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The Endurance 1 Trial (Endurance)

1. februar 2019 opdateret af: Rahul Khurana, M.D., Northern California Retina Vitreous Associates

Long-Term Efficacy and Safety of Intravitreal Aflibercept Injections for the Treatment of Diabetic Macular Edema in Subjects Who Completed the Three Year VISTA-DME Trial (The Endurance 1 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) 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The safety and tolerability of intravitreal aflibercept injections have been investigated in previous Phase I, I/II and III studies in AMD, RVO, and DME trials. Potential safety issues associated with the route of administration or the pharmacology of aflibercept in the study population include decreased BCVA, intraocular inflammation, intraocular infection, transient and/or sustained elevation of intraocular pressure (IOP), cataract development or progression, retinal or intravitreal hemorrhage, macular edema, retinal break or detachment, and arterial thromboembolic events (ATEs). Safety will be assessed by visual acuity, ophthalmic examinations, fluorescein angiograms, OCT, intraocular pressure, vital signs, and adverse event documentation.

To minimize the risks of intraocular infections, all injections will be performed employing sterile techniques as described in Appendix A. Study drug administration will be held for subjects who experience certain ocular events or infections. In the event any subject develops an adverse event in the study eye that is considered by the evaluating physician to be severe in intensity, serious consideration should be given to withdrawing the subject from the study.

The PI or designated Sub-Investigators will review all adverse events on an ongoing basis to determine causality and relationship to study drug and/or study procedures.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

9

Fase

  • Fase 4

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  1. Prior treatment with anti-VEGF therapy in the study eye within 28 days of baseline
  2. Pregnant or breast-feeding women

  3. Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly).

    • Contraception is not required for men with documented vasectomy. **Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: aflibercept

2mg, 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.
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.
Andre navne:
  • FLT
Medicin: aflibercept 2,0 mg
Hvis en person har tilbagevendende CR-DME, vil de modtage en IVT aflibercept-injektion
Andre navne:
  • Eylea

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Need for ongoing intravitreal aflibercept injections in the management of DME
Tidsramme: 12 months
To assess the need for ongoing intravitreal aflibercept injections for subjects who were enrolled and completed the 3-year VISTA DME (VGFT-OD-1009) trial and to characterize long-term efficacy and safety of aflibercept intravitreal injections in the management of DME by evaluating mean number of injections in 52 weeks and proportion of subjects receiving 0 (zero) injections in 52 weeks.
12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Vision change
Tidsramme: 12 months
Mean change in visual acuity from baseline to week 52.
12 months
Vision loss
Tidsramme: 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
Tidsramme: 12 months
Mean change in central retinal thickness from baseline to week 52.
12 months
Udvikling af klinisk relevant diabetisk makulaødem
Tidsramme: 12 måneder
Procentdel af forsøgspersoner uden klinisk relevant diabetisk makulaødem set på SD-OCT fra baseline til uge 52
12 måneder
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.)
Tidsramme: 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
Evaluation of Diabetic Retinopathy (Proportion of subjects with stable, worsened, or improved diabetic retinopathy as identified by eye examination and imaging.)
Tidsramme: 12 months
Proportion of subjects with stable, worsened, or improved diabetic retinopathy as identified by eye examination and imaging.
12 months
Ocular and systemic adverse events
Tidsramme: 12 months
Incidence and severity of ocular and systemic adverse events as identified by eye examinations, imaging, and subject reporting.
12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Northern California Retina Vitreous Associates

Samarbejdspartnere

Regeneron Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2014

Primær færdiggørelse (Faktiske)

13. december 2017

Studieafslutning (Faktiske)

19. marts 2018

Datoer for studieregistrering

Først indsendt

14. november 2014

Først indsendt, der opfyldte QC-kriterier

20. november 2014

Først opslået (Skøn)

21. november 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. februar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. februar 2019

Sidst verificeret

1. februar 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • REG-2014-11-006

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Kliniske forsøg med Diabetisk makulært ødem

Kliniske forsøg med Focal Laser Treatment

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Placeringer

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