The Use of ARA290 for the Treatment of Diabetic Macular Oedema (ARA290DMO)

October 2, 2024 updated by: Belfast Health and Social Care Trust

A Phase II Clinical Trial on the Use of ARA 290 for the Treatment of Diabetic Macular Oedema

ARA 290-DMO is a prospective, open label, interventional, single centre, investigator led, phase II trial to examine the effect of ARA 290 on diabetic macular oedema in patients with type 1 or 2 diabetes.

The aim or primary objective of the study was to determine whether ARA 290 administered at a daily dose of 4mg subcutaneously for 12 weeks to patients with diabetes mellitus (DM) and DMO would have a beneficial effect on mean change in best corrected visual acuity (BCVA) from baseline values to week 12.

Study Overview

Status

Terminated

Conditions

Diabetic Macular Oedema

Intervention / Treatment

Drug: ARA290

Detailed Description

Diabetic retinopathy a very 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 and steroids. Anti VEGF drugs have been very helpful in the treatment of DMO. However, anti VEGF drugs need to be given by an injection into the eye, an Ophthalmologist (eye specialist) or a specialist nurse (a nurse trained for this purpose) will need to deliver this treatment to patients with DMO in the hospital.

Furthermore, patients require injections every four weeks during the first months of treatment and long term treatment is required. Moreover, not all patients respond to anti VEGFs: In 40% of patients the sight may 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.

Given the above facts there appeared a clear need to develop new treatments for people with DMO. ARA 290 is a drug that has marked 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, it was thought that ARA 290 could potentially be helpful in treating patients with this condition. In light of this, the Investigators carried out this study to find out if ARA 290 was effective in drying the fluid in DMO. If this treatment was successful, benefits may have included a reduction of the demands on health care services and patient benefits of: self administration of the drug at home by the patients; a reduction in hospital visits; treatment of both eyes at once, reduced risks associated with injections; a more pleasant treatment (subcutaneous injection versus an injection into the eye).

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United Kingdom
- Co Antrim
  - Belfast, Co Antrim, United Kingdom, BT12 6BA
    - Belfast Health & Social care Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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

Exclusion Criteria:

Macular oedema related to other retinal disease
Hazy media that prevents adequate retinal imaging
Allergy to fluorescein
Previous treatments for DMO
DMO with central subfield thickness of < 400 microns
Patients on systemic or topical steroids
Use of erythropoiesis stimulating agents within the two months prior to screening or during the trial
Treated with any other investigational medication or device within 60 days
Pregnant women, women who have not yet reached the menopause (no menses for 12 months or more without an alternative medical cause) who test positive for pregnancy or who 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.
Men who have a female partner and who are unwilling to undertake adequate precautions to prevent pregnancy for the duration of the trial.
Female patients who are breastfeeding
Active proliferative diabetic retinopathy (PDR) requiring treatment.
Patients with other eye diseases besides DR
Patients who are unable or unwilling to commit to the study schedule of events
Serious illness that is likely to affect the patient's ability to complete the study

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention Subcutaneous daily injection of ARA 290 at a dose of 4mg for 12 weeks.	Drug: ARA290 4 mg subcutaneous injections of ARA290 over an 84 day period Other Names: L-Pyroglutamyl-L-glutamyl-L-glutaminyl-L-leucyl-L-glutamyl-L-arginyl-L-alanyl-L-leucyl-L-asparaginyl-L-seryl-L-serine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome - Best corrected distance visual acuity. Time Frame: From baseline to week 12 (+/- 7 days)	Best corrected distance visual acuity will be obtained in both eyes by a trained optometrist using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts at baseline and at week 12. The EDTRS total score will be recorded and used for the analysis.	From baseline to week 12 (+/- 7 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome - Central subfield thickness Time Frame: Changes from baseline to week 12 (+/- 7 days).	Central subfield retinal thickness (CST), as obtained in the central 1 mm area, will be determined by spectral domain optical coherence tomography (SD-OCT) and used for the analysis.	Changes from baseline to week 12 (+/- 7 days).
Secondary Outcome - Central retinal sensitivity Time Frame: Changes from baseline to week 12 (+/- 7 days)	Retinal sensitivity will be determined by macular microperimetry in both eyes.	Changes from baseline to week 12 (+/- 7 days)
Secondary Outcome - Retinal perfusion Time Frame: Changes from baseline to week 12 (+/- 7 days)	Retinal perfusion will be assessed by wide angle fundus fluorescein angiography (FFA).	Changes from baseline to week 12 (+/- 7 days)
Secondary Outcome - Tear production Time Frame: Changes from baseline to week 12 (+/- 7 days)	The Schirmer test will be performed to measure tear production.	Changes from baseline to week 12 (+/- 7 days)
Secondary Outcome - Patient reported outcome Time Frame: Changes from baseline to week 12 (+/- 7 days)	Patient reported outcomes will be evaluated by means of EQ-5D 5L questionnaires which will be administered to patients at baseline and at week 12 (and at week 16 if applicable).	Changes from baseline to week 12 (+/- 7 days)
Secondary Outcome - Change in inflammatory markers Time Frame: Changes from baseline to week 12 (+/- 7 days)	A blood sample will be used to test for ARA 290 antibodies and to complete an exploratory analysis to determine levels of inflammatory markers and carbamylated and glycosylated albumin.	Changes from baseline to week 12 (+/- 7 days)
Secondary Outcome - Number of Adverse events Time Frame: Changes from baseline to week 12 (+/- 7 days)	Adverse events	Changes from baseline to week 12 (+/- 7 days)
Secondary Outcome -% of participants with ≥ 15 ETDRS letter gain Time Frame: baseline to week 12	using Best corrected distance visual acuity	baseline to week 12
Secondary Outcome -% of participants with ≥ 10 ETDRS letter gain Time Frame: baseline to week 12	using Best corrected distance visual acuity	baseline to week 12
Secondary Outcome - Patient reported outcomes Time Frame: Changes from baseline to week 12 (+/- 7 days)	Patient reported outcomes will be evaluated by means of NEI VFQ-25 questionnaires which will be administered to patients at baseline and at week 12 (and at week 16 if applicable).	Changes from baseline to week 12 (+/- 7 days)
Secondary Outcome - Change in glycosylated albumin Time Frame: Changes from baseline to week 12 (+/- 7 days)	A blood sample will be used to test for ARA 290 antibodies and to complete an exploratory analysis to determine levels of inflammatory markers and carbamylated and glycosylated albumin.	Changes from baseline to week 12 (+/- 7 days)
Secondary Outcome - Change in carbamylated albumin Time Frame: Changes from baseline to week 12 (+/- 7 days)	A blood sample will be used to test for ARA 290 antibodies and to complete an exploratory analysis to determine levels of inflammatory markers and carbamylated and glycosylated albumin.	Changes from baseline to week 12 (+/- 7 days)

Other Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Belfast Health and Social Care Trust

Collaborators

Araim Pharmaceuticals, Inc.

Investigators

Study Chair: Noemi Lois, Belfast Health & Social Care Trust and Queen's University Belfast

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

May 12, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

March 28, 2018

First Submitted That Met QC Criteria

October 2, 2024

First Posted (Actual)

October 4, 2024

Study Record Updates

Last Update Posted (Actual)

October 4, 2024

Last Update Submitted That Met QC Criteria

October 2, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

14166NL-AS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Macular Oedema

University of Sydney

Completed

Intravitreal Triamcinolone for Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment (TDMO)

Diabetic Macular Oedema

Australia
Odense University Hospital
Moorfields Eye Hospital NHS Foundation Trust

Completed

Aflibercept anD navigateD vErsus coNvensional Laser in Diabetic macUlar edeMa (ADDENDUM)

Diabetic Macular Oedema

Denmark
University of Sydney

Completed

Open Label Extension of a Clinical Trial of Intravitreal Triamcinolone for Diabetic Macular Oedema-TDMX Study

Diabetic Macular Oedema

Australia
University of Sydney
University of Melbourne; The University of Western Australia; Marsden Eye Specialists

Completed

A Multicentre Randomised Clinical Trial of Laser Treatment Plus Intravitreal Triamcinolone for Diabetic Macular Oedema

Diabetic Macular Oedema

Australia
Belfast Health and Social Care Trust
Queen's University, Belfast

Recruiting

Anti-vascular Endothelial Growth Factor (Anti-VEGF) Monotherapy vs Anti-VEGF Followed by Subthreshold Micropulse Laser for Treating Severe Diabetic Macular Oedema When the Central Retina Goes <400 Microns (DAME)

Severe Diabetic Macular Oedema

United Kingdom
Innovent Biologics Technology Limited (Shanghai...

Active, not recruiting

A Study to Evaluate the Efficacy and Safety of IBI302 inSubjects With Diabetic Macular Edema（DME）

Diabetic Macular Oedema

China
Manchester University NHS Foundation Trust
Topcon Corporation; Optos, PLC

Withdrawn

Sub-threshold Photocoagulation of Diabetic Macular Oedema (MEM)

Diabetic Macular Oedema

United Kingdom
Allergan

Completed

Study of OZURDEX® in the Treatment of Diabetic Macular Oedema (DME) in Australia - The AUSSIEDEX Study

Diabetic Macular Oedema

Australia
University of Oxford
Pfizer

Completed

Intravitreal Macugen for Ischaemic Diabetic Macular Oedema (MIDME)

Diabetic Macular Oedema

United Kingdom
Ripple Therapeutics Pty Ltd
Novotech (Australia) Pty Limited

Completed

Safety and Efficacy of IBE-814 Intravitreal (IVT) Implant - a Sustained, Low Dose Dexamethasone Therapy

Diabetic Macular Oedema | Retinal Vein Occlusion with Macular Oedema

Australia, New Zealand, Hong Kong, Canada

Clinical Trials on ARA290

Leiden University Medical Center

Completed

Cognitive and Neural Effects of ARA290 (CONEARA)

Depression

Netherlands

The Use of ARA290 for the Treatment of Diabetic Macular Oedema (ARA290DMO)

A Phase II Clinical Trial on the Use of ARA 290 for the Treatment of Diabetic Macular Oedema

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Clinical Trials on Diabetic Macular Oedema

Clinical Trials on ARA290

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations