Diabetic Macular EdemaPhase 2Tribeva-DMENCT00874744
Comparison of Single Intravitreal Injection of Triamcinolone or Bevacizumab for the Treatment of Diabetic Macular Edema
A Phase 2 study testing Bevacizumab and Triamcinolone acetonide in people with Diabetic Macular Edema, run by Universidade Federal de Goias.
Trial summary
The purpose of this study is to compare a single intravitreal injection of 4.0 mg of triamcinolone acetonide and 1.25 mg of bevacizumab for the treatment of diabetic macular edema. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Bevacizumab and Triamcinolone acetonide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Oct 2008
- Phase
- Phase 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic macular edema with central foveal measurement over 300 micrometers
Who cannot join
- Glaucoma
- Vitreoretinal surgery
- Cataract Surgery less than 3 months prior inclusion
- Unilateral cataract surgery
- Uncontrolled Glycosylated Hemoglobin
- Previous Intraocular Injection
Show all 10Show fewer
- Systemic Corticosteroids less than 1 month prior inclusion
- Macular ischemia at Fluorescein Angiography
- Cataract precluding fundus examination
- Active Proliferative Diabetic Retinopathy
About this study
Official title: Phase 2 Study of Comparison of Single Intravitreal Injection of Triamcinolone or Bevacizumab for the Treatment of Diabetic Macular Edema.
The purpose of this study is to compare a single intravitreal injection of 4.0 mg of triamcinolone acetonide and 1.25 mg of bevacizumab for the treatment of diabetic macular edema.
Read the detailed description
Comparison a single intravitreal injection of 4.0 mg of triamcinolone acetonide and 1.25 mg of bevacizumab regarding the ability of central macular thickness reduction. Secondary objectives are analysis of Visual Outcomes and variations on Intraocular Pressure. The patients data were statistically analyzed if there was a 24 week follow up completed.
- Conditions
- Diabetic Macular Edema
- Being tested
- Bevacizumab, Triamcinolone acetonide
- Keywords
- Diabetic macular edema, intravitreal injection, Pharmacological treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called 1.Bevacizumab, 2.Avastin
1.25mg bevacizumab (0.05ml)
Triamcinolone acetonideDrug
Also called 1. Theracort, 2. Kenalog
4.0 mg Triamcinolone acetonide injection
| Study group | Role | What they receive |
|---|---|---|
| bevacizumab | Experimental | Not described Receives: Drug: Bevacizumab |
| Triamcinolone | Experimental | Not described Receives: Drug: Triamcinolone acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between the efficacy of a single intravitreal injection of 4.0mg of triamcinolone acetonide or 1.25mg of bevacizumab in the treatment of diabetic macular edema
Measured: 6 months
Secondary outcomes (2)
To compare Visual Acuity between the same drug in Initial visit, 4, 12 ans 24 weeks and Visual Acuity between two group of eyes treated with different drugs.
Measured: 6 months
To compare Intraocular Pressure between the same drug in Initial visit, 4, 12 ans 24 weeks and Intraocular Pressure between two group of eyes treated with different drugs.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startMar 2008
- Primary completionSep 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Goias
- Sponsor type
- University, hospital or other
- Investigators
- David LC Isaac, MD, PhD, Principal investigator, Universidade Federal de Goias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874744
- Sponsor's protocol ID
- Cerof-001
- Acronym
- Tribeva-DME
- Status last verified
- Mar 2009
- First submitted
- 31 Mar 2009
- Last updated
- 2 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Comparison of Single Intravitreal Injection of Triamcinolone or Bevacizumab for the Treatment of Diabetic Macular Edema.
- ClinicalTrials.gov ID
- NCT00874744
- Acronym / sponsor ID
- Tribeva-DME / Cerof-001
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic macular edema, intravitreal injection, Pharmacological treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Universidade Federal de GoiasUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 2 Apr 2009 (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 purpose of this study is to compare a single intravitreal injection of 4.0 mg of triamcinolone acetonide and 1.25 mg of bevacizumab for the treatment of diabetic macular edema.
Detailed description
Comparison a single intravitreal injection of 4.0 mg of triamcinolone acetonide and 1.25 mg of bevacizumab regarding the ability of central macular thickness reduction. Secondary objectives are analysis of Visual Outcomes and variations on Intraocular Pressure. The patients data were statistically analyzed if there was a 24 week follow up completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bevacizumab | Experimental | Drug: Bevacizumab |
| Triamcinolone | Experimental | Drug: Triamcinolone acetonide |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetic macular edema with central foveal measurement over 300 micrometers
Key exclusion criteria (10 listed)
- Glaucoma
- Vitreoretinal surgery
- Cataract Surgery less than 3 months prior inclusion
- Unilateral cataract surgery
- Uncontrolled Glycosylated Hemoglobin
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 |
|---|---|---|
| BevacizumabAlso: 1.Bevacizumab, 2.Avastin1.25mg bevacizumab (0.05ml) | Drug | bevacizumab |
| Triamcinolone acetonideAlso: 1. Theracort, 2. Kenalog4.0 mg Triamcinolone acetonide injection | Drug | Triamcinolone |
Primary outcome
Comparison between the efficacy of a single intravitreal injection of 4.0mg of triamcinolone acetonide or 1.25mg of bevacizumab in the treatment of diabetic macular edema
Time frame: 6 months
2 secondary outcomes
To compare Visual Acuity between the same drug in Initial visit, 4, 12 ans 24 weeks and Visual Acuity between two group of eyes treated with different drugs.
Time frame: 6 months
To compare Intraocular Pressure between the same drug in Initial visit, 4, 12 ans 24 weeks and Intraocular Pressure between two group of eyes treated with different drugs.
Time frame: 6 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 2 Apr 2009.
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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.
David LC Isaac, MD, PhD principal investigator
Universidade Federal de Goias
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab and Triamcinolone acetonide in people with Diabetic Macular Edema, run by Universidade Federal de Goias.
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 1 inclusion and 10 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 2 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
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 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.
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?
Comparison between the efficacy of a single intravitreal injection of 4.0mg of triamcinolone acetonide or 1.25mg of bevacizumab in the treatment of diabetic macular edema (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2009.