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

Diabetic Macular Oedema Clinical Trial

Official title:

Phase II/III Intravitreal Triamcinolone for Treatment of Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00167518
• Other study ID #: JDRF 1-2003-767
• Secondary ID: ORIA Esme Anders
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 5, 2005
• Last updated: September 11, 2005
• Start date: March 2002
• Est. completion date: April 2005

Study information

• Verified date: January 2005
• Source: University of Sydney
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Oedema
• Edema
• Macular Edema

Intervention

Drug:
• Triamcinolone acetate

Locations

Country	Name	City	State
Australia	Save Sight Institute, Sydney/Sydney Eye Hospital Campus, University of Sydney	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
University of Sydney

Country where clinical trial is conducted

Australia, 

References & Publications (2)

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. — View Citation

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. Ophthalmo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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
Primary	• Incidence of moderate or severe adverse effects related to treatment
Secondary	• Any change of visual acuity (treated versus untreated eyes) at 3 months and 24 months after treatment
Secondary	• 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.
Secondary	• Changes in semi-quantitative grading of cataract at 3 months and 24 months.