Severe diabetic macular oedema (DMO). Eye Diseases
Conditions
Interventions
Comparator Arm: Anti-VEGF Monotherapy (standard care)
Anti-VEGFs including ranibizumab and biosimilars, aflibercept, faricimab, and brolucizumab will be used, as per the standard of care at participat
7-12), type of anti-VEGF used (ranibizumab, ranibizumab-biosimilar, Brolucizumab, aflibercept, or faricimab) up to the time of randomisation, which will be continued throughout the trial unless lack o
logMAR = 0.3), 24–68 ETDRS letters (Snellen equivalent =20/50-20/320
logMAR 0.4–1.2) and CI-DMO (Yes, No). Minimising randomisation by these variables will ensure both trial arms will be balanced with regard to these potentially important baseline characteristics.
Sponsors
Belfast Health and Social Care Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adults (>18 years) 2. Diabetes type 1 or type 2 3. Presented with severe centre-involving (CI)-DMO (CRT =400 µm) 4. Within the first year of initiating anti-VEGF therapy but who still have DMO and their CRT is below 400 µm (and it remains, at the time of randomisation) following anti-VEGF therapy in either one eye or both eyes
Exclusion criteria
Exclusion criteria: 1. Causes of macular oedema other than DMO 2. DMO with CRT =400 µm 3. Receipt of anti-VEGFs before their presentation with severe DMO (previous macular laser treatment for DMO is allowed) 4. Use of unlicensed anti-VEGFs (e.g. bevacizumab) 5. Inability, for any reason, to attend study visits 6. Active proliferative diabetic retinopathy (PDR) (treated and inactive PDR is allowed) 7. Use of pioglitazone which cannot be stopped for the duration of the trial 8. Cataract surgery or laser pan-retinal photocoagulation (PRP) within the previous 6 weeks 9. Currently enrolled in a CTIMP (Clinical Trial of an Investigational Medical Product) 10. Declined consent for participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in best corrected visual acuity (BCVA) in the study eye from randomisation (baseline) to 104 weeks (24 months) (equivalence margin +/- 5 ETDRS letters) | — |
Secondary
| Measure | Time frame |
|---|---|
| All measured at 104 weeks (24 months) from randomisation: 1. Central Retinal Thickness in the study eye. CRT in the central 1 mm of the retina as measured using Spectral-Domain optical Coherence Tomography (SD- OCT) 2. Health-related and vision-related quality of life. National Eye Institute Visual Function Questionnaire (NEI VFQ) 25 and the EuroQoL (EQ 5D 5L) questionnaire 3. Safety based on determined safety outcomes, adverse events, and serious adverse events 4. Number of treatments used (anti-VEGF injections, SML sessions) in the study eye from baseline to week 104 5. Number/proportion of people receiving “rescue” treatment in the study eye from baseline to week 104 6. Number of rescue treatments received in the study eye from baseline to week 104 7. Number/proportion of people discontinuing treatment (with reasons) 8. Number/proportion of people losing (with reasons) =5, =10 and =15 ETDRS letters of best-corrected visual acuity (from baseline to week 104) in the study eye 9. Number/proportion of people gaining =5, =10 and =15 ETDRS letters (from baseline to week 104) in the study eye 10. Number/proportion of people with CRT =300µm in the study eye in the central 1 mm if the retina as determined using SD-OCT 11. Number/proportion of people with no DMO, as determined by the ophthalmologists evaluating the patient 12. Health and social care service use and non-healthcare costs as determined using a Health Service Use Questionnaire and Patient Cost Questionnaire 13. Participant experience and acceptability as determined by focus group discussions, the Acceptability Questionnaire ( Theoretical Framework of Acceptability (TFA) ) distributed at week 104, and also by the use of Visual Analogue Score questionnaires that will be distributed 60 minutes prior to treatment, immediately after treatment and 24 hours after treatment at all instances in which treatment is given | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactMary Guiney
Outcome results
None listed