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.

Phase 1

• 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 - Eye disorders; MedDRA version: 19.0 Level: LLT Classification code 10021948 Term: Infiltration intravenous injection System Organ Class: 100000004867; MedDRA version: 19.0 Level: PT Classification code 10057208 Term: Optical coherence tomography System Organ Class: 10022891 - Investigations; MedDRA version: 19.0 Level: PT Classification code 10071129 Term: Neovascular age-related macular degeneration System Organ Class: 10015919 - Eye disorders; MedDRA version: 19.0 Level: PT Classification code 10064930 Term: Age-related macular degeneration System Organ Class: 10015919 - Eye disorders; MedDRA version: 19.0 Level: PT Classification code 10047566 Term: Visual field tests System Organ Class: 10022891 - Investigations; MedDRA version: 19.0 Level: LLT Classification code 10009034 Term: Chronic open angle glaucoma System Organ Class: 10015919 - Eye disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2016-002531-15-GB
• Lead Sponsor: CL Comprehensive Clinical Trials Unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-12
• Study Completion: 2018-06-07
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 113

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

General Exclusion Criteria are:
1.Presence of severe, unstable or uncontrolled systemic disease.
2.Known intolerance to IMP.
3.Body weight <40kg or >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 <450 pm or >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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified