A Multicentre Randomised Clinical Trial of Laser Treatment Plus Intravitreal Triamcinolone for Diabetic Macular Oedema

June 21, 2010 updated by: University of Sydney

Phase II/III Multicentre Randomised Clinical Trial of Laser Treatment Plus 4 mg Intravitreal Triamcinolone Injection to Reduce Diabetic Macular Oedema

This study is likely to identify an improved and economical treatment for diabetic macular oedema, one of the commonest causes of blindness both in Australia and the rest of the world.The specific aims of the study are to test the following hypotheses:

  • That intravitreal triamcinolone followed by laser treatment results in a greater improvement in visual acuity than placebo followed by laser treatment of eyes with macular oedema secondary to diabetes;
  • That intravitreal triamcinolone followed by laser treatment results in greater degree of resolution of macular oedema than placebo followed by laser treatment of eyes with macular oedema secondary to diabetes;
  • That intravitreal triamcinolone followed by laser treatment results in a reduced requirement for further laser treatment to control diabetic macular oedema than placebo followed by laser treatment;
  • That intravitreal triamcinolone followed laser has a manageable and acceptable safety profile in eyes with diabetic macular edema.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A 25 fold increase in the risk of going blind on diagnosis of diabetes is one of the most daunting threats that people with diabetes face. Stimulated by several uncontrolled, anecdotal reports, we are already conducting a randomized clinical trial of intravitreal triamcinolone for the treatment of diabetic macular edema which is refractory to conventional laser treatment. The analysis of the 3 month data from this study has already unequivocally demonstrated that the treatment very significantly reduces or eliminates macular oedema in the short term and results in improved visual acuity. Thus intravitreal triamcinolone may represent the most significant development in the prevention of blindness in people with diabetes since the introduction of laser treatment. It is also a highly cost-effective intervention that can be administered by general ophthalmologists. The next question to be answered, which will be addressed directly by the present study, is whether there is a significant, synergistic beneficial effect when intravitreal steroids are combined with current therapy (laser).

This study represents the second major project to be undertaken by the Australian Retinal Collaboration (ARC). The ARC aims to set the highest attainable standards for investigator-initiated clinical research in retinal diseases in Australia. Having enrolled and treated more than the target of 120 patients, we are currently completing an RCT of laser induced chorioretinal anastomosis for central retinal vein occlusion, an innovative Australian concept for a severe and otherwise untreatable disease. The proposed study is likely to identify an improved and economical treatment for one of the commonest causes of blindness both in Australia and the rest of the world. Intravitreal triamcinolone is also an intervention which has generated intense interest internationally, and one for which members of the ARC are acknowledged pioneers.

Successful implementation of the study proposed, which is feasible, is highly likely to have an immediate and direct effect on the prevention of vision impairment and blindness in people with diabetes

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >= 18 years
  • Diagnosis of diabetes mellitus types 1 or 2
  • Diabetic macular oedema affecting the fovea in one or both eyes (phakic or pseudophakic) for which laser treatment is indicated in the opinion of the investigator
  • Best corrected visual acuity of 19-68 letters (6/12 -6/120)
  • Definite macular oedema on clinical examination involving the centre of the macula
  • Retinal thickness > 250 micron in central 1mm subfield on OCT
  • Investigator is comfortable deferring macular laser treatment for 6 weeks

Exclusion Criteria:

  • Glaucoma which is uncontrolled or is controlled but with glaucomatous field defects
  • Loss of vision due to other causes (e.g. age related macular degeneration, myopic macular degeneration, retinal vein occlusion)
  • Macular oedema due to other causes including vitreous traction
  • An ocular condition that would prevent visual acuity improvement despite resolution of oedema (such as foveal atrophy)
  • Previous treatment IVTA within 6 months or with peribulbar TA within 3 months
  • Cataract surgery within the last 6 months
  • Retinal laser treatment within the last 4 months
  • High risk PDR at baseline or laser therapy cannot be delayed for 6 weeks on retina
  • History of herpes viral disease in study eye
  • Media opacity including cataract that already precludes adequate macular photography and laser treatment, or cataract that is likely to preclude an adequate view within 2 years
  • 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)
  • History of chronic renal failure requiring dialysis or renal transplant
  • Blood pressure >180/110 mmHg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of eyes showing an improvement of visual acuity by 10 letters on a LogMAR chart compared with the pre-injection level 24 months after treatment
Time Frame: 24 month
At 24 months, improvement of ≥10 LogMAR letters was seen in 15/42 (36%) eyes treated with IVTA plus laser compared with 7/42 (17%) eyes treated with laser only (p=0.047, odds ratio 2.79, 95% CI, 1.01, 7.67).
24 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of laser treatments required for the treatment of macular oedema during the course of the study.
Time Frame: 24 month
At least 1 retreatment was required in the second year of the study in 29/42 (69%) of IVTA plus laser treated eyes compared with 19/42 (45%) laser only eyes (p=0.187).
24 month
Change in retinal thickness demonstrated on optical coherence tomography (OCT)
Time Frame: 24 month
There was no difference in the mean CMT (346.8μm ± 114.9SD vs 372.6μm ± 154.2SD, comparing IVTA plus laser vs laser only, p=0.349) or mean logMAR visual acuity (56.1 ± 15.7SD vs 54.5 ± 16.1SD letters, p=0.439).
24 month
The incidence of moderate or severe side effects related to the procedure of intravitreal injection or related to the drug
Time Frame: 24 month
Cataracts were removed from 17/28 (61%) of phakic IVTA plus laser-treated eyes vs. 0/27 (0%) laser only eyes (p<0.001). Treatment for elevated intraocular pressure was required in 27/42 (64%) of the IVTA plus laser eyes compared with 10/42 (24%) laser only eyes (p<0.001)
24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sydney

Collaborators

University of Melbourne
The University of Western Australia
Marsden Eye Specialists

Investigators

  • Principal Investigator: Mark C Gillies, MBBS, PhD, Save Sight Institute, Deaprtment of Clinical Ophthalmology, University of Sydney
  • Principal Investigator: Ian L McAllister, MBBS, Lions Eye Institute, The University of Western Australia
  • Principal Investigator: Tien Wong, MBBS, PhD, Royal Victoria Eye & Ear Hospital, Department of Ophthalmology, University of Melbourne
  • Principal Investigator: Jennifer Arnold, MBBS, Marsden Eye Centre Parramatta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 7, 2005

Study Record Updates

Last Update Posted (Estimate)

June 23, 2010

Last Update Submitted That Met QC Criteria

June 21, 2010

Last Verified

November 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHMRC project 352312

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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