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

NCT ID: NCT00167518

Last Updated: 2005-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2005-04-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Diabetic Macular Oedema

Keywords

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Diabetic macular oedema Triamcinolone acetate Intravitreal injection Clinical trial Laser treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Triamcinolone acetate

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sydney

OTHER

Sponsor Role lead

Principal Investigators

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Mark C Gillies, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Save Sight Institute, Sydney/Sydney Eye Hospital Campus, University of Sydney

Sydney, New South Wales, Australia

Site Status

Countries

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Australia

References

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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. doi: 10.1016/j.ophtha.2004.05.025.

Reference Type RESULT
PMID: 15522370 (View on PubMed)

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. doi: 10.1016/j.ajo.2004.12.054.

Reference Type RESULT
PMID: 15860283 (View on PubMed)

Rittiphairoj T, Mir TA, Li T, Virgili G. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2020 Nov 17;11(11):CD005656. doi: 10.1002/14651858.CD005656.pub3.

Reference Type DERIVED
PMID: 33206392 (View on PubMed)

O'Day RF, Barthelmes D, Zhu M, Wong TY, McAllister IL, Arnold JJ, Gillies MC. Intraocular pressure rise is predictive of vision improvement after intravitreal triamcinolone acetonide for diabetic macular oedema: a retrospective analysis of data from a randomised controlled trial. BMC Ophthalmol. 2014 Oct 21;14:123. doi: 10.1186/1471-2415-14-123.

Reference Type DERIVED
PMID: 25335434 (View on PubMed)

Other Identifiers

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ORIA Esme Anderson Grant

Identifier Type: -

Identifier Source: secondary_id

Sydney Eye Hospital Foundation

Identifier Type: -

Identifier Source: secondary_id

JDRF 1-2003-767

Identifier Type: -

Identifier Source: org_study_id