Study to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe

NCT03767738 | Completed Phase 4 Results FDA Drug

• 1 other identifier: VGFTe-OD-1881
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chorioretinal Vascular Disease

Outcome Measures

Primary Outcomes (1)

• Number of Aflibercept Injections Successfully Administered Utilizing the Prefilled Syringe (PFS)

  Participants received a single dose of study drug, administered in the selected study eye with the PFS by a retina specialist. Physician assessed successful aflibercept preparation and administration with the PFS.

  At Day 1

Secondary Outcomes (2)

• Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29

  Baseline through Day 29

• Incidence of Ocular Serious TEAEs of Study Eye Through Day 29

  Baseline through Day 29

Study Arms (1)

Intravitreal Aflibercept Injection (IAI)

EXPERIMENTAL

Cohort 1 - Initial patients Cohort 2 - Additional patients

Drug: Intravitreal Aflibercept Injection (IAI)

Interventions

Intravitreal Aflibercept Injection (IAI) DRUG

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

Also known as: Aflibercept, EYLEA®

Intravitreal Aflibercept Injection (IAI)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (2)

Regeneron Study Site

Houston, Texas, 77030, United States

Location

Regeneron Study Site

The Woodlands, Texas, 77384, United States

Location

MeSH Terms

Interventions

aflibercept

Results Point of Contact

• Title: Clinical Trial Management
• Organization: Regeneron Pharmaceuticals, Inc

clinicaltrials@regeneron.com

844-734-6643

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 7, 2018
• Study Start: December 19, 2018
• Primary Completion: August 19, 2020
• Study Completion: August 19, 2020
• Last Updated: September 16, 2021
• Results First Posted: September 16, 2021

Record last verified: 2021-08

Locations

US (2)