Skip to main content
OpenTrials
Completed

NCT Number: NCT02734407

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Clinically Significant Diabetic Macular Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assigned Intervention

Procedure

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

aflibercept 2.0 mg

Drug

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

Other names: Eylea, VEGF-Trap

Primary outcomes

  1. Mean number of intravitreal aflibercept injections in 52 weeks

    Time frame: 12 months

  2. Proportion of subjects receiving 0 aflibercept injections in 52 weeks

    Time frame: 12 months

  3. Longer-term efficacy of aflibercept intravitreal injections as assessed by the mean number of injections in 52 weeks

    Time frame: 12 months

  4. Safety of ongoing aflibercept intravitreal injections as assessed by the incidence and severity of ocular and systemic adverse events

    Time frame: 12 months

Secondary outcomes

  1. Vision Change

    Time frame: 12 months

    Mean change in visual acuity from baseline to week 52

  2. Vision loss

    Time frame: 12 months

    Proportion of subjects with gain or loss of 0 to 5 letters from baseline to week 52

  3. Change in central retinal thickness

    Time frame: 12 months

    Mean change in central retinal thickness from baseline to week 52

  4. 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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Retina-Vitreous Associates Medical Group

Other

Registry information

Official study title

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

Acronym: Endurance3

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 12, 2016
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.