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Study of Intravitreal Aflibercept Injection for Persistent CRVO-associated Macular Edema Despite Prior Anti-VEGF Therapy

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. Read our disclaimer for details. Identifier: NCT01857544
Recruitment Status : Unknown
Verified October 2014 by Tennessee Retina.
Recruitment status was:  Active, not recruiting
First Posted : May 20, 2013
Last Update Posted : October 29, 2014
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Tennessee Retina

Brief Summary:
The purpose of this study is determine the number of patients with complete resolution of macular edema secondary to central retinal vein occlusion following 6 monthly injections of Aflibercept.

Condition or disease Intervention/treatment Phase
Retinal Vein Occlusion Drug: Aflibercept Phase 4

Detailed Description:
Twenty (20) consented participant who meet the inclusion criteria will be enrolled to be followed for 6 months. All subjects will receive monthly 2.0 mg intravitreal aflibercept injections.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Intravitreal Aflibercept Injection for Recalcitrant Central Retinal Vein Occlusion Associated Macular Edema Despite Prior Anti-Vascular Endothelial Growth Factor (VEGF) Therapy. (ARChiMEDES)
Study Start Date : June 2013
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: Aflibercept 2.0mg
Single arm - Intravitreal Aflibercept 2.0mg, 0.05 milliliters, monthly for 6 months.
Drug: Aflibercept
Monthly 2.0mg Aflibercept Intravitreal Injection
Other Names:
  • VEGF-Trap
  • Eylea

Primary Outcome Measures :
  1. Complete anatomic resolution of macular edema following central retinal vein occlusion (CRVO) as measured by Optical Coherence Tomography (OCT) [ Time Frame: From baseline to Month 6 ]

Secondary Outcome Measures :
  1. Extent of reduction in macular thickness [ Time Frame: Month 6 ]
  2. Extent of reduction in macular volume [ Time Frame: Month 6 ]
  3. Mean change in best-corrected visual acuity (BCVA) [ Time Frame: Month 6 ]
  4. Proportion of patients with gain or loss of 5, 10, and 15 letters in BCVA [ Time Frame: Month 6 ]
  5. Number and severity of adverse events [ Time Frame: 6 month-period ]

Other Outcome Measures:
  1. Effect on macular leakage using fluorescein angiogram (FA) [ Time Frame: Month 6 ]
  2. Effect on peripheral retinal non-perfusion [ Time Frame: Month 6 ]

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:A patient must meet the following criteria to be eligible for inclusion in the study:

  • Age >18 years
  • Documented macular edema following central retinal vein occlusion
  • Currently receiving treatment with intravitreal anti-VEGF therapy initiated at least 3 months months previously
  • Documented intravitreal treatment with ranibizumab 0.5 mg (at least 3 doses, each one month apart) or bevacizumab 1.25 mg (at least 3 doses, each one month apart)
  • Presence of persistent macular edema (defined as any of the following):

    • central foveal thickness (CFT) of > 300 microns by spectral-domain OCT
    • presence of any intraretinal or subretinal fluid
    • Receipt of intravitreal anti-VEGF injections more frequently than once per month
  • Willingness and ability to comply with clinic visits and study-related procedures
  • Ability to provide signed informed consent

Exclusion Criteria:

  • Prior vitrectomy in the study eye
  • Concurrent retinal vascular disease in the study eye that could compromise visual acuity or contribute to macular edema (e.g. diabetic retinopathy, age-related macular degeneration)
  • Any concurrent intraocular condition in the study eye (e.g. diabetic retinopathy, advanced glaucoma) that, in the opinion of the investigator, could either

    • require medical or surgical intervention during the 6-month study period to prevent or treat visual loss; or,
    • if allowed to progress untreated, contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the 6 month study period
  • Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye
  • Current vitreous hemorrhage in the study eye
  • Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
  • Intraocular surgery (including cataract surgery) in the study eye within 60 days preceding baseline
  • Systemic anti-VEGF treatment within the last 3 months prior to screening
  • Prior intravitreal aflibercept injection in the study eye
  • Macular laser photocoagulation within 4 months of screening
  • Intravitreal or periocular corticosteroid within 4 months of screening
  • Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with ocular antihypertensive medication)
  • Allergy to fluorescein, povidone iodine (Betadine) or aflibercept
  • Participation in a study of an investigational drug or device within 30 days prior to potential enrollment into the study
  • Patients with cognitive dysfunction such as dementia, Alzheimer's disease or any other neuro-degenerative disorder.
  • Pregnant or breast-feeding women
  • Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)

    • Contraception is not required for men with documented vasectomy. **Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.

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): NCT01857544

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United States, Tennessee
Tennessee Retina, PC
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Tennessee Retina
Regeneron Pharmaceuticals
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Principal Investigator: Franco M Recchia, MD Tennessee Retina, PC
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Responsible Party: Tennessee Retina Identifier: NCT01857544    
Other Study ID Numbers: VGFT-OD-1313
VGFT-OD-1313 ( Other Identifier: Regeneron Pharmaceuticals )
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: October 29, 2014
Last Verified: October 2014
Keywords provided by Tennessee Retina:
Retinal Vein Occlusion
Central Retinal Vein Occlusion
Macular Edema
Additional relevant MeSH terms:
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Macular Edema
Retinal Vein Occlusion
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases