Condition category
Eye Diseases
Date applied
22/09/2006
Date assigned
24/10/2006
Last edited
03/08/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M Francesca Cordeiro

ORCID ID

Contact details

Institute of Ophthalmology
UCL
11-43 Bath Street
London
EC1V 9EL
United Kingdom

Additional identifiers

EudraCT number

2006-005273-22

ClinicalTrials.gov number

Protocol/serial number

DARC1

Study information

Scientific title

Assessment of Detection of Apoptosing Retinal Cells in glaucoma

Acronym

DARC in glaucoma

Study hypothesis

Detection of Apoptosing Retinal Cells (DARC) is a new imaging technique that may be used to identify and monitor early retinal neurodegeneration in glaucoma.

Updated 03/08/2015:
This trial did not go ahead in the format described in ISRCTN59484478. Following the review of the IMP pre-clinical data by the MHRA scientific advisory group, the design of the trial needed to change significantly. These significant changes in design made this a new trial. It was decided that the new trial would be registered with the trial sponsors' account on another registered public clinical trial database.

Ethics approval

Local and national ethics application currently under review

Study design

3 stages:
1. Cross-sectional pilot study to evaluate DARC counts
2. Prospective investigator masked randomised active placebo-controlled pilot
3. Longitudinal pilot study to correlate DARC counts

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Glaucoma

Intervention

In the treatment part of the study looking at the effect of brimonidine on glaucoma in patients with progressing disease, patients will be randomised to treatment with brimonidine or placebo. This group of patients will already be on at least first-line anti-glaucoma Intra-Ocular Pressure (IOP) lowering treatment so that addition of brimonidine as an additional treatment would be normal clinical practice. The placebo group of progressing patients will obviously not be getting this additional treatment, but this group is important to include if we are to accurately assess brimonidine efficacy. All patients in the treatment arm of the study will be regularly assessed for IOP control – hence any patient shown to have inadequate control of IOP will be withdrawn from the study, so that appropriate treatment can be instigated. In other words, any patient on placebo with inadequate IOP control will be withdrawn from the study.

Eligible subjects in the treatment groups (i.e., progressing and non progressing) will be randomised in a 1:1 ratio to receive either a fixed or non-fixed formulation containing brimonidine twice a day or placebo twice a day. IOP will be checked at baseline, and after 4 weeks, 3, 6, 12 and 18 months of treatment. Dosing will be at 9 am and 9 pm. All patients will already be on treatment (except brimonidine) for IOP.

All study medication will be supplied in identical SSP oval bottles filled to a volume of 5 ml with either Alphagan/Combigan or placebo. Bottles will be supplied in individual boxes by Allergan Pharmaceuticals. Subjects will be instructed to store opened bottles of study medication in the boxes. To minimise potential bias towards the outcome of the study by subjects, investigators and study personnel regarding the safety, efficacy and comfort of the test articles, the study will be investigator masked. Subjects will be randomised to receive either Alphagan/Combigan or Placebo in a 1:1 ratio. The investigator or study staff will enrol qualified subjects into the study in a sequential manner by subject number, beginning with the first number in a numerical series assigned by the CRO. The randomisation list will be kept in the pharmacy and the subject will collect medication, labelled A or B or C, from the pharmacy and be dispensed the medication according to the study number from the randomisation list.

There are three stages:

Stage 1: a cross-sectional pilot study to evaluate DARC counts in age-matched groups of 'normals' to non-progressing and progressing glaucoma patients, and ocular hypertensive and normal tension glaucoma patients.

Stage 2: a prospective investigator masked randomised active placebo-controlled pilot study comparing age-matched groups of 'normals' to non-progressing and progressing glaucoma patients to establish baseline DARC counts before and after treatment with brimonidine or brimonidine-containing formulation.

Stage 3: a longitudinal pilot study to correlate DARC counts to visual field assessment and analysis of optic disc cupping in age-matched groups of 'normals' and ocular hypertensive and normal tension glaucoma patients.

Intervention type

Drug

Phase

Not Applicable

Drug names

Brimonidine

Primary outcome measures

The primary outcome measure is the DARC count

Secondary outcome measures

The secondary measures are the visual field and optic disc assessment

Overall trial start date

01/12/2006

Overall trial end date

31/08/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Our patient group will be identified from the glaucoma clinics at The Western Eye Hospital according to the following inclusion criteria:
1. For all patient groups:
1.1. Aged 18 years or over
1.2. Clear optical media in the studied eye
1.3. Previous experience at automated perimetry
1.4. No ocular or systemic disease (other than glaucoma in the test group)
1.5. Refractive error not higher than spherical equivalent of 6 D
1.6. Best corrected visual acuity equal to 6/9 or better
2. All subjects will have to have been shown to be able to perform reliable visual field testing using the HFA 640 instrument, central 24-2 program, to yield full thresholds (Deviation, MD-HFA and Pattern Standard Deviation, PSD-HFA), and have had good fundoscopy with assessment of their optic disc
3. Subjects willing and able to make the required study visits
4. All subjects must be able to understand the information describing the study and give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

98

Participant exclusion criteria

1. History of current or severe, unstable or uncontrolled cardiovascular, hepatic or renal disease (e.g., sinus bradycardia, cardiac failure) precluding safe administration of a topical beta antagonists
2. History of bronchial asthma or chronic obstructive airways disease precluding use of a topical beta antagonist
3. Women of childbearing age will be excluded from the study unless they have been surgically sterilised
4. Contact lens wearers will not be allowed to participate in the study
5. Previous ocular surgery such as retinal detachment, multiple surgical procedures including glaucoma
6. Co-existing disease which may affect DARC count e.g., retinal vein occlusion, age-related macular degeneration (AMD)

Recruitment start date

01/12/2006

Recruitment end date

31/08/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Ophthalmology,
London
EC1V 9EL
United Kingdom

Sponsor information

Organisation

St Mary's Hospital NHS Trust (UK)

Sponsor details

The Western Eye Hospital
Marylebone Road
London
NW1 5YE
United Kingdom

Sponsor type

Government

Website

http://www.st-marys.nhs.uk/index.html

Funders

Funder type

Charity

Funder name

Unrestricted educational grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes