Diabetic Macular EdemaPhase 4ATEMDNCT00737971
Efficacy Study of Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema
A Phase 4 study testing Bevacizumab intravitreal, Triamcinolone and Triamcinolone + Bevacizumab in people with Diabetic Macular Edema, run by Rubens Belfort Jr. at 1 site in Brazil.
Trial summary
Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema 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?
- Bevacizumab intravitreal, Triamcinolone and Triamcinolone + Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2008to Dec 2013
- Phase
- Phase 4
- 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
- 18 years of age at least
- Diagnosis of diabetes mellitus (type 1 or type 2. any one of the following will be considered to be sufficient evidence that diabetes is present:
- current regular use of insulin for the treatment of diabetes
- current regular use of oral hypoglycemic agents for the treatment of diabetes
- diabetes as defined by american Diabetes Association (ADA)
- symptoms of diabetes (polyuria, polydipsia, and unexplained weight loss) or eighth-hour fasting plasma glucose > 126 mg/dl
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- Diabetic macular edema clinically observable associated with diabetic retinopathy:
- without prior foveal treatment with laser therapy
- if photocoagulation or peripherical or macular laser, at least 3 months
- absence of macular ischemia by fluorescein angiography on baseline visit
- BCVA score between 20 letters (20/400 ETDRS)e 70 letters (20/40 ETDRS) in the study eye measured by the ETDRS method at qualification/baseline visit
- Retinal thickness > 275um by OCT
- One eye per patient will be chosen for the study. In case of both eye eligible, it will be chosen an eye to be treated with study medication and another eye treated with laser
- Taught hyaloid syndrome
Who cannot join
- Uncontrolled systemic disease
- Initiation of medical therapy for diabetes or a change from oral hypoglycemic agents to insulin therapy within 4 months prior to the qualification visit
- Renal failure requiring hemodialysis or peritoneal dialysis within 6 months prior to the qualification visit
- Any ocular condition in the study eye that in the opinion of the investigator would prevent a 2 lines improvement of visual acuity (e.g. severe macular ischemia)
- Presence of branch retinal vein occlusion, central retinal vein occlusion, uveitis, pseudophakic cystoid edema or any other condition in the study eye which could be contributing to macular edema
- Presence of an epiretinal membrane in the study eye
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- History of IOP elevation in response to steroid treatment in either eye
- History of glaucoma or optic nerve head change consistent with glaucoma damage
- Ocular hypertension requiring more than 1 anti-glaucoma medication to maintain IOP < 11mmhg at qualification visit
- Presence of anterior chamber intraocular lens in the study eye
- Active optic disc or retinal neovascularization in the study eye at qualification visit
- Active or history of choroidal neovascularization in the study eye
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Sao Paulo - Dept. of Ophthalmology / Vision Institute
São Paulo, São Paulo, 04040-002
About this study
Official title: A Randomized, Parallel Group, Masked Clinical Study to Evaluate the Efficacy of Triamcinolone and Bevacizumab Through Intravitreal Injection With Individual or Simultaneous Drugs to Treatment of Diabetic Macular Edema
Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema
Read the detailed description
Efficacy Study of Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema
- Conditions
- Diabetic Macular Edema
- Being tested
- Bevacizumab intravitreal, Triamcinolone, Triamcinolone + Bevacizumab
- Keywords
- avastin, bevacizumab, triamcinolone, diabetic macular edema, macular edema, intravitreal injection
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab intravitrealDrug
Also called Avastin
Bevacizumab intravitreal 0.05 ml/1.25 mg - administered on D0, Week 4, Week 8
TriamcinoloneDrug
Intravitreal 0.1 ml/4 mg, D0, Week 4 and Week 8
Triamcinolone + BevacizumabDrug
Also called triamcinolone + avastin
Intravitreal triamcinolone 0.1 ml/4 mg + bevacizumab 0.05 ml/1.25 mg simultaneously on D0, week 4, Week 8
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Avastin intravitreal injection D0, Week 4, Week 8 Receives: Drug: Bevacizumab intravitreal |
| B | Active comparator | Triamcinolone intravitreal injection Receives: Drug: Triamcinolone |
| C | Active comparator | Avastin + Triamcinolone intravitreal injection simultaneously Receives: Drug: Triamcinolone + Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of visual acuity (E Snellen)
Measured: monthly
Secondary outcomes (2)
Tonometry
Measured: monthly
Measurement of retinal thickness by OCT
Measured: monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2012
- Study completionDec 2013
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rubens Belfort Jr.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rubens Belfort Jr., Federal University of São Paulo
- Investigators
- Rubens Belfort Jr, MD, Principal investigator, Federal University of São Paulo / Dept. of OPhthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737971
- Sponsor's protocol ID
- 108/08
- Acronym
- ATEMD
- Status last verified
- Apr 2016
- First submitted
- 19 Aug 2008
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: data presented in several congresses: ARVO 2010-- poster ARVO 2011, WOC BERLIN 2010, WOC ABU DABHI 2012 (partial data) CBO 2014 (final data)
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel Group, Masked Clinical Study to Evaluate the Efficacy of Triamcinolone and Bevacizumab Through Intravitreal Injection With Individual or Simultaneous Drugs to Treatment of Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT00737971
- Acronym / sponsor ID
- ATEMD / 108/08
- Conditions
- Diabetic Macular Edema
- Keywords
- avastin, bevacizumab, triamcinolone, diabetic macular edema, macular edema, intravitreal injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Rubens Belfort Jr.University, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Aug 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 and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema
Detailed description
Efficacy Study of Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Bevacizumab intravitrealAvastin intravitreal injection D0, Week 4, Week 8 |
| B | Active comparator | Drug: TriamcinoloneTriamcinolone intravitreal injection |
| C | Active comparator | Drug: Triamcinolone + BevacizumabAvastin + Triamcinolone intravitreal injection simultaneously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 18 years of age at least
- Diagnosis of diabetes mellitus (type 1 or type 2. any one of the following will be considered to be sufficient evidence that diabetes is present:
- Diabetic macular edema clinically observable associated with diabetic retinopathy:
- BCVA score between 20 letters (20/400 ETDRS)e 70 letters (20/40 ETDRS) in the study eye measured by the ETDRS method at qualification/baseline visit
- Retinal thickness > 275um by OCT
Key exclusion criteria (12 listed)
- Uncontrolled systemic disease
- Initiation of medical therapy for diabetes or a change from oral hypoglycemic agents to insulin therapy within 4 months prior to the qualification visit
- Renal failure requiring hemodialysis or peritoneal dialysis within 6 months prior to the qualification visit
- Any ocular condition in the study eye that in the opinion of the investigator would prevent a 2 lines improvement of visual acuity (e.g. severe macular ischemia)
- Presence of branch retinal vein occlusion, central retinal vein occlusion, uveitis, pseudophakic cystoid edema or any other condition in the study eye which could be contributing to macular edema
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 |
|---|---|---|
| Bevacizumab intravitrealAlso: AvastinBevacizumab intravitreal 0.05 ml/1.25 mg - administered on D0, Week 4, Week 8 | Drug | A |
| TriamcinoloneIntravitreal 0.1 ml/4 mg, D0, Week 4 and Week 8 | Drug | B |
| Triamcinolone + BevacizumabAlso: triamcinolone + avastinIntravitreal triamcinolone 0.1 ml/4 mg + bevacizumab 0.05 ml/1.25 mg simultaneously on D0, week 4, Week 8 | Drug | C |
Primary outcome
Measurement of visual acuity (E Snellen)
Time frame: monthly
2 secondary outcomes
Tonometry
Time frame: monthly
Measurement of retinal thickness by OCT
Time frame: monthly
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 3 May 2016.
- Individual participant dataSharing planned: Yes. data presented in several congresses: ARVO 2010-- poster ARVO 2011, WOC BERLIN 2010, WOC ABU DABHI 2012 (partial data) CBO 2014 (final data)
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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.
Rubens Belfort Jr, MD principal investigator
Federal University of São Paulo / Dept. of OPhthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bevacizumab intravitreal, Triamcinolone and Triamcinolone + Bevacizumab in people with Diabetic Macular Edema, run by Rubens Belfort Jr. 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 14 inclusion and 12 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 3 May 2016. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Measurement of visual acuity (E Snellen) (time frame: monthly). 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 3 May 2016.