A Phase II clinical trial to asses efficacy and safety of DARC methodology (Detection of Apoptosing Retinal Cells) in visualising the death of retinal cells in healthy volunteers and patients with Glaucoma, Age-Related Macular Degeneration, and Optic Neuritis.

A phase II, open label, non-randomised, single centre, clinical trial of ANX776 in Healthy Volunteers and patients with Glaucoma, Age-Related Macular Degeneration, and Optic Neuritis - A phase II clinical trial of DARC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002531-15-GB

Enrollment

100

Registered

2016-09-12

Start date

2016-11-14

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Age-related Macular Degeneration, and Optic Neuritis. MedDRA version: 19.0 Level: LLT Classification code 10047560 Term: Visual field perimetric tests System Organ Class: 10022891 - Investigations MedDRA version: 19.0 Level: HLGT Classification code 10018307 Term: Glaucoma and ocular hypertension System Organ Class: 10015919 -

Interventions

Product Name: ANX776 Pharmaceutical Form: Solution for injection INN or Proposed INN: Not assigned CAS Number: Not assigned Current Spon

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: General Inclusion Criteria are: 1. Age = 18 years 2. Clear optical media in the studied eye. 3. Refractive error not higher than spherical equivalent of 10 D and best corrected visual acuity equal to 6/24 or better at qualification. 4. Women of childbearing potential identified as not pregnant and have consented to complete a pregnancy test. 5. Subjects who have capacity to consent, and are willing to personally sign the informed consent document indicating that they have been informed of all pertinent aspects of the study. Group Specific Inclusion criteria are: Glaucoma: 1. Glaucoma group subjects will show progression in one or more of the parameters measured and will have at least one eye with a diagnosis of glaucoma (abnormal optic disc and/or visual field defect or both); be diagnosed as a glaucoma suspect or ocular hypertensive (elevated 10P). 2. Subjects proven to be able to perform reliable visual field testing using the HFA 640, central 24-2 program, to yield full thresholds, and have had good fundoscopy with assessment of their optic disc. Age-related Macular Degeneration: 1. Patients with AMD as defined by: 2. Early AMD mainly characterised by drusen, retinal pigment epithelium (RPE) pigment changes. 3. Late AMD mainly characterised as: geographic atrophy of the RPE (dry AMD). 4. Neovascular AMD (wet AMD). Optic Neuritis: 1. Clinical diagnosis of optic neuritis affecting one eye within two years. 2. Visual acuity in affected eye = 6/12 at worst point. 3. Corrected vision in unaffected eye = 6/6. 4. No history of optic neuritis or other ocular disease in either eye prior to the episode of optic neuritis. 5. Subjects proven to be able to perform reliable visual field testing using the HFA 640, central 24-2 program, to yield full thresholds, and have had good fundoscopy with assessment of their optic disc. Healthy Volunteers: 1. Confirmation of medical history as confirmed by General Practitioner. 2. No evidence of any eye disease Exploratory Optional fNIRS Inclusion Criteria: 1. Participants who are bald, or with short (less than 3cm), fair (unpigmented) hair Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: General Exclusion Criteria are: 1. Presence of severe, unstable or uncontrolled systemic disease. 2. Known intolerance to IMP. 3. Body weight 150kg. 4. Inability to comply with the study or follow-up procedures. 5. Any subjects with a known history of clotting diseases (including DVTs), and subjects taking anticoagulants. 6. Ocular surgery within the past 3 months or planned surgery in the study eye, during the course of the trial. 7. Pregnant, lactating, or premenopausal. 8. Currently being treated for cancer or any other disease likely to adversely affect participation in this study. 9. AIDS / HIV. 10. History of alcoholism or drug addiction. 11. History or active uveitis 12. History of systemic vasculitis, collagenosis or ongoing treatment of cancer. 13. Evidence of previous retinal vascular disease. 14. Individuals with terminal illness, or mental illness affecting their compliance with the study. 15. Central corneal thickness 650pm. 16. Currently, or within the last 3 months, enrolled in a clinical trial of an Investigational Medicinal Product. 17. History of retinal laser photocoagulation. 18. Media opacities or retinal pathology or amblyopia significantly limiting visual acuity, visual field test or retinal imaging. 19. Any other disease, condition or laboratory abnormality that in the opinion of the CI may increase the risk for the participation or may interfere with the interpretation of study results and in the judgement of the Investigator would make the subject inappropriate for entry into the study. Group Specific Exclusion criteria are: Glaucoma: 1. Uncontrolled I0P >24mmHg. 2. Angle closure/narrow glaucoma. Mean deviation at HVF >12dB. Age-related Macular Degeneration: 1. Presence of ocular conditions with increased risk of choroidal neovascularisation (CNVM). 2. Current or past use for more than 30 days of chloroquine, hydroxychloroquine, chlorpromazine, thioridazine, quinine sulfate, clofazimine, cisplatin, carmustine, (BCNU), deferoxamine, amiodarone, isoretinoin, or gold. Optic Neuritis: 1. Corticosteroid use in the past 2 months. Healthy Volunteers: 1. Evidence of any historical retinal eye disease. Exploratory Optional fNIRS Exclusion Criteria: 1. There are no specific exclusion criteria for the exploratory optional fNIRS.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: The secondary objective is to evaluate the response in terms of safety and tolerability of ANX776 in patients with Glaucoma, Age-related Macular Degeneration, Optic Neuritis, and in Healthy volunteers. Safety is defined as absence of an adverse event of grade 3 or above in the study groups. Safety will be measured by adverse events following the Common Terminology Criteria for Adverse Events (CTCAE) scale. In addition, in a subset of patients, an exploratory secondary objective is to assess if the ANX776 signal is detected in the brain using functional near-infrared spectroscopy (fNIRS). ; Primary end point(s): The primary outcome is the DARC Count in each eye 4 hours post injection. A log(x+1) transformation will be used for the statistical analysis. Geometric means and 95% confidence intervals will be used to summarise the log(x+1) DARC counts, back transformed to the original measurement scale. A regression model will be fitted to estimate the difference between each affected group and the healthy control group. The regression model will include patient as a random effect. ; Timepoint(s) of evaluation of this end point: During injection 15 min post injection 2 hours post injection 4 hours post injection Retinal imaging will be utilised to visualise apoptosing retinal ganglion cells at above time intervals; corresponding DARC counts inclusive of their means and standard deviations will be reported. ; Main Objective: The primary outcome is the efficacy of the intervention ascertained by the DARC Count, which is the number of apoptosing retinal cells visualised 4 hours after the ANX776 injection in patients with Glaucoma, Age-related Macular Degeneration, Optic Neuritis and in Healthy volunteers.	—

Measure

Time frame

Secondary Objective: The secondary objective is to evaluate the response in terms of safety and tolerability of ANX776 in patients with Glaucoma, Age-related Macular Degeneration, Optic Neuritis, and in Healthy volunteers. Safety is defined as absence of an adverse event of grade 3 or above in the study groups. Safety will be measured by adverse events following the Common Terminology Criteria for Adverse Events (CTCAE) scale. In addition, in a subset of patients, an exploratory secondary objective is to assess if the ANX776 signal is detected in the brain using functional near-infrared spectroscopy (fNIRS). ; Primary end point(s): The primary outcome is the DARC Count in each eye 4 hours post injection. A log(x+1) transformation will be used for the statistical analysis. Geometric means and 95% confidence intervals will be used to summarise the log(x+1) DARC counts, back transformed to the original measurement scale. A regression model will be fitted to estimate the difference between each affected group and the healthy control group. The regression model will include patient as a random effect. ; Timepoint(s) of evaluation of this end point: During injection 15 min post injection 2 hours post injection 4 hours post injection Retinal imaging will be utilised to visualise apoptosing retinal ganglion cells at above time intervals; corresponding DARC counts inclusive of their means and standard deviations will be reported. ; Main Objective: The primary outcome is the efficacy of the intervention ascertained by the DARC Count, which is the number of apoptosing retinal cells visualised 4 hours after the ANX776 injection in patients with Glaucoma, Age-related Macular Degeneration, Optic Neuritis and in Healthy volunteers.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary outcome is the number and severity of adverse events. The overall number of adverse events will be reported, stratified by patient group, and categorised according to their nature and severity. For the Near-infrared spectroscopy, the outcome measure will be the detection of the NIR fluorescent signal in the brain. ; Timepoint(s) of evaluation of this end point: During injection 15 min post injection 2 hours post injection 4 hours post injection 30 days post injection - safety telephone call (adverse events only).	—

Measure

Time frame

Secondary end point(s): Secondary outcome is the number and severity of adverse events. The overall number of adverse events will be reported, stratified by patient group, and categorised according to their nature and severity. For the Near-infrared spectroscopy, the outcome measure will be the detection of the NIR fluorescent signal in the brain. ; Timepoint(s) of evaluation of this end point: During injection 15 min post injection 2 hours post injection 4 hours post injection 30 days post injection - safety telephone call (adverse events only).

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026