![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Sponsored by: |
University of Sydney |
---|---|
Information provided by: | University of Sydney |
ClinicalTrials.gov Identifier: | NCT00167518 |
The trial will test the hypothesis that an intravitreal injection of triamcinolone is safe and efficacious for patients with clinically significant diabetic macular oedema that is recalcitrant to conventional laser therapy
Condition | Intervention | Phase |
---|---|---|
Diabetic Macular Oedema |
Drug: Triamcinolone acetate |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II/III Intravitreal Triamcinolone for Treatment of Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment |
Estimated Enrollment: | 70 |
Study Start Date: | March 2002 |
Estimated Study Completion Date: | April 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | JDRF 1-2003-767, ORIA Esme Anderson Grant, Sydney Eye Hospital Foundation |
Study First Received: | September 5, 2005 |
Last Updated: | September 11, 2005 |
ClinicalTrials.gov Identifier: | NCT00167518 History of Changes |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Diabetic macular oedema Triamcinolone acetate Intravitreal injection Clinical trial Laser treatment |
Anti-Inflammatory Agents Immunologic Factors Hormone Antagonists Eye Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Edema Macular Degeneration Retinal Degeneration Triamcinolone diacetate |
Immunosuppressive Agents Hormones Glucocorticoids Triamcinolone hexacetonide Macular Edema Signs and Symptoms Triamcinolone Acetonide Triamcinolone Retinal Diseases |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Eye Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Edema Macular Degeneration Retinal Degeneration Enzyme Inhibitors Triamcinolone diacetate |
Immunosuppressive Agents Hormones Glucocorticoids Pharmacologic Actions Triamcinolone hexacetonide Macular Edema Signs and Symptoms Triamcinolone Acetonide Therapeutic Uses Triamcinolone Retinal Diseases |