The Use of ARA290 for the Treatment of Diabetic Macular Oedema

NCT06626971 | Terminated Phase 2 DMC

• 1 other identifier: 14166NL-AS
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Macular Oedema

Outcome Measures

Primary Outcomes (1)

• Primary Outcome - Best corrected distance visual acuity.

  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 Outcomes (12)

• Secondary Outcome - Central subfield thickness

  Changes from baseline to week 12 (+/- 7 days).

• Secondary Outcome - Central retinal sensitivity

  Changes from baseline to week 12 (+/- 7 days)

• Secondary Outcome - Retinal perfusion

  Changes from baseline to week 12 (+/- 7 days)

• Secondary Outcome - Tear production

  Changes from baseline to week 12 (+/- 7 days)

• Secondary Outcome - Patient reported outcome

  Changes from baseline to week 12 (+/- 7 days)

Other Outcomes (89)

• Exploratory Outcome - Change in Adenosine Deaminase (ADA)

  Baseline to week 12 (+/- 7 days)

• Exploratory Outcome - Change in Artemin (ARTN)

  Baseline to week 12 (+/- 7 days)

• Exploratory Outcome - Axin-1 (AXIN1)

  Baseline to week 12 (+/- 7 days)

Study Arms (1)

Intervention

OTHER

Subcutaneous daily injection of ARA 290 at a dose of 4mg for 12 weeks.

Drug: ARA290

Interventions

ARA290 DRUG

4 mg subcutaneous injections of ARA290 over an 84 day period

Also known as: L-Pyroglutamyl-L-glutamyl-L-glutaminyl-L-leucyl-L-glutamyl-L-arginyl-L-alanyl-L-leucyl-L-asparaginyl-L-seryl-L-serine

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Belfast Health and Social Care Trust: lead
• Araim Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Belfast Health & Social Care Trust

Belfast, Co Antrim, BT12 6BA, United Kingdom

Location

MeSH Terms

Interventions

cibinetide

Study Officials

• Noemi Lois

  Belfast Health & Social Care Trust and Queen's University Belfast

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: October 4, 2024
• Study Start: April 1, 2016
• Primary Completion: May 12, 2017
• Study Completion: August 1, 2017
• Last Updated: October 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)