MedDataX Logo

Open Label Extension of a Clinical Trial of Intravitreal Triamcinolone for Diabetic Macular Oedema-TDMX Study

NCT ID: NCT00148330

Last Updated: 2010-06-30

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2008-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This open label extension will treat all the eyes of study participants with active study medication (intravitreal triamcinolone) as well as standard laser treatment where appropriate.

The specific aims will be to test the following hypotheses:

* That intravitreal triamcinolone for diabetic macular oedema that persists or recurs after laser treatment remains efficacious over five years
* That intravitreal triamcinolone for diabetic macular oedema that persists or recurs after laser treatment retains a manageable and acceptable safety profile over five years

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A 25 fold increase in the risk of going blind on diagnosis of diabetes is one of the most daunting threats that patients face. People using insulin are particularly challenged because they are unable accurately to draw up their dose of drug. Most cases of vision impairment in diabetes are due to macular oedema that persists or recurs after laser treatment. There are now a number of uncontrolled, anecdotal reports that intravitreal triamcinolone (IVTA) is highly effective for the treatment of diabetic macular edema which is refractory to conventional laser treatment. We commenced the first placebo-controlled, double masked clinical trial of IVTA for refractory macular oedema in 2002. The 3 month results from this study provide the first scientific proof of principle that IVTA reduces macular thickness and improves vision. The two year results will be available in March 2005, but confidential interim analysis of efficacy data in September 2004 suggested that the beneficial effect of triamcinolone treatment persisted. Thus it appears that treatment with IVTA may be the most significant development for the prevention of blindness in people with diabetes since the introduction of laser treatment. It would also be a highly cost-effective intervention that could be administered by general ophthalmologists. The treatment cannot be recommended for routine use, however, until its long term efficacy and safety have been established. Since we already have a well studied group of patients who have received treatment for 2 years, we are in a unique position to extend the study in order to provide the long-term (5-year) safety and efficacy data that does not appear to be forthcoming from any other source. The completion of this study will have a direct and immediate effect on the risk of blindness in people with diabetes by allowing doctors to predict more accurately the long term effects of this promising new treatment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Macular Oedema

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Diabetic macular oedema Triamcinolone acetate Intravitreal injection Clinical trial Laser treatment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Triamcinolone acetate

When indicated, intravitreal triamcinolone (0.1 ml of Kenacort 40© \[40mg/ml triamcinolone acetonide, Bristol-Myers Squibb pharmaceuticals, Australia\]) was injected into the vitreous under sterile conditions in a minor procedures area.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Kenacort 40©

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Participation in the study will be offered to 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 study that had reduced vision from diabetic macular oedema at baseline.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Sydney

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Save Sight Institute, The University of Sudyney

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mark C Gillies, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Sydney, New South Wales, Australia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia

References

Explore related publications, articles, or registry entries linked to this study.

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 BACKGROUND
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 BACKGROUND
PMID: 15860283 (View on PubMed)

Kuo CH, Gillies MC. Role of steroids in the treatment of diabetic macular edema. Int Ophthalmol Clin. 2009 Spring;49(2):121-34. doi: 10.1097/IIO.0b013e31819fcce8. No abstract available.

Reference Type BACKGROUND
PMID: 19349792 (View on PubMed)

Gillies MC, Simpson JM, Gaston C, Hunt G, Ali H, Zhu M, Sutter F. Five-year results of a randomized trial with open-label extension of triamcinolone acetonide for refractory diabetic macular edema. Ophthalmology. 2009 Nov;116(11):2182-7. doi: 10.1016/j.ophtha.2009.04.049. Epub 2009 Oct 1.

Reference Type RESULT
PMID: 19796823 (View on PubMed)

Gillies M. Diabetic macular edema. Ophthalmology. 2009 Mar;116(3):595; author reply 596-7. doi: 10.1016/j.ophtha.2008.12.016. No abstract available.

Reference Type RESULT
PMID: 19264220 (View on PubMed)

Gillies MC, Simpson JM, Zhu M, Hunt G, Ali H, Gaston C. Intravitreal triamcinolone. Ophthalmology. 2009 Mar;116(3):591. doi: 10.1016/j.ophtha.2008.09.044. No abstract available.

Reference Type RESULT
PMID: 19264215 (View on PubMed)

Gillies MC, Sutter FK, Simpson JM, Larsson J, Ali H, Zhu M. Intravitreal triamcinolone for refractory diabetic macular edema: two-year results of a double-masked, placebo-controlled, randomized clinical trial. Ophthalmology. 2006 Sep;113(9):1533-8. doi: 10.1016/j.ophtha.2006.02.065. Epub 2006 Jul 7.

Reference Type RESULT
PMID: 16828501 (View on PubMed)

Larsson J, Kifley A, Zhu M, Wang JJ, Mitchell P, Sutter FK, Gillies MC. Rapid reduction of hard exudates in eyes with diabetic retinopathy after intravitreal triamcinolone: data from a randomized, placebo-controlled, clinical trial. Acta Ophthalmol. 2009 May;87(3):275-80. doi: 10.1111/j.1755-3768.2008.01245.x. Epub 2008 Sep 10.

Reference Type RESULT
PMID: 18785964 (View on PubMed)

Wickremasinghe SS, Rogers SL, Gillies MC, Zhu M, Wong TY. Retinal vascular caliber changes after intravitreal triamcinolone treatment for diabetic macular edema. Invest Ophthalmol Vis Sci. 2008 Nov;49(11):4707-11. doi: 10.1167/iovs.08-1678. Epub 2008 Jul 3.

Reference Type DERIVED
PMID: 18599569 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NHMRC project 402573

Identifier Type: -

Identifier Source: org_study_id