se of ARA 290 for the treatment of diabetic macular oedema
- Conditions
- Diabetic macular oedema (DMO)Eye Diseases
- Registration Number
- ISRCTN16962255
- Lead Sponsor
- Belfast Health & Social Care Trust (UK)
- Brief Summary
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32674280/ (added 04/07/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 9
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
Exclusion criteria as of 08/12/2016:
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 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.
Original 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome measures as of 20/01/2017:<br>Best corrected distance visual acuity is measured using Early Treatment Diabetic Retinopathy Study (ETDRS) charts at baseline, weeks 4, 8 and 12 (+ or - 7 days). If at week 12 the retina is dry, a further visit will be arranged at week 16 to measure BCVA.<br><br>Original primary outcome measure:<br>Changes from baseline to week 12 (+ or - 7 days) in best corrected distance visual acuity
- Secondary Outcome Measures
Name Time Method