Intravitreal Aflibercept for Submacular Hemorrhage

NCT03169660 | Completed Phase 4

• 1 other identifier: A-2014-032
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The prognosis of exudative age-related macular degeneration (AMD) accompanied by submacular hemorrhage is generally poor. A recently developed anti-VEGF agent eyeliaTM is also a useful treatment option for exudative AMD. However, one major limitation of VIEW study was that lack of data regarding eyes with submacular hemorrhage. The purpose of the present study was to evaluate the efficacy of Eylea in submacular hemorrhage secondary to exudative AMD.

Conditions

Exudative Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Changes in Early Treatment of Diabetic Retinopathy Study visual acuity Score

  Increase or decrease in the Early Treatment of Diabetic Retinopathy Study letter score

  Changes from baseline in visual acuity at 56 weeks

Secondary Outcomes (5)

• Proportion of patients who exhibited 15 letters or greater change in visual acuity

  56 weeks

• Changes in central macular thickness

  Changes from baseline in central macular thickness at 56 weeks

• Duration of complete hemorrahge resolution

  56 weeks

• Incidence of recurrence of submacular hemorrhage or fluid

  56 weeks

• Leakage on angiography

  56 week

Study Arms (1)

Treatment group

EXPERIMENTAL

Eyes with submacular hemorrhage secondary to exudative age-related macular degeneration and were treated with vascular endothelial growth factor trap-eye.

Drug: Vascular endothelial growth factor trap-eye

Interventions

Vascular endothelial growth factor trap-eye DRUG

Intravitreal injection of vascular endothelial growth factor trap-eye During the first 3 months, 3 monthly injections are performed After 3 serial injections, additional injections are performed once per 2 months until 48 weeks after the initial injection.

Also known as: Eylea

Treatment group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of older
• Newly diagnosed, treatment-naïve exudative AMD
• Fovea-involving submacular hemorrhage greater than 1 disc areas at diagnosis

You may not qualify if:

• History of previous treatment for neovascular AMD
• Greater than 15 disc diameter areas of hemorrhage extent
• History of vitreoretinal surgery
• History of glaucoma surgery, such as trabeculectomy or glaucoma implant surgery
• History of ocular steroid injection therapy within 1 month
• History of cataract surgery within 3 months
• Aphakia or anterior chamber intraocular lens implantation
• Spherical equivalents greater than -6.0 diopters
• evidence of other retinal disorders that may affect visual function including diabetic retinopathy, hypertensive retinopathy, epiretinal membrane, macular hole, and microaneurysm
• severe media opacity
• uncontrolled systemic disorders, including hypertension or diabetes mellitus
• history of major systemic vascular events, such as myocardial infarction and stroke
• hypersensitivity to aflibercept
• ocular or periocular infection
• active intraocular inflammation

Sponsors & Collaborators

• Kim's Eye Hospital: lead
• Bayer: collaborator

Study Sites (1)

Kim's Eye Hospital

Seoul, 150-034, South Korea

Location

MeSH Terms

Interventions

aflibercept

Study Officials

• Jong Woo Kim, M.D.

  Kim's Eye Hospital, Seoul, South Korea

  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: M.D.

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: May 30, 2017
• Study Start: December 1, 2015
• Primary Completion: January 20, 2019
• Study Completion: January 20, 2019
• Last Updated: February 21, 2019

Record last verified: 2019-02

Locations

KR (1)