Macular oedema Ear, Nose and Throat Macular oedema
Conditions
Interventions
1. Ozurdex 700µg dose intravitreal implant will be given to all patients at baseline
2. Patients will then be followed up 4 weekly for 36 weeks
3. Re-treatment with the same drug is allowed at 16th, 2
Sponsors
King's College NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 or above 2. Ability to provide informed consent 3. Diagnosis of macular oedema secondary to diabetic maculopathy, branch and central retinal vein occlusion or pseudophakic cystoid macular oedema or post-inflammatory macular oedema 4. Central macular thickness on OCT should be above 250µm 5. Best corrected visual acuity in the study eye between 37 and 68 letters
Exclusion criteria
Exclusion criteria: 1. Any other eye disease which could mask macular oedema 2. Known uncontrolled systemic disease or current immunosuppressive disease 3. Initiation of medical therapy for diabetes or a change from oral hypoglycaemic agents to insulin therapy within 4 months prior to the screening visit 4. Renal failure requiring haemodialysis or peritoneal dialysis within 6 months prior to screening visit 5. Any ocular condition in the study eye that in the opinion of the investigator would prevent a 15-letter improvement in visual acuity (e.g., severe macular ischemia, extensive macular laser scarring or atrophy) 6. Presence of an epiretinal membrane or vitreo-retinal interface changes in the study eye which, in the opinion of the investigator, is the primary cause of macular oedema, or is severe enough to prevent improvement in visual acuity despite reduction in macular oedema 7. Active or suspected ocular or periocular infection including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases 8. Advanced glaucoma which cannot be adequately controlled by medicinal products alone 9. History of IOP elevation in response to steroid treatment in either eye that resulted in any of the following: 9.1. >10 mm Hg increase in IOP from baseline with an absolute IOP > 25 mm Hg 9.2. Required therapy with 3 or more anti-glaucoma medications 10. Pregnancy if child bearing age (confirmed by pregnancy test) and to avoid pregnancy during the 36 weeks of the study. Pregnancy test will not be done in post-menopausal women (defined as 12 months post LMP) 11. Breast feeding women will be excluded 12. Hypersensitivity to the active substance or to any of the excipients 13. Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in OCT at 4 weekly time points | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean change in macular thickness at week 24 2. Mean change in visual acuity at week 24 3. Proportion with gain of 15 ETDRS letters or more (improvement) from screening at week 24 4. Proportion with loss less than 15 ETDRS letters (stabilization) from screening at week 24 5. Proportion of patients with gain of 0, 5 and 10 letters from screening at week 24 6. Mean Change in other visual functions at week 24: 6.1. Change in contrast sensitivity 6.2. Change in colour vision 6.3. Change in reading vision 6.4. Change in microperimetry thresholds 6.5. Change in fixation on microperimetry 7. Efficacy parameters that will be assessed at week 36: 7.1. Mean change in visual acuity and macular thickness at week 36 7.2. Proportion with gain of 15 ETDRS letters or more (improvement) from screening at week 36 7.3. Proportion with loss less than 15 ETDRS letters (stabilization) from screening at week 36 7.5. Proportion of patients with recurrence of oedema (increase macular thickness by 100µm from baseline to 36 weeks at each 4 weekly time point from baseline | — |
Countries
United Kingdom
Outcome results
None listed