Diabetic RetinopathyPhase 2IBERA-DMENCT01487629
Bevacizumab Versus Ranibizumab for the Treatment of Diabetic Macular Edema
A Phase 2 study testing Bevacizumab and Ranibizumab in people with Diabetic Retinopathy and Macular Edema, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to compare the morphological and visual acuity outcomes associated with 1.5 mg bevacizumab versus 0.5 ranibizumab intravitreal injections for treatment of diabetic macular edema. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Retinopathy, Macular Edema
- What is being tested?
- Bevacizumab and Ranibizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2010to Sep 2012
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Center-involving Diabetic macular edema unresponsive to LASER therapy performed at least 3 moths prior to inclusion;
- Best corrected visual acuity equal or worse than 20/40 and better than 20/800;
- Central subfield macular thickness greater than 300 µm
Who cannot join
- Aphakia
- High-risk proliferative diabetic retinopathy
- Previous treatment for DME in the past three months
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP
Ribeirão Preto, São Paulo, 14048-900
About this study
Official title: Bevacizumab Versus Ranibizumab for Refractory Diabetic Macular Edema
The purpose of this study is to compare the morphological and visual acuity outcomes associated with 1.5 mg bevacizumab versus 0.5 ranibizumab intravitreal injections for treatment of diabetic macular edema.
- Conditions
- Diabetic Retinopathy, Macular Edema
- Being tested
- Bevacizumab, Ranibizumab
- Keywords
- Diabetic Retinopathy, Macular Edema, Bevacizumab, Ranibizumab
- 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.
BevacizumabDrug
Also called Avastin
Bevacizumab, 1.5 mg, intravitreal, throughout the study
RanibizumabDrug
Also called Lucentis
Ranibizumab, 0.5 mg, intravitreal, throughout the study
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab | Experimental | Treatment of macular edema with intravitreal Bevacizumab Receives: Drug: Bevacizumab |
| Ranibizumab | Experimental | Treatment of macular edema with intravitreal Ranibizumab Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central subfield macular thickness (CSFT) change
Central subfield macular thickness (CSFT) measured with spectral-domain optical coherence tomography (OCT)
Measured: Monthly from baseline to Week 48
Secondary outcomes (1)
Best-corrected visual acuity change
Best-corrected visual acuity using ETDRS charts
Measured: Monthly from baseline to week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startApr 2010
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 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
- Responsible party
- Principal investigator, Rodrigo Jorge, University of Sao Paulo
- Investigators
- Rodrigo Jorge, MD, PhD, Principal investigator, University of Sao PauloFelipe Almeida, MD, Study director, Hospital das Clinicas - Faculdade de Medicina de Ribeirão Preto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487629
- Sponsor's protocol ID
- 13368/2010
- Acronym
- IBERA-DME
- Status last verified
- Dec 2011
- First submitted
- 2 Dec 2011
- Last updated
- 13 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Nepomuceno AB, Takaki E, Paes de Almeida FP, Peroni R, Cardillo JA, Siqueira RC, Scott IU, Messias A, Jorge R. A prospective randomized trial of intravitreal bevacizumab versus ranibizumab for the management of diabetic macular edema. Am J Ophthalmol. 2013 Sep;156(3):502-510.e2. doi: 10.1016/j.ajo.2013.04.026. Epub 2013 Jun 21.
PubMed 23795985
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bevacizumab Versus Ranibizumab for Refractory Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT01487629
- Acronym / sponsor ID
- IBERA-DME / 13368/2010
- Conditions
- Diabetic Retinopathy, Macular Edema
- Keywords
- Diabetic Retinopathy, Macular Edema, Bevacizumab, Ranibizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Apr 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 7 Dec 2011 (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 the morphological and visual acuity outcomes associated with 1.5 mg bevacizumab versus 0.5 ranibizumab intravitreal injections for treatment of diabetic macular edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab | Experimental | Drug: BevacizumabTreatment of macular edema with intravitreal Bevacizumab |
| Ranibizumab | Experimental | Drug: RanibizumabTreatment of macular edema with intravitreal Ranibizumab |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Center-involving Diabetic macular edema unresponsive to LASER therapy performed at least 3 moths prior to inclusion;
- Best corrected visual acuity equal or worse than 20/40 and better than 20/800;
- Central subfield macular thickness greater than 300 µm
Key exclusion criteria (3 listed)
- Aphakia
- High-risk proliferative diabetic retinopathy
- Previous treatment for DME in the past three months
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: AvastinBevacizumab, 1.5 mg, intravitreal, throughout the study | Drug | Bevacizumab |
| RanibizumabAlso: LucentisRanibizumab, 0.5 mg, intravitreal, throughout the study | Drug | Ranibizumab |
Primary outcome
Central subfield macular thickness (CSFT) change
Time frame: Monthly from baseline to Week 48
Central subfield macular thickness (CSFT) measured with spectral-domain optical coherence tomography (OCT)
1 secondary outcome
Best-corrected visual acuity change
Time frame: Monthly from baseline to week 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2011.
- Derived from this study: PubMed 23795985Nepomuceno AB, Takaki E, Paes de Almeida FP, Peroni R, Cardillo JA, Siqueira RC, Scott IU, Messias A, Jorge R. A prospective randomized trial of intravitreal bevacizumab versus ranibizumab for the management of diabetic macular edema. Am J Ophthalmol. 2013 Sep;156(3):502-510.e2. doi: 10.1016/j.ajo.2013.04.026. Epub 2013 Jun 21.
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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.
Rodrigo Jorge, MD, PhD principal investigator
University of Sao Paulo
Felipe Almeida, MD study director
Hospital das Clinicas - Faculdade de Medicina de Ribeirão Preto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab and Ranibizumab in people with Diabetic Retinopathy and 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 3 inclusion and 3 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 13 Dec 2011. 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 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 (CSFT) change (time frame: Monthly from baseline to Week 48). 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 NCT01487629, which also lists 1 linked publication.
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 13 Dec 2011.