None listed
Conditions
Brief summary
Each study sites will apply for their own ethics approval from their local ethics committee. All study sites have been granted approval.
Interventions
The purpose of this study is to conduct a prospective, multicentre, randomised, double-masked, placebo-controlled, clinical trial of intravitreal triamcinolone (IVTA) plus laser treatment versus laser treatment alone for diabetic macular edema, to determine whether intravitreal steroids will be beneficial if they are used earlier in the course of DMO in conjunction with laser treatment.
we propose that pretreatment with intravitreal triamcinolone of an eye with macular oedema will allow laser tr
The purpose of this study is to conduct a prospective, multicentre, randomised, double-masked, placebo-controlled, clinical trial of intravitreal triamcinolone (IVTA) plus laser treatment versus laser treatment alone for diabetic macular edema, to determine whether intravitreal steroids will be beneficial if they are used earlier in the course of DMO in conjunction with laser treatment. we propose that pretreatment with intravitreal triamcinolone of an eye with macular oedema will allow laser treatment to be applied more accurately and with lower power, resulting in greater reduction of oedema and better visual outcomes. Laser treatment after the instillation of the triamcinolone will also reduce the risk of the oedema recurring as the steroid wears off. Study treatment with intravitreal triamcinolone or placebo will be administered within one week of the baseline angiogram and OCT and on the day of the baseline visual acuity measurement. Triamcinolone (0.1 ml Kenacort 40, 40mg/ml triamcinolone acetate, Bristol-Myers Squibb pharmaceuticals, Australia) will be injected into the vitreous. All eyes will receive laser treatment according to a standardised protocol 6 weeks after the injection of triamcinolone or placebo based on the distribution of the leak that was demonstrated by the baseline fluorescein angiogram. Treatment will be applied irrespective of whether the macular oedema is still present or not. The duration of the patient follow-up is 2 years and the duration of the entire study is 3.5 years.
Sponsors
Associate Professor Mark C Gillies
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosis of diabetes mellitus types 1 or 2Diabetic 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)Retinal thickness > 250 micron in central 1mm subfield on OCTInvestigator is comfortable deferring macular laser treatment for 6 weeksIntraocular pressure <22mmHg
Exclusion criteria
Glaucoma which is uncontrolled or is controlled but with more than one medication or with only one medication and 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 tractionAn ocular condition that would prevent visual acuity improvement despite resolution of oedema (such as foveal atrophy)Treatment with IVTA within the last 6 months or peribulbar TA within the last 3 months.Cataract surgery within the last 6 monthsRetinal laser treatment within the last 4 monthsHistory of pars plana vitrectomy or retinal detachment surgeryHigh risk proliferative diabetic retinopathy at baseline visit that laser cannot be delayed for 6 week on retinaHistory of herpes viral disease in study eyeMedia opacity including cataract that already precludes adequate macular photography and laser treatment, or cataract that is likely to require surgery within 2 yearsKnown allergies to triamcinolone acetatePatient is already receiving systemic steroid treatmentIntercurrent 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 transplantBlood pressure >180/110.
Outcome results
None listed