Long-Term Efficacy and Safety of Aflibercept Intravitreal Injections for the Treatment of Diabetic Macular Edema (Endurance3)

March 25, 2019 updated by: Retina-Vitreous Associates Medical Group

Long-Term Efficacy and Safety of Aflibercept Intravitreal Injections for the Treatment of Diabetic Macular Edema in Subjects Who Completed the Three Year VISTA-DME Trial

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) endpoint. Subjects will be treated with intravitreal aflibercept injections pro re nata (PRN) based on the presence of CR-DME (Clinically Relevant-DME). In addition, subjects who meet re-treatment criteria will be eligible for focal laser treatment every 90 days

Study Overview

Detailed Description

The Endurance3 Trial is a Phase IV open label study to assess the need for ongoing intravitreal aflibercept injections after the 3 year VISTA DME (VGFT-OD-1009) endpoint. Subjects will be treated with intravitreal aflibercept injections pro re nata (PRN) upon the presence of CR-DME (Clinically Relevant DME) as noted by OCT (Optical Coherence Tomography) imaging and examination. In addition, subjects who meet the re-treatment criteria will be eligible for focal laser treatment every 90 days.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Enrolled and completed VISTA DME (VGFT-OD-1009) clinical trial
  • Willing and able to comply with clinic visits and study-related procedures
  • Provide signed informed consent
  • Enrollment in the trial within 12 weeks of trial activation

Exclusion Criteria:

  • Prior treatment with anti-VEGF therapy in the study eye within 28 days of baseline
  • Pregnant or breast-feeding women
  • Sexually active ment or women of childbearing potential who are unwilling to practice adequate contraception during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Open-Label Arm

2mg Aflibercept, as needed, intravitreal administration.

All subjects will be treated with intravitreal (IVT) aflibercept injections as needed in the presence of clinically relevant diabetic macular edema (CR-DME). If CR-DME is not present the subject will not receive an IVT aflibercept injection and will be observed.

If a subject has recurrent CR-DME they will receive an IVT aflibercept 2.0 mg injection and interval between visits will be reduced to 4 weeks.

At week 12 through end of study, all subjects will be evaluated for focal laser treatment.

If a subject has recurrent CR-DME they will receive an IVT aflibercept injection
Other Names:
  • Eylea
  • VEGF-Trap
All subjects receiving PRN IVT aflibercept injections will be evaluated for focal laser treatment beginning at week 12 through the end of the study as assigned intervention. 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.
Other Names:
  • FLT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean number of intravitreal aflibercept injections in 52 weeks
Time Frame: 12 months
12 months
Proportion of subjects receiving 0 aflibercept injections in 52 weeks
Time Frame: 12 months
12 months
Longer-term efficacy of aflibercept intravitreal injections as assessed by the mean number of injections in 52 weeks
Time Frame: 12 months
12 months
Safety of ongoing aflibercept intravitreal injections as assessed by the incidence and severity of ocular and systemic adverse events
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of clinically relevant diabetic macular edema
Time Frame: 12 months
Percentage of subjects with no clinically relevant diabetic macular edema seen on SD-OCT from baseline to week 52
12 months
Vision Change
Time Frame: 12 months
Mean change in visual acuity from baseline to week 52
12 months
Vision loss
Time Frame: 12 months
Proportion of subjects with gain or loss of 0 to 5 letters from baseline to week 52
12 months
Change in central retinal thickness
Time Frame: 12 months
Mean change in central retinal thickness from baseline to week 52
12 months
Evaluation of Diabetic Retinopathy (Proportion of subjects with stable, worsened, or improved diabetic retinopathy as identified by eye examination and imaging)
Time Frame: 12 months
Proportion of subjects with stable, worsened, or improved diabetic retinopathy as identified by eye examination and imaging
12 months
Role of focal laser treatment in management of DME (Proportion of subjects that receive focal laser treatment and mean number of intravitreal aflibercept injections before and after receiving focal laser treatment)
Time Frame: 12 months
Proportion of subjects that receive focal laser treatment and mean number of intravitreal aflibercept injections before and after receiving focal laser treatment
12 months
Ocular and systemic adverse events
Time Frame: 12 months
Incidence and severity of ocular and systemic adverse events as identified by eye examinations, imaging, and subject reporting
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ACTUAL)

September 27, 2017

Study Completion (ACTUAL)

September 27, 2017

Study Registration Dates

First Submitted

December 16, 2014

First Submitted That Met QC Criteria

April 5, 2016

First Posted (ESTIMATE)

April 12, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 25, 2019

Last Verified

March 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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