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

Primary Purpose

Retinal Vein Occlusion

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aflibercept
Sponsored by
Tennessee Retina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Vein Occlusion focused on measuring Retinal Vein Occlusion, Central Retinal Vein Occlusion, Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tennessee Retina, PC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aflibercept 2.0mg

Arm Description

Single arm - Intravitreal Aflibercept 2.0mg, 0.05 milliliters, monthly for 6 months.

Outcomes

Primary Outcome Measures

Complete anatomic resolution of macular edema following central retinal vein occlusion (CRVO) as measured by Optical Coherence Tomography (OCT)

Secondary Outcome Measures

Extent of reduction in macular thickness
Extent of reduction in macular volume
Mean change in best-corrected visual acuity (BCVA)
Proportion of patients with gain or loss of 5, 10, and 15 letters in BCVA
Number and severity of adverse events

Full Information

First Posted
May 16, 2013
Last Updated
October 27, 2014
Sponsor
Tennessee Retina
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01857544
Brief Title
Study of Intravitreal Aflibercept Injection for Persistent CRVO-associated Macular Edema Despite Prior Anti-VEGF Therapy
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 Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tennessee Retina
Collaborators
Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Vein Occlusion
Keywords
Retinal Vein Occlusion, Central Retinal Vein Occlusion, Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aflibercept 2.0mg
Arm Type
Experimental
Arm Description
Single arm - Intravitreal Aflibercept 2.0mg, 0.05 milliliters, monthly for 6 months.
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Other Intervention Name(s)
VEGF-Trap, Eylea
Intervention Description
Monthly 2.0mg Aflibercept Intravitreal Injection
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Extent of reduction in macular thickness
Time Frame
Month 6
Title
Extent of reduction in macular volume
Time Frame
Month 6
Title
Mean change in best-corrected visual acuity (BCVA)
Time Frame
Month 6
Title
Proportion of patients with gain or loss of 5, 10, and 15 letters in BCVA
Time Frame
Month 6
Title
Number and severity of adverse events
Time Frame
6 month-period
Other Pre-specified Outcome Measures:
Title
Effect on macular leakage using fluorescein angiogram (FA)
Time Frame
Month 6
Title
Effect on peripheral retinal non-perfusion
Time Frame
Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franco M Recchia, MD
Organizational Affiliation
Tennessee Retina, PC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tennessee Retina, PC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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