Randomised Controlled Trial Of Intravitreal Triamcinolone In Patients With Diabetic Macular Oedema Refractory To Laser Treatment
- Conditions
- Diabetic macular oedema affecting vision and refractory to laser treatment
- Registration Number
- EUCTR2005-000397-45-GB
- Lead Sponsor
- Queen's Medical centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
: -
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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method