Diabetic macular oedema (DMO) Eye Diseases Diabetic macular oedema (DMO)
Conditions
Interventions
The patient will be required to self administer a subcutaneous injection of ARA 290 in their own home, at a dose of 4 mg daily for a period of 12 weeks. The patient will be monitored carefully with a
vital signs
ETDRS BCVA
Wide angle fundus photographs and fluorescein angiography (FFA)
Urine collection
C-SSRS
NEI VFQ-25.
Weeks 4 & 8 (+/-7days): Vital signs
Record of adverse events
C-SSRS.
Week 12 (+/-7days): vital signs
Sponsors
Belfast Health & Social Care Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures as of 20/01/2017: 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. Original primary outcome measure: Changes from baseline to week 12 (+ or - 7 days) in best corrected distance visual acuity | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures as of 20/01/2017: 1. Central subfield thickness is measured using spectral domain optical coherence tomography (SD-OCT) at baseline, weeks 4, 8 and week 12 (+ or - 7 days) 2. Central retinal sensitivity is measured using “macular microperimetry” at baseline and week 12 (+ or - 7 days) 3. Retinal perfusion is measured using wide angle fundus fluorescein angiography (FFA) at baseline and week 12 (+ or - 7 days) 4. Tear production is measured using Schirmer test at baseline and week 12 (+ or - 7 days) and week 16 if applicable 5. Patient reported outcomes are measured using “EQ-5D 5L and NEI VFQ-25 at baseline and week 12 (+ or - 7 days) 6. ARA 290 antibodies are measured using “blood sample at baseline and week 12 (+ or - 7 days) and week 16 if the macular oedema resolved at week 12 7. Adverse events are assessed by the PI or designee who will ask at each visit (weeks 4, 8, 12 (and week 16 if applicable) if the patient has experienced any AEs. In addition the patient will be telephoned at week 2 and asked if they have experienced any AEs and again 4 weeks post study drug termination) Original secondary outcome measures: Changes from baseline to week 12 (+ or - 7 days) in: 1. Central subfield thickness 2. Central retinal sensitivity 3. Retinal perfusion 4. Tear production 5. Patient reported outcomes 6. Inflammatory markers 7. Carbamylated and glycosylated albumin 8. ARA 290 antibodies 9. Adverse events 10. Best corrected distance visual acuity 11. Central subfield retinal thickness 12. Retinal perfusion, as determined by fundus fluorescein angiography 13. Macular function, as determined by macular microperimetry 14. Patient reported outcomes 15. Tear production as determined by the Schirmer test 16. Anti-ARA 290 antibodies and inflammatory biomarkers | — |
Countries
Northern Ireland, United Kingdom
Contacts
Public ContactNuala Jane Lavery
Outcome results
None listed