NCT01870427

Brief Summary

The purpose of the study is to determine the effect of Intravitreal Aflibercept Injection (IAI) on previously treated Central Retinal Vein Occlusions (CRVOs) with other Anti-VEGF agents.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2013

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

December 8, 2016

Status Verified

December 1, 2016

Enrollment Period

2.2 years

First QC Date

May 25, 2013

Last Update Submit

December 7, 2016

Conditions

Macular Edema With Central Retinal Vein Occlusions

Keywords

Macular EdemaCentral Retinal Vein OcclusionCRVOAfliberceptVEGF Trap-EyeEyleaRanibizumabBevacizumab

Outcome Measures

Primary Outcomes (1)

  • Duration of Intravitreal Aflibercept on Treatment Interval

    Mean number of weeks between each injection where there is no macular edema

    52 Weeks

Secondary Outcomes (4)

  • Change in Visual Acuity

    52 Weeks

  • Retinal Thickness

    52 Weeks

  • Adverse Events

    52 Weeks

  • Number of Treatments

    52 Weeks

Study Arms (1)

Aflibercept (2.0 mg)

EXPERIMENTAL

Intravitreal Aflibercept (2.0 mg)

Drug: Aflibercept (2.0 mg)

Interventions

Aflibercept (2.0 mg)DRUG

Intravitreal Aflibercept (2.0 mg)

Also known as: Eylea, VEGF Trap-EYE
Aflibercept (2.0 mg)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 and above with documented history of center-involved macular edema secondary to CRVO.
  • Patients must have received treatment for at least 6 months before baseline, with 3 initial loading doses, and evidence of recurrence of edema when extended beyond 4 weeks.
  • Protocol refracted ETDRS BCVA of 20/25 to 20/320 (73-24 letters).
  • Willing and able to comply with clinic visits and study-related procedures.
  • Provide signed informed consent.

You may not qualify if:

  • Prior panretinal or macular laser photocoagulation
  • Previous use of intraocular corticosteroids or use of periocular corticosteroids within the 3 months prior to day 1
  • Prior treatment with systemic anti-VEGF agents
  • Presence of iris neovascularization
  • Vitreous hemorrhage in the Study Eye
  • Traction retinal detachment, or preretinal fibrosis involving the macula
  • Diabetic macular edema or diabetic retinopathy, defined as eyes of diabetic patients with more than 1 microaneurysm outside the area of the vein occlusion.
  • Infectious blepharitis, keratitis, scleritis, or conjunctivitis.
  • Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye.
  • Uncontrolled glaucoma in the study eye (defined as intraocular pressure equal or greater than 30mmHg despite treatment with anti-glaucoma medication)
  • Concurrent eye disease in the study eye that could compromise visual acuity (e.g. advanced glaucoma, age-related macular degeneration, etc)
  • Any concurrent intraocular condition in the study eye (e.g. glaucoma) that, in the opinion of the investigator, could either require medical or surgical intervention during the 52 weeks study period to prevent or treat visual loss that might result from that condition.
  • 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 \[IUD\]; bilateral tubal ligation; vasectomy; condom plus, contraceptive sponge, foam or jelly, or diaphragm) \*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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern California Retina Vitreous Associates

Mountain View, California, 94040, United States

Location

Related Publications (5)

  • Brown DM, Heier JS, Clark WL, Boyer DS, Vitti R, Berliner AJ, Zeitz O, Sandbrink R, Zhu X, Haller JA. Intravitreal aflibercept injection for macular edema secondary to central retinal vein occlusion: 1-year results from the phase 3 COPERNICUS study. Am J Ophthalmol. 2013 Mar;155(3):429-437.e7. doi: 10.1016/j.ajo.2012.09.026. Epub 2012 Dec 4.

    PMID: 23218699BACKGROUND

  • Boyer D, Heier J, Brown DM, Clark WL, Vitti R, Berliner AJ, Groetzbach G, Zeitz O, Sandbrink R, Zhu X, Beckmann K, Haller JA. Vascular endothelial growth factor Trap-Eye for macular edema secondary to central retinal vein occlusion: six-month results of the phase 3 COPERNICUS study. Ophthalmology. 2012 May;119(5):1024-32. doi: 10.1016/j.ophtha.2012.01.042. Epub 2012 Mar 21.

    PMID: 22440275BACKGROUND

  • Heier JS, Campochiaro PA, Yau L, Li Z, Saroj N, Rubio RG, Lai P. Ranibizumab for macular edema due to retinal vein occlusions: long-term follow-up in the HORIZON trial. Ophthalmology. 2012 Apr;119(4):802-9. doi: 10.1016/j.ophtha.2011.12.005. Epub 2012 Feb 1.

    PMID: 22301066BACKGROUND

  • Campochiaro PA, Brown DM, Awh CC, Lee SY, Gray S, Saroj N, Murahashi WY, Rubio RG. Sustained benefits from ranibizumab for macular edema following central retinal vein occlusion: twelve-month outcomes of a phase III study. Ophthalmology. 2011 Oct;118(10):2041-9. doi: 10.1016/j.ophtha.2011.02.038. Epub 2011 Jun 29.

    PMID: 21715011BACKGROUND

  • Khurana RN, Chang LK, Bansal AS, Palmer JD, Wu C, Wieland MR. Treat and extend regimen with aflibercept for chronic central retinal vein occlusions: 2 year results of the NEWTON study. Int J Retina Vitreous. 2019 Apr 15;5:10. doi: 10.1186/s40942-019-0159-x. eCollection 2019.

    PMID: 31016030DERIVED

MeSH Terms

Conditions

Macular EdemaRetinal Vein Occlusion

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Rahul N Khurana, MD

    Northern California Retina Vitreous Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 25, 2013

First Posted

June 6, 2013

Study Start

June 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2016

Last Updated

December 8, 2016

Record last verified: 2016-12

Locations

US(1)