Diabetic macular oedema Eye Diseases Diabetic macular oedema
Conditions
Interventions
Participants are randomised to one of two groups in a 1:1 ratio by an automated randomisation system to generate the random allocation sequence.
Intervention group: Participants undergo treatment wit
Sponsors
Belfast Health & Social Care Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with diabetic retinopathy and centre involving DMO, as determined by using spectral domain optical coherence tomography (SD-OCT), in one or both eyes with: 1. Central retinal subfield thickness of >300 but 24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (Snellen equivalent > 20/320) 4. Amenable to laser treatment, as judged by the treating ophthalmologist 5. Over 18 years of age
Exclusion criteria
Exclusion criteria: Eyes of patients will not be included in the study if: 1. The macular oedema is due to causes other than diabetic macular oedema such as epiretinal membrane, vitreomacular traction, vein occlusion, or others 2. The eye is ineligible for macular laser treatment, as judged by the treating ophthalmologist 3. The eye has DMO and central subfield retinal thickness (CST) of >400 microns. 4. The eye has active proliferative diabetic retinopathy (PDR) requiring treatment. 5. The eye has received intravitreal Anti- Vascular Endothelical Growth Factor (Anti-VEGF) therapy within the previous two months. 6. The eye has received macular laser treatment within the previous 12 months. 7. The eye has received intravitreal injection of steroids. 8. The eye has received cataract surgery within the previous six weeks 9. The eye has received panretinal photocoagulation within the previous 3 months The patient: 1. Is on pioglitazone and the drug cannot be stopped 3 months prior to entering into the trial and for the duration of the study 2. Has chronic renal failure requiring dialysis or kidney transplant 3. Has 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) 4. Has very poor glycemic control and started intensive therapy within the previous 3 months 5. Will use an investigational drug during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BCdVA in the study eye is assessed by a BCdVA test (using ETDRS visual acuity charts at 4 meters) at baseline and months 4,8,12,16,20 and 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Binocular BCdVA is assessed by a binocular BCdVA test (using ETDRS visual acuity charts at 4 meters) at baseline and 24 months 2. Central subfield retinal thickness, as determined by spectral domain OCT at baseline and 24 months 3. Mean deviation (MD) of the Humphrey 10-2 visual field is assessed by a Humphrey 10-2 visual field test at baseline, 12 and 24 months 4. Percentage (%) of people meeting driving standards is assessed by an Esterman binocular visual field test at baseline and 24 months 5. Visual functioning (NEI VFQ-25), general health (EQ-5D-5L) and vision and quality of life (VisQol) are measured using NEI VFQ25, EQ-5D 5L and VisQoL questionnaire scores at baseline and 24 months 6. Incremental cost per quality-adjusted life year (QALY) gained is assessed by a Markov model based cost-utility analysis which will extend beyond the trial analysis period to estimate the longer-term cost-effectiveness, with costs and benefits discounted at 3.5%. The model will be populated by data from the trial and supplemented by estimates of effectiveness, quality of life and costs from published literature and expert opinion. 7. Side effects are measured by a review of the participant’s medical and ophthalmic history at 4, 8, 12, 16, 20, 24 months 8. Number of laser treatments needed is assessed by the treating ophthalmologist at 4, 8, 12, 16, 20, 24 months 9. Use of additional treatments (other than laser) is assessed by the treating ophthalmologist at 4, 8, 12, 16, 20, 24 months | — |
Countries
England, Northern Ireland, United Kingdom
Contacts
Public ContactLynn Murphy
Outcome results
None listed