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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02559180
Recruitment Status : Recruiting
First Posted : September 24, 2015
Last Update Posted : January 26, 2018
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Rishi Singh, The Cleveland Clinic

Brief Summary:
Treatment of diabetic macular edema with intravitreal aflibercept in subjects previously treated with intravitreal anti-Vegf agents (ranibizumab or bevacizumab)

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Macular Edema Drug: aflibercept Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigator Initiated Observational Study of Intravitreal Aflibercept Injection in Subjects With Diabetic Macular Edema Previously Treated With Ranibizumab or Bevacizumab
Study Start Date : October 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
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

Primary Outcome Measures :
  1. 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.

  2. 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).

Secondary Outcome Measures :
  1. 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.

Other Outcome Measures:
  1. OCT perfusion [ Time Frame: 6 months,12 months, 24 months ]
    Change in macular OCT perfusion at months 6,12 and 24 by OCT angiography

  2. 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

  3. 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

  4. 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

  5. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02559180

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Contact: Rishi P Singh, MD 216-445-9497
Contact: Angela Borer, BS 216-445-7176

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United States, Ohio
Cole Eye Institute, Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Rishi Singh, M.D.    216-445-9497   
Contact: Diana C McOwen, RN, BSN    216-445-3762   
Principal Investigator: Rishi Singh, M.D.         
Sponsors and Collaborators
Rishi Singh
Regeneron Pharmaceuticals
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Principal Investigator: Rishi P Singh, MD The Cleveland Clinic

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Responsible Party: Rishi Singh, staff surgeon/Sponsor-Investigator, The Cleveland Clinic Identifier: NCT02559180     History of Changes
Other Study ID Numbers: SwapTwo Study
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Rishi Singh, The Cleveland Clinic:
Macular Edema
Diabetic Retinopathy

Additional relevant MeSH terms:
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Macular Edema
Retinal Diseases
Diabetic Retinopathy
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors