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出境医 / 临床实验 / One Year Results of Switching to Aflibercept for Persistent Diabetic Macular Edema Resistant to Bevacizumab

One Year Results of Switching to Aflibercept for Persistent Diabetic Macular Edema Resistant to Bevacizumab

Study Description
Brief Summary:

Purpose: The aim of this study is to evaluate the functional and anatomical effects of switching from Bevacizumab to Aflibercept in patients with persistent DME resistant to Bevacizumab.

Methods: Patients with DME refractory to Bevacizumab (1.25 mg/ 0.05 mL) were subsequently switched to Aflibercept (2.0 mg/0.05 ml). The included patients received 5 loading doses of intravitreal Aflibercept (2.0 mg/0.05 mL) (Eylea; Bayer, Berlin, Germany) given monthly. After the loading dose, Aflibercept was injected every 2 months. The follow up duration was one year.


Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Aflibercept Injection [Eylea] Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: One Year Results of Switching to Aflibercept for Persistent Diabetic Macular Edema Resistant to Bevacizumab
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : April 1, 2017
Actual Study Completion Date : April 1, 2018
Arms and Interventions
Arm Intervention/treatment
Diabetic macular edema resistant to Bevacizumab
Patients resistant to 6 monthly Bevacizumab injection were switched to Aflibercept.
 Drug: Aflibercept Injection [Eylea]
intravitreal injection of Aflibercept in resistant DME.
Outcome Measures
Primary Outcome Measures :
  1. central macular thickness after one year [ Time Frame: 12 months ]
    Optical Coherence Tomography changes after 12 months.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diabetic patients, older than 18years,
  • center-involving DME, central macular thickness (CMT) >300 μm by spectral domain optical coherence tomography (SD-OCT) 1 month after the last Bevacizumab injection.
  • The best corrected visual acuity must be better than 0.05 decimal visual acuity (1.3 log MAR). Only one eye from each patient was included in the study. If both eyes met the inclusion criteria, the eye with worse visual acuity was included.

Exclusion Criteria:

  • Patients were excluded if they had dense media opacity, pregnancy, previous intravitreal steroid therapy.
  • uncontrolled diabetes mellitus (HbA1c ≥ 10%) and prior intraocular surgery (with the exception of uneventful cataract surgery >6 months prior to conversion).
  • Other exclusion criteria included active proliferative diabetic retinopathy, tractional maculopathy, macular ischemia and other ocular diseases: age-related macular degeneration, central/branch retinal vein occlusion, and glaucoma.
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE June 3, 2019
First Posted Date  ICMJE June 4, 2019
Last Update Posted Date June 4, 2019
Actual Study Start Date  ICMJE April 1, 2016
Actual Primary Completion Date April 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2019) 		central macular thickness after one year [ Time Frame: 12 months ]
Optical Coherence Tomography changes after 12 months.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE One Year Results of Switching to Aflibercept for Persistent Diabetic Macular Edema Resistant to Bevacizumab
Official Title  ICMJE One Year Results of Switching to Aflibercept for Persistent Diabetic Macular Edema Resistant to Bevacizumab
Brief Summary

Purpose: The aim of this study is to evaluate the functional and anatomical effects of switching from Bevacizumab to Aflibercept in patients with persistent DME resistant to Bevacizumab.

Methods: Patients with DME refractory to Bevacizumab (1.25 mg/ 0.05 mL) were subsequently switched to Aflibercept (2.0 mg/0.05 ml). The included patients received 5 loading doses of intravitreal Aflibercept (2.0 mg/0.05 mL) (Eylea; Bayer, Berlin, Germany) given monthly. After the loading dose, Aflibercept was injected every 2 months. The follow up duration was one year.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Macular Edema
Intervention  ICMJE Drug: Aflibercept Injection [Eylea]
intravitreal injection of Aflibercept in resistant DME.
Study Arms  ICMJE Diabetic macular edema resistant to Bevacizumab
Patients resistant to 6 monthly Bevacizumab injection were switched to Aflibercept.
Intervention: Drug: Aflibercept Injection [Eylea]
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2019) 		37
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 1, 2018
Actual Primary Completion Date April 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • diabetic patients, older than 18years,
  • center-involving DME, central macular thickness (CMT) >300 μm by spectral domain optical coherence tomography (SD-OCT) 1 month after the last Bevacizumab injection.
  • The best corrected visual acuity must be better than 0.05 decimal visual acuity (1.3 log MAR). Only one eye from each patient was included in the study. If both eyes met the inclusion criteria, the eye with worse visual acuity was included.

Exclusion Criteria:

  • Patients were excluded if they had dense media opacity, pregnancy, previous intravitreal steroid therapy.
  • uncontrolled diabetes mellitus (HbA1c ≥ 10%) and prior intraocular surgery (with the exception of uneventful cataract surgery >6 months prior to conversion).
  • Other exclusion criteria included active proliferative diabetic retinopathy, tractional maculopathy, macular ischemia and other ocular diseases: age-related macular degeneration, central/branch retinal vein occlusion, and glaucoma.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03974425
Other Study ID Numbers  ICMJE 31184
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: protecting patient privacy
Responsible Party Mahmoud Abouhussein, University of Alexandria
Study Sponsor  ICMJE University of Alexandria
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Alexandria
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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