Diabetic macular oedema Eye Diseases
Conditions
Interventions
Eligible patients will only be enrolled after receiving three loading doses of Ranibizumab or Aflibercept, with subsequent (1:1) randomisation to the treatment or control group.
The treatment group w
Sponsors
Guy's and St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient over 18 years of age 2. Patient has the capacity to give informed consent 3. Patient has not previously been enrolled in this study in regards to their other eye 4. Symptomatic visual loss attributable to diabetic macular edema for less than one year 5. Patient has a formal diagnosis of diabetes mellitus 6. Patient has an HbA1c test (a blood test that looks at long term diabetic control) performed within the past 2 months 7. Ophthalmic criteria: 7.1. Symptomatic visual loss attributable to DME for less than one year 7.2. Best corrected visual acuity of better than 35 letters on formal testing 7.3. Central macular swelling greater than 350 microns
Exclusion criteria
Exclusion criteria: 1. History of chronic renal failure requiring dialysis or transplantation 2. Patient suffered a major thromboembolic event within the past 6 months as (defined as TIA, stroke, or MI) 3. Patient has undergone major surgery within the past 6 months or has major surgery planned over the next 12 months defined as requiring GA or reduced mobilisation 4. Known adverse reaction to anti-VEGF medications 5. Blood pressure greater than 180 systolic or 100 diastolic 6. Use of pioglitazone (diabetic medication) 7. Any other condition that in the opinion of the investigator would preclude participation in the study (such as unstable medical status or severe disease that would make it difficult for the patient to be able to complete the study) 8. Very poor glycaemic control and has started intensive therapy within the previous 3 months. 9. The patient will use an investigational drug during the study 10. Previous macular laser within 750 microns of the foveal centre 11. Previous vitrectomy surgery in the study eye 12. Other than intravitreal ranibizumab or aflibercept therapy or cataract surgery: any other laser, surgical or injection therapy in the last 24 weeks 13. Cataract surgery within 3 months 14. Concomitant ophthalmic disease liable to affect central macular thickness or visual acuity 15. Centre involving vitreous haemorrhage 16. Proliferative diabetic retinopathy 17. Presence of visually significant cataract prior to enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Distance best corrected visual acuity measured in the number of ETDRS letters at baseline and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Central macular thickness (CMT) measured on OCT scan over the central 1mm subfield at 12 months 2. Number of injections in 12 months measured documented in patient clinical research forms 3. Trial recruitment measured using number of randomised recruits entered into castor database from trial commencement to Jan 2021 4. Number completed follow up at 12 months measured using completed patient clinical research forms 5. Area under the curve of central macular thickness measured by statistical analysis at 12 months 6. Area under the curve of best corrected visual acuity measured using statistical analysis at 12 months 7. Need for rescue therapy measured using data entered in patient clinical research forms from recruitment to 12 months 8. Need for cataract surgery measured using documented cataract surgery on patient clinical research forms from recruitment to 12 months 9. Complications measured using documented events in patient clinical research forms and submitted serious adverse event forms | — |
Countries
England, United Kingdom
Outcome results
None listed