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Treatment of Diabetic Macular Edema With Aflibercept in Subjects Previously Treated With Ranibizumab or Bevacizumab (SwapTwo)

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ClinicalTrials.gov Identifier: NCT02559180
Recruitment Status : Recruiting
First Posted : September 24, 2015
Last Update Posted : January 26, 2018
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Rishi Singh, The Cleveland Clinic

Tracking Information
First Submitted Date  ICMJE September 22, 2015
First Posted Date  ICMJE September 24, 2015
Last Update Posted Date January 26, 2018
Study Start Date  ICMJE October 2015
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2015)
  • Safety and Efficacy [ Time Frame: 30 days ]
    Subjects will be evaluated monthly for safety, efficacy as measured by SDOCT and best corrected visual acuity (BCVA) using the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) protocol.
  • Central Foveal Thickness [ Time Frame: 12 months ]
    The primary study endpoint is the mean absolute change from baseline central foveal thickness at month 12 as measured by SDOCT (defined as the average thickness within the central 1mm subfield).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02559180 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2016)
Visual Acuity-mean change [ Time Frame: 6 months, 12 months, 24 months ]
The mean change from baseline in best-corrected visual acuity (BCVA) score at months 6,12 and 24.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2015)
Visual Acuity-mean change [ Time Frame: 6 months and 12 months ]
The mean change from baseline in best-corrected visual acuity (BCVA) score at months 6 and 12.
Current Other Pre-specified Outcome Measures
 (submitted: September 29, 2016)
  • OCT perfusion [ Time Frame: 6 months,12 months, 24 months ]
    Change in macular OCT perfusion at months 6,12 and 24 by OCT angiography
  • Diabetic retinopathy severity [ Time Frame: 6 months and 12 months ]
    The diabetic retinopathy severity change from baseline at month 6 and 12 as measured by the simplified ETDRS scale
  • Retinal vascular changes by OCT angiography [ Time Frame: 6 months,12 months, 24 months ]
    Presence of microaneurysm and capillary dropout on OCT angiography at month 6, month 12 and month 24 by OCT angiography
  • Absence of retinal fluid as measured by OCT [ Time Frame: 6 months,12 months, 24 months ]
    The percentage of subjects that were anatomically 'dry' by SDOCT at months 6,12 and 24
  • Visual Acuity-gain or loss of letters [ Time Frame: 6 months, 12 months, 24 months ]
    The percentage of participants who gained or lost 5, 10, and 15 letters or more of vision at months 6,12 and 24. The percentage of patients that are 20/40 or better at months 6,12 and 24. The percentage of patients that are 20/200 or worse at months 6,12 and 24.
Original Other Pre-specified Outcome Measures
 (submitted: September 22, 2015)
  • OCT perfusion [ Time Frame: 6 months and 12 months ]
    Change in macular OCT perfusion at month 6 and 12 by OCT angiography
  • Diabetic retinopathy severity [ Time Frame: 6 months and 12 months ]
    The diabetic retinopathy severity change from baseline at month 6 and 12 as measured by the simplified ETDRS scale
  • Retinal vascular changes by OCT angiography [ Time Frame: 6 months and 12 months ]
    Presence of microaneurysm and capillary dropout on OCT angiography at month 6 and month 12 by OCT angiography
  • Absence of retinal fluid as measured by OCT [ Time Frame: 6 months and 12 months ]
    The percentage of subjects that were anatomically 'dry' by SDOCT at months 6 and 12
  • Visual Acuity-gain or loss of letters [ Time Frame: 6 months and 12 months ]
    The percentage of participants who gained or lost 5, 10, and 15 letters or more of vision at months 6 and 12 The percentage of patients that are 20/40 or better at months 6 and 12 The percentage of patients that are 20/200 or worse at months 6 and 12
 
Descriptive Information
Brief Title  ICMJE Treatment of Diabetic Macular Edema With Aflibercept in Subjects Previously Treated With Ranibizumab or Bevacizumab
Official Title  ICMJE Investigator Initiated Observational Study of Intravitreal Aflibercept Injection in Subjects With Diabetic Macular Edema Previously Treated With Ranibizumab or Bevacizumab
Brief Summary Treatment of diabetic macular edema with intravitreal aflibercept in subjects previously treated with intravitreal anti-Vegf agents (ranibizumab or bevacizumab)
Detailed Description

This study is an investigator initiated interventional study for subjects with diabetic macular edema that have been previously treated with bevacizumab or ranibizumab. Intravitreal aflibercept 2mg will be given until OCT (ocular coherence tomography) demonstrates an absence of fluid. Continued intravitreal aflibercept 2mg will then take place every 2 months for a total of 24 months of treatment.

This study is an interventional, single arm, investigator initiated study. Subjects will be given 2 mg (0.05 mL or 50 microliters) of IAI injection administered monthly until OCT demonstrates no evidence of fluid as defined by the protocol, followed by 2 mg (0.05 mL) once every 2 months. Each subject will be evaluated for 24 months. Thus, the study duration will be 24 months plus the recruitment period.

Subjects will be evaluated for safety, efficacy as measured by SDOCT and best corrected visual acuity (BCVA) using the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) protocol. In additional, fundus photography, fluorescein angiography, and OCT angiography will be performed at baseline, month 6, month 12 and at the final visit.

Only one eye per subject may be enrolled in the study. If a subject's fellow (non-study) eye requires treatment for at study entry, or during the subject's participation in the study, the fellow eye can receive IAI injection for DME.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetic Retinopathy
  • Macular Edema
Intervention  ICMJE Drug: aflibercept
aflibercept 2mg given intravitreally every month until resolution of fluid in retina and then continued every 2 months for a total of 24 months of treatment
Other Name: Eylea
Study Arms  ICMJE Experimental: Single Arm
aflibercept 2mg given intravitreally every month until resolution of fluid in retina and then continued every 2 months for a total of 24 months of treatment
Intervention: Drug: aflibercept
Publications *

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 22, 2015)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Men and women ≥ 18 years of age.
  2. Foveal-involving retinal edema secondary to DME based on investigator review of clinical exam and SDOCT with central subfield thickness value of 325 microns by Zeiss Cirrus SD-OCT.
  3. E-ETDRS best-corrected visual acuity of: 20/25 to 20/400 in the study eye.
  4. History of previous treatment with anti-VEGF with at least 4 injections over the last 6 months.
  5. Willing, committed, and able to return for ALL clinic visits and complete all study related procedures.
  6. Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member.) understand and willing to sign the informed consent form.

    -

Exclusion Criteria:

  1. Any prior or concomitant therapy with another investigational agent to treat DME in the study eye.
  2. Prior panretinal photocoagulation in the study eye within the past 3 months.
  3. Prior intravitreal anti-VEGF therapy in the study eye within 30 days of enrollment.
  4. Prior systemic anti-VEGF therapy, investigational or FDA-approved, is only allowed up to 3 months prior to first dose, and will not be allowed during the study.
  5. Previous treatment with intravitreal aflibercept injection
  6. Significant vitreous hemorrhage obscuring view to the macula or the retinal periphery as determined by the investigator on clinical exam
  7. Presence of other causes of macular edema, including pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25 mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, choroidal neovascularization, age-related macular degeneration or multifocal choroiditis in the study eye.
  8. Presence of macula-threatening traction retinal detachment.
  9. Prior vitrectomy in the study eye.
  10. History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
  11. Any history of macular hole of stage 2 and above in the study eye.
  12. Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of day 1, as long as it's unlikely to interfere with the injection.
  13. Uncontrolled glaucoma at baseline evaluation
  14. Active intraocular inflammation in either eye.
  15. Active ocular or periocular infection in either eye.
  16. Any ocular or periocular infection within the last 2 weeks prior to Screening in either eye.
  17. Any history of uveitis in either eye.
  18. History of corneal transplant or corneal dystrophy in the study eye.
  19. Significant media opacities, including cataract, in the study eye which might interfere with visual acuity, assessment of safety, or fundus photography.
  20. Any concurrent intraocular condition in the study eye (e.g. cataract) that, in the opinion of the investigator, could require either medical or surgical intervention during the 52 week study period.
  21. Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the subject beyond what is to be expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety.
  22. Participation as a subject in any clinical study within the 12 weeks prior to Day 1.
  23. Any systemic therapy with an investigational agent in the past 3 months prior to Day 1.
  24. Any history of allergy to povidone iodine.
  25. Pregnant or breast-feeding women
  26. Women of childbearing potential who are unwilling to practice adequate contraception during the study -
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: Rishi P Singh, MD 216-445-9497 singhr@ccf.org
Contact: Angela Borer, BS 216-445-7176 borera@ccf.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02559180
Other Study ID Numbers  ICMJE SwapTwo Study
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Rishi Singh, The Cleveland Clinic
Study Sponsor  ICMJE Rishi Singh
Collaborators  ICMJE Regeneron Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Rishi P Singh, MD The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date January 2018

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