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Trial · Interventional

TerminatedPhase 2Registry data

The Use of ARA290 for the Treatment of Diabetic Macular Oedema

Short name ARA290DMO

NCTNCT06626971 (opens ClinicalTrials.gov in a new tab)Other id14166NL-AS
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 2
Enrollment
9 participants (actual)
Sponsor
Belfast Health and Social Care Trust · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United Kingdom

Start
Apr 2016
Primary completion
12 May 2017
Completion
Aug 2017
First posted
4 Oct 2024
Last update posted
4 Oct 2024
Conditions
Diabetic Macular Oedema

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018
  1. Ph 2

    ARA290DMO

    NCT06626971

    Apr 2016 to Aug 2017

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • ARA290Drug

Arms1

  • Other

    Intervention

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Primary Outcome - Best corrected distance visual acuity.

    Time frame · From baseline to week 12 (+/- 7 days)

    Registry description

    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.

Secondary outcomes(12)

  1. Secondary Outcome - Central subfield thickness

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

    Registry description

    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.

  2. Secondary Outcome - Central retinal sensitivity

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

    Registry description

    Retinal sensitivity will be determined by macular microperimetry in both eyes.

  3. Secondary Outcome - Retinal perfusion

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

    Registry description

    Retinal perfusion will be assessed by wide angle fundus fluorescein angiography (FFA).

  4. Secondary Outcome - Tear production

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

    Registry description

    The Schirmer test will be performed to measure tear production.

  5. Secondary Outcome - Patient reported outcome

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

    Registry description

    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).

  6. Secondary Outcome - Change in inflammatory markers

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

    Registry description

    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.

  7. Secondary Outcome - Number of Adverse events

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

    Registry description

    Adverse events

  8. Secondary Outcome -% of participants with ≥ 15 ETDRS letter gain

    Time frame · baseline to week 12

    Registry description

    using Best corrected distance visual acuity

  9. Secondary Outcome -% of participants with ≥ 10 ETDRS letter gain

    Time frame · baseline to week 12

    Registry description

    using Best corrected distance visual acuity

  10. Secondary Outcome - Patient reported outcomes

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

    Registry description

    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).

  11. Secondary Outcome - Change in glycosylated albumin

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

    Registry description

    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.

  12. Secondary Outcome - Change in carbamylated albumin

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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Patients with DR 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. 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 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. 10. Men who have a female partner and who are unwilling to undertake adequate precautions to prevent pregnancy for the duration of the trial. 11. Female patients who are breastfeeding 12. Active proliferative diabetic retinopathy (PDR) requiring treatment. 13. Patients with other eye diseases besides DR 14. Patients who are unable or unwilling to commit to the study schedule of events 15. 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.

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