Diabetic Macular EdemaPhase 1/2NCT00801450
Intravitreal Injection Versus Sub-Tenon's Infusion of Triamcinolone Acetonide for Refractory Diabetic Macular Edema During Cataract Surgery
A Phase 1/2 study testing Triamcinolone acetonide in people with Diabetic Macular Edema, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Triamcinolone has already been used by different routes of administration to treat diabetic macular edema. In the present study, intravitreal injection (IVI) and posterior sub-Tenon's infusion (STI) of triamcinolone acetonide (TA) during phacoemulsification cataract surgery in eyes with refractory diffuse diabetic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Triamcinolone acetonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2007to Feb 2009
- Phase
- Phase 1/2
- 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
- Refractory diffuse DME unresponsive to focal laser photocoagulation
- Best corrected visual acuity between 20/800 and 20/40; Central subfield macular thickness greater than 300 µm
Who cannot join
- Previous ocular surgery
- Glycosylated hemoglobin (Hb A1C) rate above 10%
- History of glaucoma or ocular hypertension
- Loss of vision as a result of other causes
- Systemic corticoid therapy
- Severe systemic disease
- Any condition affecting follow-up or documentation
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, 14049-900
About this study
Triamcinolone has already been used by different routes of administration to treat diabetic macular edema. In the present study, intravitreal injection (IVI) and posterior sub-Tenon's infusion (STI) of triamcinolone acetonide (TA) during phacoemulsification cataract surgery in eyes with refractory diffuse diabetic macular edema are tested.
- Conditions
- Diabetic Macular Edema
- Being tested
- Triamcinolone acetonide
- Keywords
- diabetes, macular edema, triamcinolone, cataract, refractory diabetic macular edema
- Medical subject headings
- Diabetes Mellitus, Macular Edema, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone acetonideDrug
4 mg
Triamcinolone acetonideDrug
40 mg
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal (IVI) | Experimental | Not described Receives: Drug: Triamcinolone acetonide |
| SubTenon´s (STI) | Experimental | Not described Receives: Drug: Triamcinolone acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
central subfield macular thickness
Measured: baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively
Secondary outcomes (2)
Best Corrected Visual Acuity
Measured: baseline and at 2, 4, 8±1, 12±2 and 24±2 weeks postoperatively
Intraocular pressure
Measured: baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startSep 2007
- Primary completionDec 2008 (estimated)
- Study completionFeb 2009 (estimated)
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 EdemaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801450
- Sponsor's protocol ID
- 2995/2007
- Status last verified
- Oct 2009
- First submitted
- 2 Dec 2008
- Last updated
- 12 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kumar V, Ghosh B, Raina UK, Goel N. Comparative therapy evaluation of intravitreal bevacizumab and triamcinolone acetonide on persistent diffuse diabetic macular edema. Am J Ophthalmol. 2008 Dec;146(6):974; author reply 974-5. doi: 10.1016/j.ajo.2008.08.013. No abstract available.
PubMed 19027427Audren F, Lecleire-Collet A, Erginay A, Haouchine B, Benosman R, Bergmann JF, Gaudric A, Massin P. Intravitreal triamcinolone acetonide for diffuse diabetic macular edema: phase 2 trial comparing 4 mg vs 2 mg. Am J Ophthalmol. 2006 Nov;142(5):794-99. doi: 10.1016/j.ajo.2006.06.011. Epub 2006 Sep 15.
PubMed 16978576Bonini-Filho MA, Jorge R, Barbosa JC, Calucci D, Cardillo JA, Costa RA. Intravitreal injection versus sub-Tenon's infusion of triamcinolone acetonide for refractory diabetic macular edema: a randomized clinical trial. Invest Ophthalmol Vis Sci. 2005 Oct;46(10):3845-9. doi: 10.1167/iovs.05-0297.
PubMed 16186372Paccola L, Costa RA, Folgosa MS, Barbosa JC, Scott IU, Jorge R. Intravitreal triamcinolone versus bevacizumab for treatment of refractory diabetic macular oedema (IBEME study). Br J Ophthalmol. 2008 Jan;92(1):76-80. doi: 10.1136/bjo.2007.129122. Epub 2007 Oct 26.
PubMed 17965109
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Injection Versus Sub-Tenon's Infusion of Triamcinolone Acetonide for Refractory Diabetic Macular Edema During Cataract Surgery
- ClinicalTrials.gov ID
- NCT00801450
- Acronym / sponsor ID
- 2995/2007
- Conditions
- Diabetic Macular Edema
- Keywords
- diabetes, macular edema, triamcinolone, cataract, refractory diabetic macular edema
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Sep 2007
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Feb 2009 (estimated)
- First posted
- 3 Dec 2008 (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.
Triamcinolone has already been used by different routes of administration to treat diabetic macular edema. In the present study, intravitreal injection (IVI) and posterior sub-Tenon's infusion (STI) of triamcinolone acetonide (TA) during phacoemulsification cataract surgery in eyes with refractory diffuse diabetic macular edema are tested.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravitreal (IVI) | Experimental | Drug: Triamcinolone acetonide |
| SubTenon´s (STI) | Experimental | Drug: Triamcinolone acetonide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Refractory diffuse DME unresponsive to focal laser photocoagulation
- Best corrected visual acuity between 20/800 and 20/40; Central subfield macular thickness greater than 300 µm
Key exclusion criteria (7 listed)
- Previous ocular surgery
- Glycosylated hemoglobin (Hb A1C) rate above 10%
- History of glaucoma or ocular hypertension
- Loss of vision as a result of other causes
- Systemic corticoid therapy
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 acetonide4 mg | Drug | Intravitreal (IVI) |
| Triamcinolone acetonide40 mg | Drug | SubTenon´s (STI) |
Primary outcome
central subfield macular thickness
Time frame: baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively
2 secondary outcomes
Best Corrected Visual Acuity
Time frame: baseline and at 2, 4, 8±1, 12±2 and 24±2 weeks postoperatively
Intraocular pressure
Time frame: baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2009.
- Background: PubMed 19027427Kumar V, Ghosh B, Raina UK, Goel N. Comparative therapy evaluation of intravitreal bevacizumab and triamcinolone acetonide on persistent diffuse diabetic macular edema. Am J Ophthalmol. 2008 Dec;146(6):974; author reply 974-5. doi: 10.1016/j.ajo.2008.08.013. No abstract available.
- Background: PubMed 16978576Audren F, Lecleire-Collet A, Erginay A, Haouchine B, Benosman R, Bergmann JF, Gaudric A, Massin P. Intravitreal triamcinolone acetonide for diffuse diabetic macular edema: phase 2 trial comparing 4 mg vs 2 mg. Am J Ophthalmol. 2006 Nov;142(5):794-99. doi: 10.1016/j.ajo.2006.06.011. Epub 2006 Sep 15.
- Background: PubMed 16186372Bonini-Filho MA, Jorge R, Barbosa JC, Calucci D, Cardillo JA, Costa RA. Intravitreal injection versus sub-Tenon's infusion of triamcinolone acetonide for refractory diabetic macular edema: a randomized clinical trial. Invest Ophthalmol Vis Sci. 2005 Oct;46(10):3845-9. doi: 10.1167/iovs.05-0297.
- Background: PubMed 17965109Paccola L, Costa RA, Folgosa MS, Barbosa JC, Scott IU, Jorge R. Intravitreal triamcinolone versus bevacizumab for treatment of refractory diabetic macular oedema (IBEME study). Br J Ophthalmol. 2008 Jan;92(1):76-80. doi: 10.1136/bjo.2007.129122. Epub 2007 Oct 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Triamcinolone acetonide in people with Diabetic Macular Edema, run by University of Sao Paulo at 1 site in Brazil.
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 7 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: status not confirmed, as of the sponsor's last update on 12 Oct 2009. 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 Brazil. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
central subfield macular thickness (time frame: baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively). 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 NCT00801450, 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 12 Oct 2009.