Condition category
Eye Diseases
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Diabetic retinopathy is the most common cause of sight loss in people of working age. Sight loss occurs in diabetes because of diabetic macular oedema (DMO) and/or proliferative diabetic retinopathy (PDR) - both are complications of diabetes in the eye. In DMO, fluid accumulates in the macula, the area responsible for our central sight. As the fluid accumulates, the sight drops. The current treatments for DMO include laser and “anti-VEGF” drugs (VEFF stands for vascular endothelial growth factor). Anti-VEGF drugs have been very helpful in the treatment of DMO. However, they need to be given by an injection into the eye. An ophthalmologist (eye specialist) or a specialist nurse (a nurse trained for this purpose) needs to treat patients with DMO in the hospital. Patients require injections every four weeks during the first months of treatment and long term treatment is required. Not all patients respond to anti-VEGFs: in 40 - 50% of patients the sight does not improve despite these injections. Because many patients with DMO have DMO in both eyes, injections need to be given in both eyes to many patients.
There is a clear need to develop new treatments for people with DMO. ARA 290 is a drug that has anti-inflammatory properties and has an effect in preventing the death of cells. As inflammation is known to play a role in the occurrence of DMO, ARA 290 could potentially be helpful in treating patients with this condition. The aim of the study is to find out if ARA 290 helps drying the fluid in DMO.

Who can participate?
Adult patients with diabetic retinopathy and centre involving DMO with central retinal thickness of > 400 microns.

What does the study involve?
Participants will have to a subcutaneous injection of 4mg of ARA290 at home for a period of 12 weeks. Ie they will give themselves an injection under the skin in the left or right thigh. If they are unable to inject into either thigh, they can inject under the skin of the abdomen.They will be monitored with a follow up visit every four weeks until the end of the treatment and will undergo a series of tests at the beginning, during and at the end of the treatment.

What are the possible benefits and risks of participating?
This is an initial study and a larger one will be required to provide confirmation.
If this treatment is successful, the health service may benefit from a reduction of the demands on health care services and patients may benefit from the following: one injection given can treat both eyes at once ; reduced risks associated with injections; the injection is administered subcutaneously (under the skin) rather than in the eye which may be a more pleasant treatment. These potential benefits would last only whilst participants are in the study. ARA290 is a relatively new drug. The most common side effect observed after its administration has been headaches. A fluorescein test is carried out before and after the treatment period. For this test, the dye (fluorescein) is injected into a vein in the arm from where it will travel to the eye. Photographs are taken as the dye goes through the blood vessels in the eye, which allows us to determine whether the blood vessels in the eye are less “leaky” after the treatment and whether there is good circulation of blood through the retina. This dye test is often done in people with diabetic retinopathy and DMO; the risks associated with it are mild (mild: nausea may occur in 7 out of 100 patients and vomiting in 1 out of 100 patients; moderate: a skin rash may occur in 1 out of 100 patients) or rare (bronchospasm and laryngeal oedema which can be treated successfully).

Where is the study run from?
Belfast Health & Social Care Trust, Northern Ireland (UK)

When is the study starting and how long is it expected to run for?
May 2015 to May 2016

Who is funding the study?
This is an investigator led study funded by Araim Pharmaceuticals Ltd (UK).

Who is the main contact?
Ms Jacqueline Boyd-McConville

Trial website

Contact information



Primary contact

Ms Jacqueline Boyd-McConville


Contact details

Centre for Experimental Medicine
Institute of Clinical Science Block A
Queen's University Belfast
Grosvenor Road
BT12 6BA
United Kingdom
+44 (0)28 9063 2135



Additional contact

Prof Noemi Lois


Contact details

Centre for Experimental Medicine
Institute of Clinical Science Block A
Queen's University Belfast
Grosvenor Road
BT12 6BA
United Kingdom
+44 (0)28 9063 3325

Additional identifiers

EudraCT number

2015-001940-12 number

Protocol/serial number


Study information

Scientific title

A phase II Clinical Trial on the use of ARA 290 for the treatment of Diabetic Macular Oedema



Study hypothesis

The hypothesis tested is that ARA 290, when administered subcutaneously at 4mg on a daily basis for 12 weeks, due to its anti-inflammatory, anti-apoptotic and neuroprotective effects, will be of therapeutic value in patients with diabetes mellitus and diabetic macular oedema.

Ethics approval

1. REC Committee for England, Wales and Northern Ireland: South Central –Berkshire Research Ethics Committee, 14/03/2016, REC Ref: 16/SC/0089
2. REC Committee for Scotland: Scotland A Research Ethics Committee, 23/03/2016, REC Ref: 16/SS/0048

Study design

Prospective open label interventional single centre investigator-led phase II study

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet: ARA 290-DMO Trial Manager, NICTU, 1st Floor, Elliott Dynes Centre, Royal Hospitals, Grosvenor Road, Belfast, BT12 6BA


Diabetic macular oedema (DMO)


The patient will be required to self administer a subcutaneous injection of ARA 290 in their own home, at a dose of 4 mg daily for a period of 12 weeks. The patient will be monitored carefully with a follow up visit every four weeks until the end of the 12 week trial treatment. If the patient responds to the treatment and the retina is seen to be dried at the 12 week visit, the treatment will stop and a further visit will be arranged at week 16 to see whether the effect of the treatment lasts even when the treatment has been stopped.

Dosing regime: Weeks 1 - 12. 4 mg ARA 290 injected subcutaneously on a daily basis.

Baseline: Medical history; vital signs; ETDRS BCVA; Schirmer test; SD-OCT; Wide angle fundus photographs and fluorescein angiography (FFA); Microperimetry; Bloods; Urine collection; C-SSRS; EQ-5D-5L; NEI VFQ-25.
Weeks 4 & 8 (+/-7days): Vital signs; ETDRS BCVA; SD-OCT; Record of adverse events; C-SSRS.
Week 12 (+/-7days): vital signs; ETDRS BCVA; Schirmer test; SD-OCT; Wide angle fundus photographs and fluorescein angiography (FFA); Microperimetry; Record of AEs; Bloods; Urine collection; C-SSRS; EQ-5D-5L; NEI VFQ-25.
Week 16 (if applicable): vital signs; ETDRS BCVA; Schirmer test; SD-OCT; Microperimetry; Bloods; Urine collection; C-SSRS; EQ-5D-5L; NEI VFQ-25.

Intervention type



Phase II

Drug names

ARA 290

Primary outcome measures

Changes from baseline to week 12 (+ or - 7 days) in best corrected distance visual acuity

Secondary outcome measures

Changes from baseline to week 12 (+ or - 7 days) in:
1. Central subfield thickness
2. Central retinal sensitivity
3. Retinal perfusion
4. Tear production
5. Patient reported outcomes
6. Inflammatory markers
7. Carbamylated and glycosylated albumin
8. ARA 290 antibodies
9. Adverse events
10. Best corrected distance visual acuity
11. Central subfield retinal thickness
12. Retinal perfusion, as determined by fundus fluorescein angiography
13. Macular function, as determined by macular microperimetry
14. Patient reported outcomes
15. Tear production as determined by the Schirmer test
16. Anti-ARA 290 antibodies and inflammatory biomarkers

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Patients with diabetic retinopathy and centre involving DMO with a central subfield thickness of > 400 microns, as determined using SD-OCT
2. >= 18 years of age
3. Clear media and naïve to previous treatments for DMO

Participant type


Age group




Target number of participants

10 patients will be recruited

Participant exclusion criteria

1. Macular oedema related to other retinal disease
2. Hazy media that prevents adequate retinal imaging
3. Allergy to fluorescein
4. Previous treatments for DMO
5. DMO with central subfield thickness of < 400 microns
6. Patients on systemic or topical steroids
7. Use of erythropoiesis stimulating agents within the two months prior to screening or during the trial
8. Treated with any other investigational medication or device within 60 days
9. Pregnant women, women who have not yet reached the menopause (no menses for ≥ 12 months without an alternative medical cause) who test positive for pregnancy, are unwilling to take a pregnancy test prior to trial entry or are unwilling to undertake adequate precautions to prevent pregnancy for the duration of the trial.
10. Female patients who are breastfeeding
11. Active proliferative diabetic retinopathy (PDR) requiring treatment.
12. Patients with other eye diseases besides diabetic retinopathy
13. Patients who are unable or unwilling to commit to the study schedule of events

Any patient showing improvement between the initial screening and presenting for the first screening/baseline visit will no longer be eligible for the study, will be recorded as a screen failure and will not be entered on to the study

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Belfast Health & Social Care Trust (BHSCT)
United Kingdom

Sponsor information


Belfast Health & Social Care Trust (UK)

Sponsor details

The Royal Hospitals
Grosvenor Road
BT12 6BA
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Araim Pharmaceuticals Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

The final study report will be provided by the Trial Statistician; it is anticipated that the study findings will be published in national and international peer review journals which will be led by the Chief Investigator. This will secure a searchable compendium of these publications and make the results readily accessible to the public and health care professionals. In addition study findings may be presented at both national and international meetings and also to appropriate patient groups. Publication and dissemination date - to be confirmed at a later date.

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/03/2016: Ethics approval information added.