Diabetic macular oedema affecting vision and refractory to laser treatment
Conditions
Interventions
Trade Name: kenalog
Product Name: kenalog
Pharmaceutical Form: Injection*
Sponsors
Queen's Medical centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria:: - All eyes with persistent CSME involving the center of the fovea as judged by slit lamp biomicroscopy and confirmed by active fluorescein leakage on FFA All eyes with previous focal or at least one session of grid laser treatment with the last one being at least 3 months prior to the examaination and deemed to be complete by one of the observers masked to the eventual randomisation - patients could be phakic or pseudophakic Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: - Excessive ischaemic diabetic maculopathy as judged clinically and/or on fluorescein angiography by >75% destruction of the outline of the foveal avscular zone (FAZ) - patients with large plaques of sub-foveal exudates - patients with active neovascular disease -patients with high blood pressure (> 180/110) -patients with documented renal disease - patients on non steroidal antiinflammatories, systemic prednisolone, methotrexate, diamox. low dose aspirin is not an exclusion criteria and will be allowed on the trial -all patients on warfarin -coexisting glaucoma -history of increased IOP on steroid drops or tablets or ocular hypertension -patients with any other significant ocular pathology affecting the macula eg age related macular degenration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: safety of the injection outcome measures: intraocular pressure measurements record of intrainjection and postinjection complications such as endophthalmitis, cataract, lens injury etc. ; Main Objective: to evaluate the efficacy of intravitreal injection of triamcinolone in patients with diabetic macular oedema that is unresponsive yo previous macular grid laser treatment outcome measures: visual acuity macular retinal thickness ; Primary end point(s): Pre-injection and then at month 1, 3 and 6. 1. Best corrected visual acuity (logMAR) at each visit. A change in either direction of 10 letters on the logmar chart would be considered significant . 2. near vision tested with a standard add on each visit, with time taken to read the standard N paragraph and the number of mistakes made. 3. Intra-ocular pressure at each visit- measured by standard applanation tonometry. 4. Evaluation of Clinically significant macular edema by 78 D fundus lens or contact lens biomicroscopy at each visit. 5. Multifocal ERG for all patients on the drug and placebo arm of the trial at the pre injection and 3 months visit. 6. Ocular coherence tomography for retinal thickness before and at 1 and 6 months months 7. Lenticular status on the slit lamp with dilated pupils (Oxford System) or LOCS III8. Quality of life questionaire VF-14 before and at the end of the final follow up | — |
Countries
United Kingdom
Outcome results
None listed