The Endurance 1 Trial (Endurance)
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)
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 4
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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. |
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.
Inne nazwy:
Jeśli pacjent ma nawracające CR-DME, otrzyma zastrzyk afliberceptu IVT
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Need for ongoing intravitreal aflibercept injections in the management of DME
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Vision change
Ramy czasowe: 12 months
|
Mean change in visual acuity from baseline to week 52.
|
12 months
|
|
Vision loss
Ramy czasowe: 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
Ramy czasowe: 12 months
|
Mean change in central retinal thickness from baseline to week 52.
|
12 months
|
|
Rozwój istotnego klinicznie cukrzycowego obrzęku plamki
Ramy czasowe: 12 miesięcy
|
Odsetek pacjentów bez klinicznie istotnego cukrzycowego obrzęku plamki obserwowanego w SD-OCT od wizyty początkowej do 52. tygodnia
|
12 miesięcy
|
|
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.)
Ramy czasowe: 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.)
Ramy czasowe: 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
Ramy czasowe: 12 months
|
Incidence and severity of ocular and systemic adverse events as identified by eye examinations, imaging, and subject reporting.
|
12 months
|
Współpracownicy i badacze
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- REG-2014-11-006
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