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

NCT00148265 | Completed Phase 2 DMC

• 1 other identifier: NHMRC project 352312
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Macular Oedema

Keywords

Diabetic macular oedema; Triamcinolone acetate; Intravitreal injection; Clinical trial; Laser treatment

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (3)

• Number of laser treatments required for the treatment of macular oedema during the course of the study.

  24 month

• Change in retinal thickness demonstrated on optical coherence tomography (OCT)

  24 month

• The incidence of moderate or severe side effects related to the procedure of intravitreal injection or related to the drug

  24 month

Interventions

Triamcinolone acetate DRUG

Eyes assigned to IVTA received an intravitreal injection of 0.1 ml of Kenacort 40© \[40mg/ml triamcinolone acetonide, Bristol-Myers Squibb pharmaceuticals, Australia\] on the day of the baseline visual acuity measurement under sterile conditions in a minor procedures area as an outpatient procedure. Eyes assigned to placebo were prepared in the same way but had the barrel of the syringe without a needle pushed firmly against the eye to simulate an injection.

Also known as: Kenacort 40©

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sydney: lead
• The University of Western Australia: collaborator
• University of Melbourne: collaborator
• Marsden Eye Specialists: collaborator

Study Sites (1)

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

Sydney, New South Wales, 2000, Australia

Location

Related Publications (6)

• 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.

  PMID: 15522370 BACKGROUND

• 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.

  PMID: 15860283 BACKGROUND

• 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.

  PMID: 18599569 RESULT

• Mohamed Q, Gillies MC, Wong TY. Management of diabetic retinopathy: a systematic review. JAMA. 2007 Aug 22;298(8):902-16. doi: 10.1001/jama.298.8.902.

  PMID: 17712074 RESULT

• 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 Oct;91(10):1323-6. doi: 10.1136/bjo.2006.113167. Epub 2007 Apr 3.

  PMID: 17405800 RESULT

• Gillies MC, McAllister IL, Zhu M, Wong W, Louis D, Arnold JJ, Wong TY. Pretreatment with intravitreal triamcinolone before laser for diabetic macular edema: 6-month results of a randomized, placebo-controlled trial. Invest Ophthalmol Vis Sci. 2010 May;51(5):2322-8. doi: 10.1167/iovs.09-4400. Epub 2009 Dec 17.

  PMID: 20019369 RESULT

MeSH Terms

Interventions

Triamcinolone; Triamcinolone Acetonide

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 7, 2005
• Study Start: April 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: June 23, 2010

Record last verified: 2005-11

Locations

AU (1)