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

NCT01857544 | Unknown Phase 4

• 1 other identifier: VGFT-OD-1313
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Vein Occlusion

Keywords

Retinal Vein Occlusion; Central Retinal Vein Occlusion; Macular Edema

Outcome Measures

Primary Outcomes (1)

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

  From baseline to Month 6

Secondary Outcomes (5)

• Extent of reduction in macular thickness

  Month 6

• Extent of reduction in macular volume

  Month 6

• Mean change in best-corrected visual acuity (BCVA)

  Month 6

• Proportion of patients with gain or loss of 5, 10, and 15 letters in BCVA

  Month 6

• Number and severity of adverse events

  6 month-period

Other Outcomes (2)

• Effect on macular leakage using fluorescein angiogram (FA)

  Month 6

• Effect on peripheral retinal non-perfusion

  Month 6

Study Arms (1)

Aflibercept 2.0mg

EXPERIMENTAL

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

Drug: Aflibercept

Interventions

Aflibercept DRUG

Monthly 2.0mg Aflibercept Intravitreal Injection

Also known as: VEGF-Trap, Eylea

Aflibercept 2.0mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tennessee Retina: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Tennessee Retina, PC

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Retinal Vein Occlusion; Macular Edema

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Macular Degeneration; Retinal Degeneration

Study Officials

• Franco M Recchia, MD

  Tennessee Retina, PC

  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: SPONSOR

Study Record Dates

• First Submitted: May 16, 2013
• First Posted: May 20, 2013
• Study Start: June 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: October 29, 2014

Record last verified: 2014-10

Locations

US (1)