Topic: Diabetes, Ophthalmology
Conditions
Interventions
Patients with OCT confirmed DMO and wFFA confirmed peripheral retinal ischaemia will be randomised to PRP + Ranibizumab or Ranibizumab monotherapy as per pre-defined criteria.
Study Entry : Single Ran
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Visual acuity 20/30 to 20/300 2. Macular oedema secondary to diabetic retinopathy. (OCT Thickness of >300 micrometres central subfield, on spectral domain OCT (Spectralis OCT Heidelberg engineering) 3. EDTRS grade 53 – 57 up to non high-risk proliferative diabetic retinopathy 4. Peripheral ischaemia seen on wFFA 5. Patient able to give consent and take part in all study procedures 6. In the opinion of the investigator the patient should benefit from treatment
Exclusion criteria
Exclusion criteria: 1. Visual acuity worse than 20/300 2. Rubeosis 3. Proliferative retinopathy with high risk characteristics 4. Unable to give consent or take part in all study procedures 5. Other conditions that might interfere with the assessment of the eye such as cataract or prevent the macular oedema from settling such as vitreomacular traction, epiretinal membrane, to a degree that would in the opinion of the investigator affect response to treatment; conditions that would prevent the visual acuity improving such as foveal atrophy, uveitis 6. Previous macular laser within 3 months in the study eye 7. Previous peripheral (PRP) laser in the study eye 8. Previous injection therapy within last 4 months (anti VEGF) 6 months (steroid) in the study eye 9. Pregnant 10. Uncontrolled systemic illness that in the opinion of the investigator would preclude involvement 11. Cataract or other intraocular surgery within 3 months 12. Previous vitrectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of repeat Ranibizumab injections required after the first 6 months up until one year post treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Length of treatment free interval 2. Difference in visual acuity at one year 3. Difference in time | — |
Countries
England, United Kingdom
Outcome results
None listed