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The Endurance 1 Trial

NCT02297204 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2019-02-04

No results posted yet for this study

Summary

The Endurance Trial is a phase IV open label clinical study to assess the need for ongoing intravitreal aflibercept injections after the 3-year VISTA DME (VGFT-OD-1009) end-point. Subjects will be treated with intravitreal aflibercept injections pro re nata (PRN) based on the presence of CR-DME (Clinically Relevant-Diabetic Macular Edema). In addition, subjects who meet re-treatment criteria will be eligible for focal laser treatment every 90 days.

Conditions

Interventions

PROCEDURE

Focal Laser Treatment

All subjects receiving PRN IVT aflibercept injections will be evaluated for focal laser treatment beginning at week 12 through the end of the study. If the subject meets any of the criteria for focal laser treatment (FLT), fluorescein angiography (FA) will be performed to guide the focal laser treatment. Focal laser treatment and focal laser re-treatment will be administered no more than once every 90 days.

DRUG

aflibercept 2.0 mg

If a subject has recurrent CR-DME they will receive an IVT aflibercept injection

Sponsors & Collaborators

Principal Investigators

  • Rahul Khurana, MD · Northern California Retina Vitreous Associates

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2017-12-13
Completion
2018-03-19

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02297204 on ClinicalTrials.gov