Diabetic Macular EdemaSWITCHNCT04018833
Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema
An observational study of Diabetic Macular Edema and Diabetic Retinopathy, run by Bernardete Pessoa MD.
Trial summary
PURPOSE: To evaluate the efficacy of switching from bevacizumab to ranibizumab (Lucentis; Genentech, South San Francisco, CA) or aflibercept (Eylea; Regeneron, Tarrytown, NY) in eyes with diabetic macular edema (DME) nonresponders to bevacizumab (Avastin; Genentech, South San Francisco, CA). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetic Macular Edema, Diabetic Retinopathy
- What is being tested?
- Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS] and Aflibercept 40 MG/ML Intraocular Solution [EYLEA]
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 30 Jun 2016
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients followed on the ocular diabetes consultation of Centro Hospitalar Universitário do Porto, Portugal, with DME unresponsive or incompletly responsive to intravitreal bevacizumab (1,25 MG/0.05 ML).
Who may be able to join
- type 1 or type 2 diabetes mellitus patients
- older than 18 years
- with center-involved DME, defined as central subfield thickness (CST) of more than 300 µm on spectral-domain OCT (SD-OCT).
- nonresponsive to bevacizumab, defined as having persistent intraretinal and/or subretinal fluid on optical coherence tomography (OCT), i.e CSF>300µm after a minimum of 3 monthly injections, 4 months before switch, regardless of visual acuity (VA).
Who cannot join
- additional ocular diseases that could significantly affect the visual acuity such as:
- significant vitreoretinal interface abnormality on SD-OCT that may contribute to macular edema
- age-related macular degeneration
- retinal vascular occlusion
- central corneal opacity
- amblyopia
Show all 11Show fewer
- advanced glaucoma
- optic neuropathy
- history of ocular trauma or surgery other than uncomplicated cataract extraction
- cataract surgery within 3 months before or after bevacizumab switch
- unable to provide written informed consent.
About this study
PURPOSE: To evaluate the efficacy of switching from bevacizumab to ranibizumab (Lucentis; Genentech, South San Francisco, CA) or aflibercept (Eylea; Regeneron, Tarrytown, NY) in eyes with diabetic macular edema (DME) nonresponders to bevacizumab (Avastin; Genentech, South San Francisco, CA).
METHODS: Single-center retrospective comparative study of patients with DME unresponsive to intravitreal bevacizumab that were switched to ranibizumab or aflibercept. Best-corrected visual acuity and central foveal thickness will be analysed prior to and 3 months after the switch. OCT biomarkers will also analyzed.
A p value of 0.05 or less will be considered to be statistically significant. HYPOTHESIS: Patients will improve anatomically and functionally after switch.
- Conditions
- Diabetic Macular Edema, Diabetic Retinopathy
- Being tested
- Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS], Aflibercept 40 MG/ML Intraocular Solution [EYLEA]
- Keywords
- Diabetic Macular Edema, Bevacizumab, Ranibizumab, Aflibercept, BCVA, OCT
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]Drug
Aflibercept 40 MG/ML Intraocular Solution [EYLEA]Drug
| Study group | Role | What they receive |
|---|---|---|
| ranibizumab | Patients nonresponsive to bevacizumab that were switched to ranibizumab Receives: Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS] | |
| aflibercept | Patients nonresponsive to bevacizumab that were switched to aflibercept Receives: Drug: Aflibercept 40 MG/ML Intraocular Solution [EYLEA] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical change
The central foveal thickness (CFT), measured by Optical Coherence Tomography, was automatically measured by the software in the central 1 mm. A CFT <250 µm or >300 µm is considered pathological. A CFT between 200 and 300 µm is considered physiological. CFT has no defined minimum or maximum values.
Since patients with diabetic macular edema usually have CFT >300 µm the goal of treatment is to lower the CFT to values between 200 and 300 µm. A clinical significant anatomical improvement was considered for a change in CFT≥10%.
Measured: Immediately before switch (one month after last bevacizumab intravitreal injection); 4 months after switch. Minimum of three intravitreal injections before and after switch.
Functional change
Functional change was measure by the Early Treatment Diabetic Retinopathy Scale (ETDRS) which measures the best-corrected visual acuity with an ETDRS-like chart at 4 meters in number letters or at 1 meter when patients are unable to read any letters on the ETDRS chart at 4 meters. The ETDRS scale varies from 1 to 85 letters (85 letters correspond to a 20/20 in the Snellen scale).
The higher the value the better the outcome. A clinical significant functional improvement was considered for a gain of ≥5 EDTRS letters.
Measured: Immediately before switch (one month after last bevacizumab intravitreal injection); 4 months after switch. Minimum of three intravitreal injections before and after switch.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start1 Jan 2012
- Primary completion1 Jun 2016
- Study completion30 Jun 2016
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bernardete Pessoa MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bernardete Pessoa MD, Centro Hospitalar do Porto
- Investigators
- João Melo-Beirão, MD, PhD, Study director, Centro Hospitalar do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018833
- Sponsor's protocol ID
- 20190701245703984
- Acronym
- SWITCH
- Status last verified
- Jul 2019
- First submitted
- 10 Jul 2019
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Pessoa B, Malheiro L, Carneiro I, Monteiro S, Coelho J, Coelho C, Figueira J, Meireles A, Melo Beirao JN. Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema: Exploratory Retrospective Analysis. Clin Ophthalmol. 2021 Jan 22;15:253-260. doi: 10.2147/OPTH.S280644. eCollection 2021.
PubMed 33519187
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT04018833
- Acronym / sponsor ID
- SWITCH / 20190701245703984
- Conditions
- Diabetic Macular Edema, Diabetic Retinopathy
- Keywords
- Diabetic Macular Edema, Bevacizumab, Ranibizumab, Aflibercept, BCVA, OCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bernardete Pessoa MDUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 15 Jul 2019 (actual)
- 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 evaluate the efficacy of switching from bevacizumab to ranibizumab (Lucentis; Genentech, South San Francisco, CA) or aflibercept (Eylea; Regeneron, Tarrytown, NY) in eyes with diabetic macular edema (DME) nonresponders to bevacizumab (Avastin; Genentech, South San Francisco, CA).
METHODS: Single-center retrospective comparative study of patients with DME unresponsive to intravitreal bevacizumab that were switched to ranibizumab or aflibercept. Best-corrected visual acuity and central foveal thickness will be analysed prior to and 3 months after the switch. OCT biomarkers will also analyzed.
A p value of 0.05 or less will be considered to be statistically significant. HYPOTHESIS: Patients will improve anatomically and functionally after switch.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ranibizumab | – | Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]Patients nonresponsive to bevacizumab that were switched to ranibizumab |
| aflibercept | – | Drug: Aflibercept 40 MG/ML Intraocular Solution [EYLEA]Patients nonresponsive to bevacizumab that were switched to aflibercept |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients followed on the ocular diabetes consultation of Centro Hospitalar Universitário do Porto, Portugal, with DME unresponsive or incompletly responsive to intravitreal bevacizumab (1,25 MG/0.05 ML).
Key inclusion criteria (4 listed)
- type 1 or type 2 diabetes mellitus patients
- older than 18 years
- with center-involved DME, defined as central subfield thickness (CST) of more than 300 µm on spectral-domain OCT (SD-OCT).
- nonresponsive to bevacizumab, defined as having persistent intraretinal and/or subretinal fluid on optical coherence tomography (OCT), i.e CSF>300µm after a minimum of 3 monthly injections, 4 months before switch, regardless of visual acuity (VA).
Key exclusion criteria (11 listed)
- additional ocular diseases that could significantly affect the visual acuity such as:
- significant vitreoretinal interface abnormality on SD-OCT that may contribute to macular edema
- age-related macular degeneration
- retinal vascular occlusion
- central corneal opacity
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 |
|---|---|---|
| Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS] | Drug | ranibizumab |
| Aflibercept 40 MG/ML Intraocular Solution [EYLEA] | Drug | aflibercept |
Primary outcome
Anatomical change
Time frame: Immediately before switch (one month after last bevacizumab intravitreal injection); 4 months after switch. Minimum of three intravitreal injections before and after switch.
The central foveal thickness (CFT), measured by Optical Coherence Tomography, was automatically measured by the software in the central 1 mm. A CFT <250 µm or >300 µm is considered pathological. A CFT between 200 and 300 µm is considered physiological. CFT has no defined minimum or maximum values. Since patients with diabetic macular edema usually have CFT >300 µm the goal of treatment is to lower the CFT to values between 200 and 300 µm. A clinical significant anatomical improvement was considered for a change in CFT≥10%.
Functional change
Time frame: Immediately before switch (one month after last bevacizumab intravitreal injection); 4 months after switch. Minimum of three intravitreal injections before and after switch.
Functional change was measure by the Early Treatment Diabetic Retinopathy Scale (ETDRS) which measures the best-corrected visual acuity with an ETDRS-like chart at 4 meters in number letters or at 1 meter when patients are unable to read any letters on the ETDRS chart at 4 meters. The ETDRS scale varies from 1 to 85 letters (85 letters correspond to a 20/20 in the Snellen scale). The higher the value the better the outcome. A clinical significant functional improvement was considered for a gain of ≥5 EDTRS letters.
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 23 Jul 2019.
- Derived from this study: PubMed 33519187Pessoa B, Malheiro L, Carneiro I, Monteiro S, Coelho J, Coelho C, Figueira J, Meireles A, Melo Beirao JN. Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema: Exploratory Retrospective Analysis. Clin Ophthalmol. 2021 Jan 22;15:253-260. doi: 10.2147/OPTH.S280644. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
João Melo-Beirão, MD, PhD study director
Centro Hospitalar do Porto
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema and Diabetic Retinopathy, run by Bernardete Pessoa MD.
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 4 inclusion and 11 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 23 Jul 2019. 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?
Anatomical change (time frame: Immediately before switch (one month after last bevacizumab intravitreal injection); 4 months after switch. Minimum of three intravitreal injections before and after switch.). 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?
On the ClinicalTrials.gov record for NCT04018833, 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 23 Jul 2019; AzTrials last refreshed its copy on 8 Nov 2026.