Diabetic Macular OedemaPhase 2/3NCT00148265
A Multicentre Randomised Clinical Trial of Laser Treatment Plus Intravitreal Triamcinolone for Diabetic Macular Oedema
A Phase 2/3 study testing Triamcinolone acetate in people with Diabetic Macular Oedema, run by University of Sydney at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Oedema
- What is being tested?
- Triamcinolone acetate
- Type of treatment
- Injection or infusion
- How many people
- 54 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2005to May 2009
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Save Sight Institute, Sydney/Sydney Eye Hospital Campus, University of Sydney
Sydney, New South Wales, 2000
About this study
Official title: 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.
Read the 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
- Conditions
- Diabetic Macular Oedema
- Being tested
- Triamcinolone acetate
- Keywords
- Diabetic macular oedema, Triamcinolone acetate, Intravitreal injection, Clinical trial, Laser treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone acetateDrug
Also called Kenacort 40©
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 month
Secondary outcomes (3)
Number of laser treatments required for the treatment of macular oedema during the course of the study.
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).
Measured: 24 month
Change in retinal thickness demonstrated on optical coherence tomography (OCT)
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).
Measured: 24 month
The incidence of moderate or severe side effects related to the procedure of intravitreal injection or related to the drug
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)
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetic Macular OedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Western Australia, University of Melbourne, Marsden Eye Specialists
- Investigators
- Mark C Gillies, MBBS, PhD, Principal investigator, Save Sight Institute, Deaprtment of Clinical Ophthalmology, University of SydneyIan L McAllister, MBBS, Principal investigator, Lions Eye Institute, The University of Western AustraliaTien Wong, MBBS, PhD, Principal investigator, Royal Victoria Eye & Ear Hospital, Department of Ophthalmology, University of MelbourneJennifer Arnold, MBBS, Principal investigator, Marsden Eye Centre Parramatta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148265
- Sponsor's protocol ID
- NHMRC project 352312
- Status last verified
- Nov 2005
- First submitted
- 6 Sep 2005
- Last updated
- 23 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1016/j.ophtha.2004.05.025.
PubMed 15522370Larsson 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.
PubMed 15860283Wickremasinghe 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.
PubMed 18599569Mohamed 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.
PubMed 17712074Gillies 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.
PubMed 17405800Gillies 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.
PubMed 20019369
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II/III Multicentre Randomised Clinical Trial of Laser Treatment Plus 4 mg Intravitreal Triamcinolone Injection to Reduce Diabetic Macular Oedema
- ClinicalTrials.gov ID
- NCT00148265
- Acronym / sponsor ID
- NHMRC project 352312
- Conditions
- Diabetic Macular Oedema
- Keywords
- Diabetic macular oedema, Triamcinolone acetate, Intravitreal injection, Clinical trial, Laser treatment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- The University of Western Australia, University of Melbourne, Marsden Eye Specialists
- Study start
- Apr 2005
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 7 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triamcinolone acetateAlso: Kenacort 40©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. | Drug | – |
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
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).
3 secondary outcomes
Number of laser treatments required for the treatment of macular oedema during the course of the study.
Time frame: 24 month
Change in retinal thickness demonstrated on optical coherence tomography (OCT)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2010.
- Background: PubMed 15522370Sutter 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.
- Background: PubMed 15860283Larsson 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.
- Results publication: PubMed 18599569Wickremasinghe 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.
- Results publication: PubMed 17712074Mohamed 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.
- Results publication: PubMed 17405800Gillies 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.
- Results publication: PubMed 20019369Gillies 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark C Gillies, MBBS, PhD principal investigator
Save Sight Institute, Deaprtment of Clinical Ophthalmology, University of Sydney
Ian L McAllister, MBBS principal investigator
Lions Eye Institute, The University of Western Australia
Tien Wong, MBBS, PhD principal investigator
Royal Victoria Eye & Ear Hospital, Department of Ophthalmology, University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Triamcinolone acetate in people with Diabetic Macular Oedema, run by University of Sydney at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00148265, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2010.