Diabetic Macular EdemaIBeTANCT02310295
Prospective, Randomized Clinical Trial Comparing Macular Photocoagulation With or Without Intravitreal Bevacizumab or Triamcinolone for the Treatment of Diabetic Macular Edema
A study testing Laser, Bevacizumab and Triamcinolone Acetonide in people with Diabetic Macular Edema, run by University of Sao Paulo.
Trial summary
Purpose: To compare the effects of macular photocoagulation with or without intravitreal bevacizumab (IVB) or triamcinolone (IVTA) for the treatment of diabetic macular edema (DME). 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?
- Laser, Bevacizumab and Triamcinolone Acetonide
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Dec 2012
- Phase
- Interventional
- 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 edema (DME) with diffuse leakage involving the center of the fovea, with DME greater than 275 microns in OCT examination
- BCVA between 0.3 LogMAR (logarithm of smaller angle of visual resolution) (20/40) and 1.6 LogMAR (20/800)
- signed of inform Consent.
Who cannot join
- HbA1c levels greater than 10%
- thromboembolic event history (including myocardial infarction and stroke)
- vitreo-macular traction on OCT
- coagulation disorders
- macular ischemia on fluorescein angiography examination
- proliferative diabetic retinopathy that required treatment
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- eye surgery
- history of ocular hypertension or glaucoma
- any ocular pathology which in the opinion of the investigator, could macular edema or change the visual acuity during the study period (for example, retinal vascular occlusion, uveitis or other inflammatory eye disease, neovascular glaucoma)
- systemic corticosteroid therapy
- any conditions that could affect the documentation
- any previous treatment for diabetic macular edema.
About this study
Official title: Bevacizumabe e Acetato de Triancinolona Intra-vítreo Associados à Laserterapia em Pacientes Com Edema Macular diabético (IBeTA)
Purpose: To compare the effects of macular photocoagulation with or without intravitreal bevacizumab (IVB) or triamcinolone (IVTA) for the treatment of diabetic macular edema (DME). Casuistic and Methods: 58 eyes of 44 patients with diffuse DME were randomized to receive either IVB + focal/grid laser (IVB-Laser, n=19), IVTA + focal/grid laser (IVTA-Laser, n=16) or focal/grid laser alone (Laser, n=23). Ophthalmic evaluation, including best-corrected visual acuity (BCVA), intraocular pressure (IOP) and central macular thickness (CMT) were performed at baseline and monthly for 12 months.
- Conditions
- Diabetic Macular Edema
- Being tested
- Laser, Bevacizumab, Triamcinolone Acetonide
- Keywords
- Diabetic retinopathy, Macular edema, Anti-VEGF, Triamcinolone
- Medical subject headings
- Diabetic Retinopathy, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaserDevice
focal macular laser therapy
BevacizumabDrug
Intravitreal injection of Bevacizumab
Triamcinolone AcetonideDrug
Intravitreal injection of Triamcinolone Acetonide
| Study group | Role | What they receive |
|---|---|---|
| IVB-Laser | Active comparator | Intravitreal Bevacizumab combined with focal laser therapy Receives: Device: Laser; Drug: Bevacizumab |
| IVTA-Laser | Active comparator | Intravitreal Triamcinolone combined with focal laser therapy Receives: Device: Laser; Drug: Triamcinolone Acetonide |
| Laser | Active comparator | focal laser therapy Receives: Device: Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central subfield macular thickness
retinal thickness measured with optical coherence tomography
Measured: 12 months
Visual acuity
Best corrected visual acuity
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startJan 2009
- Primary completionDec 2011
- Study completionDec 2012
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Messias, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310295
- Sponsor's protocol ID
- 12029-2008
- Acronym
- IBeTA
- Status last verified
- Dec 2014
- First submitted
- 2 Dec 2014
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bevacizumabe e Acetato de Triancinolona Intra-vítreo Associados à Laserterapia em Pacientes Com Edema Macular diabético (IBeTA)
- ClinicalTrials.gov ID
- NCT02310295
- Acronym / sponsor ID
- IBeTA / 12029-2008
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic retinopathy, Macular edema, Anti-VEGF, Triamcinolone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Dec 2014 (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.
Purpose: To compare the effects of macular photocoagulation with or without intravitreal bevacizumab (IVB) or triamcinolone (IVTA) for the treatment of diabetic macular edema (DME). Casuistic and Methods: 58 eyes of 44 patients with diffuse DME were randomized to receive either IVB + focal/grid laser (IVB-Laser, n=19), IVTA + focal/grid laser (IVTA-Laser, n=16) or focal/grid laser alone (Laser, n=23). Ophthalmic evaluation, including best-corrected visual acuity (BCVA), intraocular pressure (IOP) and central macular thickness (CMT) were performed at baseline and monthly for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IVB-Laser | Active comparator | Device: Laser, Drug: BevacizumabIntravitreal Bevacizumab combined with focal laser therapy |
| IVTA-Laser | Active comparator | Device: Laser, Drug: Triamcinolone AcetonideIntravitreal Triamcinolone combined with focal laser therapy |
| Laser | Active comparator | Device: Laserfocal laser therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinically significant diabetic macular edema (DME) with diffuse leakage involving the center of the fovea, with DME greater than 275 microns in OCT examination
- BCVA between 0.3 LogMAR (logarithm of smaller angle of visual resolution) (20/40) and 1.6 LogMAR (20/800)
- signed of inform Consent.
Key exclusion criteria (12 listed)
- HbA1c levels greater than 10%
- thromboembolic event history (including myocardial infarction and stroke)
- vitreo-macular traction on OCT
- coagulation disorders
- macular ischemia on fluorescein angiography examination
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 |
|---|---|---|
| Laserfocal macular laser therapy | Device | IVB-Laser, IVTA-Laser, Laser |
| BevacizumabIntravitreal injection of Bevacizumab | Drug | IVB-Laser |
| Triamcinolone AcetonideIntravitreal injection of Triamcinolone Acetonide | Drug | IVTA-Laser |
Primary outcome
Central subfield macular thickness
Time frame: 12 months
retinal thickness measured with optical coherence tomography
Visual acuity
Time frame: 12 months
Best corrected visual acuity
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 8 Dec 2014.
Related trials for Diabetic Macular Edema
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A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
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Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema
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A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingObservational study
Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT)
Diabetic Macular Edema, Diabetic Retinopathy
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.
Questions about this trial
What is this clinical trial studying?
A study testing Laser, Bevacizumab and Triamcinolone Acetonide in people with Diabetic Macular Edema, run by University of Sao Paulo.
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 3 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 8 Dec 2014. 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.
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?
Central subfield macular thickness (time frame: 12 months). 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?
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 8 Dec 2014.