjects and Non-arteritic Anterior Ischaemic Optic Neuropathy Subjects
Glaucoma is a major cause of irreversible blindness worldwide, caused by retinal nerve cell (RGC) death. This is currently identified only after significant vision loss has already occurred with an early event in, and a potential marker of, this process being RGC "apoptosis" (a form of cell death).
This study aims to investigate the tolerability and safety of ANX776, as part of the new Detection of Apoptosing Retinal Cells (DARC) technique. This has been developed by the laboratory of DARC IP holder and grant applicant: Prof. M. Francesca Cordeiro. A secondary aim is to initially establish the ability of DARC to identify RGC apoptosis in the diagnosis of glaucoma in healthy and progressive glaucoma/glaucoma-suspect/ocular hypertensive patients. As a positive control for this secondary aim of this study, patients with Non-arteritic Anterior Ischaemic Optic Neuropathy (NAION) will be recruited.
Read more
During the study, each patient will undergo several ophthalmological examinations, imaging of the back of the eye using established clinical devices, and blood sampling for studying the safety and toxicology profile of ANX776.
The understanding of the safety profile of ANX776 is crucial for the use of DARC in patients, and its application as a potentially powerful new clinical tool with which to identify patients with early glaucoma before their vision is lost. If successful, it opens the door to directly observing effects of glaucoma treatments, including the assessment of new, breakthrough therapies.
- Conditions
- Glaucoma, Ocular Hypertension, Glaucoma, Suspect
- Being tested
- ANX776
- Keywords
- Glaucoma, DARC, Diagnosis
- Medical subject headings
- Glaucoma, Ocular Hypertension, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANX776Drug
Single intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| ANX776 | Experimental | Using and increasing dose storer design, GLAUCOMA and NORMAL patients will be randomly grouped to received the intervention (0.1 mg, 0.2 mg, 0.4 mg, 0.5 mg). 1 NAION patient will receive each dose once it has been proven safe in GLAUCOMA and NORMAL patients, as part of the secondary objective of this trial. Receives: Drug: ANX776 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of ANX776 as defined by the number and nature of adverse events
Serious and adverse medical events will be recorded
Measured: 24 hours
Secondary outcomes (1)
DARC Count
Confocal Laser-Scanning Ophthalmoscopy (cSLO) imaging will be used to ascertain the number of apoptosing retinal cells in each of the study populations.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2015
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust
- Responsible party
- Sponsor
- Investigators
- Philip Bloom, MB ChB FRCS, Principal investigator, Western Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394613
- Sponsor's protocol ID
- 08/0351
- Other IDs
- 2014-002504-25, 2014
- Status last verified
- Aug 2015
- First submitted
- 4 Mar 2015
- Last updated
- 26 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Storer Design, Open-label, Cross-sectional, Single Site Trial of ANX776 in Healthy Volunteers, Progressive Glaucoma/Glaucoma-suspect/Ocular Hypertensive Subjects and Non-arteritic Anterior Ischaemic Optic Neuropathy Subjects
- ClinicalTrials.gov ID
- NCT02394613
- Acronym / sponsor ID
- 08/0351
- Conditions
- Glaucoma, Ocular Hypertension, Glaucoma, Suspect
- Keywords
- Glaucoma, DARC, Diagnosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Wellcome Trust
- Study start
- May 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Aug 2016 (estimated)
- First posted
- 20 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Glaucoma is a major cause of irreversible blindness worldwide, caused by retinal nerve cell (RGC) death. This is currently identified only after significant vision loss has already occurred with an early event in, and a potential marker of, this process being RGC "apoptosis" (a form of cell death).
This study aims to investigate the tolerability and safety of ANX776, as part of the new Detection of Apoptosing Retinal Cells (DARC) technique. This has been developed by the laboratory of DARC IP holder and grant applicant: Prof. M. Francesca Cordeiro. A secondary aim is to initially establish the ability of DARC to identify RGC apoptosis in the diagnosis of glaucoma in healthy and progressive glaucoma/glaucoma-suspect/ocular hypertensive patients. As a positive control for this secondary aim of this study, patients with Non-arteritic Anterior Ischaemic Optic Neuropathy (NAION) will be recruited.
During the study, each patient will undergo several ophthalmological examinations, imaging of the back of the eye using established clinical devices, and blood sampling for studying the safety and toxicology profile of ANX776.
The understanding of the safety profile of ANX776 is crucial for the use of DARC in patients, and its application as a potentially powerful new clinical tool with which to identify patients with early glaucoma before their vision is lost. If successful, it opens the door to directly observing effects of glaucoma treatments, including the assessment of new, breakthrough therapies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ANX776 | Experimental | Drug: ANX776Using and increasing dose storer design, GLAUCOMA and NORMAL patients will be randomly grouped to received the intervention (0.1 mg, 0.2 mg, 0.4 mg, 0.5 mg). 1 NAION patient will receive each dose once it has been proven safe in GLAUCOMA and NORMAL patients, as part of the secondary objective of this trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- ≥ 18 years
- Clear optical media in the studied eye
- No ocular or systemic disease (except glaucoma in the test group)
- Refractive error not higher than spherical equivalent of 6D; best corrected visual acuity ≥ 6/24 at qualification
- Proven ability to perform reliable visual field testing (HFA 640, central 24-2 program) to yield full thresholds, and have had good fundoscopy with assessment of the optic disc
Key exclusion criteria (36 listed)
- Terminal or mental illness, dementia, inability to comply with the study or follow-up procedures
- Presence of ocular or systemic uncontrolled disease (unless deemed not clinically significant by Chief Investigator and Sponsor), except glaucoma in the test group
- Central corneal thickness <450µm or >650µm
- History of current or severe, unstable or uncontrolled systemic disease (unless deemed not clinically significant by Chief Investigator and Sponsor)
- Body weight <40kg or >120kg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANX776Single intravenous injection | Drug | ANX776 |
Primary outcome
Safety of ANX776 as defined by the number and nature of adverse events
Time frame: 24 hours
Serious and adverse medical events will be recorded
1 secondary outcome
DARC Count
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Bloom, MB ChB FRCS principal investigator
Western Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ANX776 in people with Glaucoma and Ocular Hypertension, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of ANX776 as defined by the number and nature of adverse events (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2016.