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ISRCTN
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ISRCTN67086909
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ClinicalTrials.gov identifier
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Public title
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Intravitreal versus subtenon triamcinolone acetonide for the treatment of diabetic cystoid macular oedema
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Macular oedema is the main cause of loss of visual acuity in diabetic patients. It may occur at any stage of the retinal disorder and is the most common cause of sight reductions in these subjects.
In the oedema, the haemato-retinal barrier is damaged by an alteration in the tight junction between the retinal capillary endothelial cells and the pigmented epithelial cells with the consequent leakage of water and electrolytes in the retinal tissue.
The use of corticosteroids for the treatment of retinal oedema is linked to their capacity to inhibit the initial arachidonic acid cascade, to determine a down-regulation of the cytokines and to attenuate the tearing of the haemato-retinal barrier.
Hypothesis:
To assess the efficacy of the intravitreal (IVT) injection of triamcinolone acetonide (TA) as compared to posterior subtenon (SBT) capsule injection for the treatment of cystoid diabetic macular oedema.
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Ethics approval
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Ethics approval received from the Institutional Ethics Committee of the S. Orsola-Malpighi Hospital on the 12th September 2006 (ref: OFC06-01).
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Study design
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An interventional randomised double-blind study
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Countries of recruitment
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Italy
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Disease/condition/study domain
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Macular oedema
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Participants - inclusion criteria
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1. Patients aged between 61 and 74 years (mean 68.3), either sex
2. With type II diabetes mellitus
3. On insulin treatment
4. Presenting diffuse macular oedema without retinal-vitreous traction
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Participants - exclusion criteria
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1. History of focal/grid laser photocoagulation in the macula
2. Record of uveitis episodes
3. Previous ocular surgery, glaucoma and ocular hypertension
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Anticipated start date
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03/02/2004
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Anticipated end date
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18/10/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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28
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Interventions
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For the IVT injection, the patient was placed supine and we performed a surface anaesthesia with topical 4% carbocaine followed by a preparation with 5% povidone iodine. A volume of 0.1 ml containing 4 mg preservative-free TA (Kenacort, Bristol-Myers Squibb, Sermoneta, Italy) was injected through the inferotemporal pars-plana (4.0 mm posterior to the limbus) using a 30-gauge needle.
For the SBT injection, the patient was placed supine and after topical 0.4% oxybuprocaine surface anaesthesia we administered 0.5 ml of a 40 mg/ml peribulbar inferotemporal subtenon injection of preservative-free TA (Kenacort, Bristol-Myers Squibb, Sermoneta, Italy) with a 27-gauge needle.
The follow-up was of 6 months for all treatment arms.
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Primary outcome measure(s)
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Visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, measured every month until the end of follow-up.
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Secondary outcome measure(s)
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Macular thickness was measured by optical coherence tomography (OCT), measured every month until the end of follow-up.
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Sources of funding
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St Orsola Malpighi University Hospital Bologna (Italy)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/18366650
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Contact name
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Dr
Mauro
Cellini
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Address
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Via Massarenti, 9
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City/town
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Bologna
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Zip/Postcode
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40100
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Country
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Italy
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Sponsor
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St Orsola Malpighi University Hospital Bologna (Italy)
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Address
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Ophthalmology Service
Department of Surgery and Transplant
via Massarenti, 9
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City/town
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Bologna
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Zip/Postcode
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40138
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Country
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Italy
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Date applied
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05/02/2008
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Last edited
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15/04/2008
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Date ISRCTN assigned
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20/02/2008
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