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出境医 / 临床实验 / Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema (SWITCH)

Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema (SWITCH)

Study Description
Brief 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).

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.


Condition or disease Intervention/treatment
Diabetic Macular Edema Diabetic Retinopathy Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS] Drug: Aflibercept 40 MG/ML Intraocular Solution [EYLEA]

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema
Actual Study Start Date : January 1, 2012
Actual Primary Completion Date : June 1, 2016
Actual Study Completion Date : June 30, 2016
Arms and Interventions
Group/Cohort Intervention/treatment
ranibizumab
Patients nonresponsive to bevacizumab that were switched to ranibizumab
 Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]
aflibercept
Patients nonresponsive to bevacizumab that were switched to aflibercept
 Drug: Aflibercept 40 MG/ML Intraocular Solution [EYLEA]
Outcome Measures
Primary Outcome Measures :
  1. 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%.


  2. 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.



Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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).
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
  • 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.
Contacts and Locations

Sponsors and Collaborators
Bernardete Pessoa MD
Investigators
Layout table for investigator information
Study Director: João Melo-Beirão, MD, PhD Centro Hospitalar do Porto
Tracking Information
First Submitted Date July 10, 2019
First Posted Date July 15, 2019
Last Update Posted Date July 23, 2019
Actual Study Start Date January 1, 2012
Actual Primary Completion Date June 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 21, 2019)
  • 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.
Original Primary Outcome Measures
 (submitted: July 10, 2019)
  • Anatomical improvement [ 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. ]
    Measured by OCT
  • Functional improvement [ 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. ]
    Measured by ETDRS assessment
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema
Official Title Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema
Brief 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).

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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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).
Condition
  • Diabetic Macular Edema
  • Diabetic Retinopathy
Intervention
  • Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]
  • Drug: Aflibercept 40 MG/ML Intraocular Solution [EYLEA]
Study Groups/Cohorts
  • ranibizumab
    Patients nonresponsive to bevacizumab that were switched to ranibizumab
    Intervention: Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]
  • aflibercept
    Patients nonresponsive to bevacizumab that were switched to aflibercept
    Intervention: Drug: Aflibercept 40 MG/ML Intraocular Solution [EYLEA]
Publications * Pessoa B, Malheiro L, Carneiro I, Monteiro S, Coelho J, Coelho C, Figueira J, Meireles A, Melo Beirão 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 10, 2019) 		40
Original Actual Enrollment Same as current
Actual Study Completion Date June 30, 2016
Actual Primary Completion Date June 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
  • 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04018833
Other Study ID Numbers 20190701245703984
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Bernardete Pessoa MD, Centro Hospitalar do Porto
Study Sponsor Bernardete Pessoa MD
Collaborators Not Provided
Investigators
Study Director: João Melo-Beirão, MD, PhD Centro Hospitalar do Porto
PRS Account Centro Hospitalar do Porto
Verification Date July 2019

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