ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12605000244606

Ethics application status

Approved

Date submitted

22/08/2005

Date registered

31/08/2005

Date last updated

18/05/2011

Type of registration

Retrospectively registered

Titles & IDs

Public title

Open Label Extension of a Clinical Trial of Intravitreal Triamcinolone for Diabetic Macular Oedema (TDMX study)

Scientific title

An open Label Extension of the phase II/III clinical trial of intravitreal triamcinolone on the effects and safety of clinically significant diabetic macular oedema that persists after laser treatment

Universal Trial Number (UTN)

Trial acronym

TDMX study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Diabetic Macular Oedema

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Eye

Diseases / disorders of the eye

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Results from our own randomised clinical trial, combined with anecdotal reports from other groups, suggests that intravitreal triamcinolone safely improves vision and reduces swelling for up to 2 years in most eyes with diabetic macular oedema which persists or recurs despite laser treatment. There are no data on longer term efficacy and safety. We will conduct an open-label extension of a prospective, single centre, double-masked, placebo-controlled clinical trial of IVTA for diabetic macular oedema that persists or recurs after laser treatment. Sixty four of the originally enrolled 69 (93%) eyes are available to be followed. Triamcinolone (0.1 ml Kenacort 40, 40mg/ml triamcinolone acetate, Bristol-Myers Squibb pharmaceuticals, Australia) will be injected into the vitreous in eyes which have persistent macular oedema (>250 micron) AND visual acuity of 6/9 or worse. Treatment will be withheld at the investigator’s discretion if 2 previous injections have failed to significantly (50 micron) reduce macular oedema. The duration of the patient follow-up is 3 years and the duration of the entire study is 4 years.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Placebo

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Increase of >=5 letters at the 5-year study visit on a LogMAR chart compared with (a) the initial baseline level and (b) the level at the 2-year study visit.

Timepoint [1]

At baseline, 2 years and 5 years.

Primary outcome [2]

Incidence of moderate or severe adverse events over the 3 years of the open-label extension

Timepoint [2]

at baseline, 2 years and 5 years

Secondary outcome [1]

Change in macular thickness by OCT.

Timepoint [1]

up to 5 years follow up

Secondary outcome [2]

Any change in visual acuity.

Timepoint [2]

up to 5 years follow up

Secondary outcome [3]

Number of laser treatments required.

Timepoint [3]

up to 5 years follow up

Eligibility

Key inclusion criteria

All patients at the conclusion of the TDMO study. Currently we are still following 64 of the 69 (93%) eyes that were initially entered into the TDMO study that had reduced vision from diabetic macular oedema at baseline.

Minimum age

Not stated

Maximum age

Not stated

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Uncontrolled glaucoma; Loss of vision due to other causes (e.g. age related macular degeneration, myopic macular degeneration);known allergies to triamcinolone acetate; patient is already receiving systemic steroid treatment; intercurrent severe disease such as septicemia; any condition which would affect follow-up or photographic documentation (e.g. geographical, psycho-social, media opacities).

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Phase 2 / Phase 3

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

11/04/2005

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Applied for NHMRC project grant 2006 (#402573)

Address [1]

Australia

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

NHMRC project grant 402573

Address [2]

Australia

Country [2]

Australia

Primary sponsor type

Individual

Name

Professor Mark Gillies

Address

Save Sight Institute
Department of Clinical Ophthalmology and Eye Health

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

SESIAHS Northern Network Human Research Ethics Committee

Ethics committee address [1]

NSW Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/10/2004

Ethics approval number [1]

05/272

Summary

Brief summary

We will conduct an open-label extension of a prospective, single centre, double-masked, placebo-controlled clinical trial of IVTA for diabetic macular oedema that persists or recurs after laser treatment. Sixty four of the originally enrolled 69 (93%) eyes are available to be followed. The primary outcome measures will be an increase of =5 letters at the 5-year study visit on a LogMAR chart compared with (a) the initial baseline level and (b) the level at the 2-year study visit. The incidence of moderate or severe adverse events over the 3 years of the open-label extension will also be a primary outcome. Secondary outcomes will include change in macular thickness by OCT, any change in visual acuity and number of laser treatments required. Standardised protocols have been developed for intravitreal injection, macular laser treatment, refraction and measurement of visual acuity. Treatment with triamcinolone will be offered to all patients, whether they previously received placebo or active treatment, on exit from the TDMO study. IVTA will be administered in the clinic under local anaesthesia. Treatments will be given at least 6 months apart according to prospectively identified criteria that take into account the previous and current visual acuity and macular thickness measured by OCT. The safety data will be monitored 6 monthly by an independent Safety Monitoring Committee.

Trial website

Trial related presentations / publications

1. Larsson J, Kifley A, ZhuM, Want JJ, Mitchell P, Sutter FKP, Gillies MC. Rapid reduction of 
hard exudates in eyes with diabetic retinopathy after intravitreal triamcinolone - Data from a 
randomized, placebo controlled clinical trial. Acta Ophthalmologica in press, acceptance date: 
Feb 4 2008 (IF:1.458) 
2.  Gillies MC, Islam FM, Zhu M, Larsson J, Wong TY. Efficacy and safety of multiple 
intravitreal triamcinolone injections for refractory diabetic macular oedema. Br J Ophthalmol. 
2007; 91:1323-6. (IF:2.524) 
3.  Gillies MC, Sutter FK, Simpson JM, Larsson J, Ali H, Zhu M. Intravitreal triamcinolone for 
refractory diabetic macular oedema: two-year results of a double-masked, placebo-controlled, 
randomized clinical trial. Ophthalmology. 2006;113:1533-8. (IF:4.031) 
4. Gillies MC, Simpson JM, Gaston C, Hunt G, Ali H, Zhu M, Sutter FKP. 5-year results of a randomized clinical trial with open label extension of intravitreal triamcinolone for refractory diabetic macular edema. Ophthalmology, In Press accepted 16.1.09.

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Christine Gaston

Address

Save Sight Institute
Department of Clinical Ophthalmology and Eye Health
University of Sydney
Sydney/Sydney Eye Hospital Campus
GPO Box 4337
NSW 2001

Country

Australia

Phone

+61 2 93827309

Fax

+61 2 93827318

cgaston@eye.usyd.edu.au

Contact person for scientific queries

Name

Professor Mark Gillies

Address

Save Sight Institute
Department of Clinical Ophthalmology and Eye Health
University of Sydney
Sydney/Sydney Eye Hospital Campus
GPO Box 4337
NSW 2001

Country

Australia

Phone

+61 2 93827309

Fax

+61 2 93827318

mark@eye.usyd.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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No additional documents have been identified.

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