Diabetic Macular OedemaPhase 2/3NCT00167518
Intravitreal Triamcinolone for Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment (TDMO)
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
The trial will test the hypothesis that an intravitreal injection of triamcinolone is safe and efficacious for patients with clinically significant diabetic macular oedema that is recalcitrant to conventional laser therapy 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
- How many people
- 70 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2002to Apr 2005
- 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
- Clinically significant diabetic macular oedema involving the fovea in one or both eyes (phakic and/or pseudophakic) which persists at least 3 months after adequate macular photocoagulation.
- best corrected visual acuity in the affected eye(s) 6/9 or worse
Who cannot join
- Glaucoma which is uncontrolled or is controlled but with glaucomatous visual field defects
- Loss of vision due to other causes (e.g. age related macular degeneration, myopic macular degeneration)
- Significant macular ischemia (FFA)
- No useful vision in fellow eye
- Known allergies to triamcinolone acetate or steroids
- Patient is already under systemic treatment with > 5mg prednisolone (or equivalent) daily.
- Intercurrent severe disease such as septicaemia
- Any condition which would affect follow-up or photographic documentation (e.g. geographical, psycho-social, media opacities)
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 Intravitreal Triamcinolone for Treatment of Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment
The trial will test the hypothesis that an intravitreal injection of triamcinolone is safe and efficacious for patients with clinically significant diabetic macular oedema that is recalcitrant to conventional laser therapy
Read the detailed description
Diabetic retinopathy is a common cause of severe loss of visual and the most common cause of legal blindness in individuals between the ages of 20 and 65 years in developed countries. Swelling of the central retina, or "macular oedema" is the commonest cause of visual loss in diabetic retinopathy.
Diabetic macular oedema is treated with laser coagulation to the macular area according to established guidelines which take into account the extent of the leak and its proximity to the centre of the macula, the "fovea". This treatment does not, however, always work and is inherently destructive.
Intravitreal injection of crystalline steroids has been proposed as a new modality to treat clinically significant diabetic macular oedema.
To determine by means of a prospective, double-masked, randomised, placebo-controlled trial to determine whether an intravitreal injection of triamcinolone three months or more after focal or grid laser photocoagulation for clinically significant diabetic macular oedema will improve the visual acuity of eligible eyes. OCT will be used in addition to visual acuity testing as an objective measurement of macular oedema.
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
• Proportion of treated versus untreated eyes with improvement of visual acuity by 5 letters or more on the ETDRS chart at 24 months, no less than 3 months after the most recent treatment episode. An interim analysis of the primary and secondary outcome
• Incidence of moderate or severe adverse effects related to treatment
Secondary outcomes (3)
• Any change of visual acuity (treated versus untreated eyes) at 3 months and 24 months after treatment
• Proportion of treated versus untreated eyes with reduction of macular thickness as demonstrated with OCT at 3 months and 24 months. Both absolute change and percentage change will be analysed.
• Changes in semi-quantitative grading of cataract at 3 months and 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startMar 2002
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Double blind
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Investigators
- Mark C Gillies, MBBS, PhD, Principal investigator, Save Sight Institute, Deaprtment of Clinical Ophthalmology, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167518
- Sponsor's protocol ID
- JDRF 1-2003-767
- Other IDs
- ORIA Esme Anderson Grant, Sydney Eye Hospital Foundation
- Status last verified
- Jan 2005
- First submitted
- 5 Sep 2005
- Last updated
- 14 Sep 2005
- Results posted
- No
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 15860283Rittiphairoj T, Mir TA, Li T, Virgili G. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2020 Nov 17;11(11):CD005656. doi: 10.1002/14651858.CD005656.pub3.
PubMed 33206392O'Day RF, Barthelmes D, Zhu M, Wong TY, McAllister IL, Arnold JJ, Gillies MC. Intraocular pressure rise is predictive of vision improvement after intravitreal triamcinolone acetonide for diabetic macular oedema: a retrospective analysis of data from a randomised controlled trial. BMC Ophthalmol. 2014 Oct 21;14:123. doi: 10.1186/1471-2415-14-123.
PubMed 25335434
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II/III Intravitreal Triamcinolone for Treatment of Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment
- ClinicalTrials.gov ID
- NCT00167518
- Acronym / sponsor ID
- JDRF 1-2003-767
- 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
- 70 participants
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Study start
- Mar 2002
- Study completion
- Apr 2005
- First posted
- 14 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.
The trial will test the hypothesis that an intravitreal injection of triamcinolone is safe and efficacious for patients with clinically significant diabetic macular oedema that is recalcitrant to conventional laser therapy
Detailed description
Diabetic retinopathy is a common cause of severe loss of visual and the most common cause of legal blindness in individuals between the ages of 20 and 65 years in developed countries. Swelling of the central retina, or "macular oedema" is the commonest cause of visual loss in diabetic retinopathy.
Diabetic macular oedema is treated with laser coagulation to the macular area according to established guidelines which take into account the extent of the leak and its proximity to the centre of the macula, the "fovea". This treatment does not, however, always work and is inherently destructive.
Intravitreal injection of crystalline steroids has been proposed as a new modality to treat clinically significant diabetic macular oedema.
To determine by means of a prospective, double-masked, randomised, placebo-controlled trial to determine whether an intravitreal injection of triamcinolone three months or more after focal or grid laser photocoagulation for clinically significant diabetic macular oedema will improve the visual acuity of eligible eyes. OCT will be used in addition to visual acuity testing as an objective measurement of macular oedema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinically significant diabetic macular oedema involving the fovea in one or both eyes (phakic and/or pseudophakic) which persists at least 3 months after adequate macular photocoagulation.
- best corrected visual acuity in the affected eye(s) 6/9 or worse
Key exclusion criteria (8 listed)
- Glaucoma which is uncontrolled or is controlled but with glaucomatous visual field defects
- Loss of vision due to other causes (e.g. age related macular degeneration, myopic macular degeneration)
- Significant macular ischemia (FFA)
- No useful vision in fellow eye
- Known allergies to triamcinolone acetate or steroids
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 acetate | Drug | – |
Primary outcome
• Proportion of treated versus untreated eyes with improvement of visual acuity by 5 letters or more on the ETDRS chart at 24 months, no less than 3 months after the most recent treatment episode. An interim analysis of the primary and secondary outcome
• Incidence of moderate or severe adverse effects related to treatment
3 secondary outcomes
• Any change of visual acuity (treated versus untreated eyes) at 3 months and 24 months after treatment
• Proportion of treated versus untreated eyes with reduction of macular thickness as demonstrated with OCT at 3 months and 24 months. Both absolute change and percentage change will be analysed.
• Changes in semi-quantitative grading of cataract at 3 months and 24 months.
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 14 Sep 2005.
- Results publication: 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.
- Results publication: 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.
- Derived from this study: PubMed 33206392Rittiphairoj T, Mir TA, Li T, Virgili G. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2020 Nov 17;11(11):CD005656. doi: 10.1002/14651858.CD005656.pub3.
- Derived from this study: PubMed 25335434O'Day RF, Barthelmes D, Zhu M, Wong TY, McAllister IL, Arnold JJ, Gillies MC. Intraocular pressure rise is predictive of vision improvement after intravitreal triamcinolone acetonide for diabetic macular oedema: a retrospective analysis of data from a randomised controlled trial. BMC Ophthalmol. 2014 Oct 21;14:123. doi: 10.1186/1471-2415-14-123.
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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
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 2 inclusion and 8 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 14 Sep 2005. 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?
• Proportion of treated versus untreated eyes with improvement of visual acuity by 5 letters or more on the ETDRS chart at 24 months, no less than 3 months after the most recent treatment episode. An interim analysis of the primary and secondary outcome. The study lists 2 primary outcomes in all. 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 NCT00167518, which also lists 4 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 14 Sep 2005.