A phase II Clinical Trial on the use of ARA 290 for the treatment of diabetic macular oedema

Phase 1

• Conditions: Diabetic macular oedema; MedDRA version: 18.0 Level: LLT Classification code 10057915 Term: Diabetic macular oedema System Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2015-001940-12-GB
• Lead Sponsor: Belfast Health & Social Care Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-09
• Study Completion: 2017-08-29
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 9

Inclusion Criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

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
14. Serious illness that is likely to affect the patient's ability to complete the study

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified