Study to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-19

Study Completion Date

2020-08-19

Brief Summary

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The primary objective of the study is to determine if the pre-filled syringe (PFS) supports successful preparation and accurate administration of an aflibercept injection.

The secondary objective of the study is to assess ocular safety in the study eye.

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Detailed Description

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Conditions

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Chorioretinal Vascular Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intravitreal Aflibercept Injection (IAI)

Cohort 1 - Initial patients Cohort 2 - Additional patients

Group Type EXPERIMENTAL

Intravitreal Aflibercept Injection (IAI)

Intervention Type DRUG

IAI prepared and administered with a pre-filled syringe (PFS)

Interventions

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Intravitreal Aflibercept Injection (IAI)

IAI prepared and administered with a pre-filled syringe (PFS)

Intervention Type DRUG

Other Intervention Names

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Aflibercept EYLEA®

Eligibility Criteria

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Inclusion Criteria

* Participants who have neovascular age-related macular degeneration (AMD), diabetic macular edema (DME), retinal vein occlusion (RVO), or diabetic retinopathy (DR) with diabetic macular edema (DME) in the study eye

Exclusion Criteria

* Evidence of active infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
* Any active intraocular inflammation or infection in either eye or history of intraocular inflammation or infection after past intravitreal injection treatment (IVT) injections with any agent in either eye
* History of or any current indication of excessive bleeding and recurrent hemorrhages, including any prior excessive intraocular (including subconjunctival) bleeding or hemorrhages after IVT injection or intraocular procedures in either eye
* Any intraocular surgery in the study eye at any time during the past 3 months
* Current systemic infectious disease or a therapy for active infectious disease
* Pregnant or breastfeeding women

Note: Other inclusion/ exclusion apply

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No