Intravitreal Triamcinolone for Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment (TDMO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00167518|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : September 14, 2005
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Macular Oedema||Drug: Triamcinolone acetate||Phase 2 Phase 3|
Diabetic retinopathy is a common cause of severe loss of visual and the most common cause of legal blindness in individuals between the ages of 20 and 65 years in developed countries. Swelling of the central retina, or "macular oedema" is the commonest cause of visual loss in diabetic retinopathy.
Diabetic macular oedema is treated with laser coagulation to the macular area according to established guidelines which take into account the extent of the leak and its proximity to the centre of the macula, the "fovea". This treatment does not, however, always work and is inherently destructive.
Intravitreal injection of crystalline steroids has been proposed as a new modality to treat clinically significant diabetic macular oedema.
To determine by means of a prospective, double-masked, randomised, placebo-controlled trial to determine whether an intravitreal injection of triamcinolone three months or more after focal or grid laser photocoagulation for clinically significant diabetic macular oedema will improve the visual acuity of eligible eyes. OCT will be used in addition to visual acuity testing as an objective measurement of macular oedema.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Phase II/III Intravitreal Triamcinolone for Treatment of Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment|
|Study Start Date :||March 2002|
|Study Completion Date :||April 2005|
- • Proportion of treated versus untreated eyes with improvement of visual acuity by 5 letters or more on the ETDRS chart at 24 months, no less than 3 months after the most recent treatment episode. An interim analysis of the primary and secondary outcome
- • Incidence of moderate or severe adverse effects related to treatment
- • Any change of visual acuity (treated versus untreated eyes) at 3 months and 24 months after treatment
- • Proportion of treated versus untreated eyes with reduction of macular thickness as demonstrated with OCT at 3 months and 24 months. Both absolute change and percentage change will be analysed.
- • Changes in semi-quantitative grading of cataract at 3 months and 24 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00167518
|Australia, New South Wales|
|Save Sight Institute, Sydney/Sydney Eye Hospital Campus, University of Sydney|
|Sydney, New South Wales, Australia, 2000|
|Principal Investigator:||Mark C Gillies, MBBS, PhD||Save Sight Institute, Deaprtment of Clinical Ophthalmology, University of Sydney|