A Multicentre Randomised Clinical Trial of Laser Treatment Plus Intravitreal Triamcinolone for Diabetic Macular Oedema
Information source: University of Sydney
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Macular Oedema
Intervention: Triamcinolone acetate (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: University of Sydney Official(s) and/or principal investigator(s): Mark C Gillies, MBBS, PhD, Principal Investigator, Affiliation: Save Sight Institute, Deaprtment of Clinical Ophthalmology, University of Sydney Ian L McAllister, MBBS, Principal Investigator, Affiliation: Lions Eye Institute, The University of Western Australia Tien Wong, MBBS, PhD, Principal Investigator, Affiliation: Royal Victoria Eye & Ear Hospital, Department of Ophthalmology, University of Melbourne Jennifer Arnold, MBBS, Principal Investigator, Affiliation: Marsden Eye Centre Parramatta
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.
Clinical Details
Official title: Phase II/III Multicentre Randomised Clinical Trial of Laser Treatment Plus 4 mg Intravitreal Triamcinolone Injection to Reduce Diabetic Macular Oedema
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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
Secondary outcome: Number of laser treatments required for the treatment of macular oedema during the course of the study.Change in retinal thickness demonstrated on optical coherence tomography (OCT) The incidence of moderate or severe side effects related to the procedure of intravitreal injection or related to the drug
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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Save Sight Institute, Sydney/Sydney Eye Hospital Campus, University of Sydney, Sydney, New South Wales 2000, Australia
Additional Information
Related publications: 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. 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.
Starting date: April 2005
Last updated: June 21, 2010
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