Intravitreal Triamcinolone for Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment (TDMO) - Full Text View

Sponsored by:	University of Sydney
Information provided by:	University of Sydney
ClinicalTrials.gov Identifier:	NCT00167518

Purpose

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

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

Further study details as provided by University of Sydney:

Primary Outcome Measures:

• 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

Secondary Outcome Measures:

• 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.

Estimated Enrollment:	70
Study Start Date:	March 2002
Estimated Study Completion Date:	April 2005

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinically significant diabetic macular oedema involving the fovea in one or both eyes (phakic and/or pseudophakic) which persists at least 3 months after adequate macular photocoagulation.
best corrected visual acuity in the affected eye(s) 6/9 or worse

Exclusion Criteria:

Glaucoma which is uncontrolled or is controlled but with glaucomatous visual field defects
Loss of vision due to other causes (e.g. age related macular degeneration, myopic macular degeneration)
Significant macular ischemia (FFA)
No useful vision in fellow eye
Known allergies to triamcinolone acetate or steroids
Patient is already under systemic treatment with > 5mg prednisolone (or equivalent) daily.
Intercurrent severe disease such as septicaemia
Any condition which would affect follow-up or photographic documentation (e.g. geographical, psycho-social, media opacities)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00167518

Locations

Australia, New South Wales
Save Sight Institute, Sydney/Sydney Eye Hospital Campus, University of Sydney
Sydney, New South Wales, Australia, 2000

Sponsors and Collaborators

University of Sydney

Investigators

Principal Investigator:

Mark C Gillies, MBBS, PhD

Save Sight Institute, Deaprtment of Clinical Ophthalmology, University of Sydney

More Information

Publications:

Sutter FK, Simpson JM, Gillies MC. Intravitreal triamcinolone for diabetic macular edema that persists after laser treatment: three-month efficacy and safety results of a prospective, randomized, double-masked, placebo-controlled clinical trial. Ophthalmology. 2004 Nov;111(11):2044-9.

Larsson J, Zhu M, Sutter F, Gillies MC. Relation between reduction of foveal thickness and visual acuity in diabetic macular edema treated with intravitreal triamcinolone. Am J Ophthalmol. 2005 May;139(5):802-6.

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

Keywords provided by University of Sydney:

Diabetic macular oedema
Triamcinolone acetate
Intravitreal injection
Clinical trial
Laser treatment

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on September 02, 2009