Phase 4
Completed N=60
Long-Term Efficacy & Safety of Aflibercept IVT for the Treatment of DME in Subjects Who Completed the VISTA-DME Trial
Source: ClinicalTrials.gov NCT02299336 ↗Enrolled (actual)
60
Serious AEs
31.7%
Results posted
Jun 2018
Primary outcomePrimary: Mean Number of Intravitreal Aflibercept Injections for Subjects Who Were Enrolled and Completed the 3-year VISTA DME (VGFT-OD-1009) Trial — 9.5 injections
◆ Published Evidence
Established
40citations · ~5 / year
Long-term outcomes with as-needed aflibercept in diabetic macular oedema: 2-year outcomes of the ENDURANCE extension 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; NCT01363440) end-point. 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.
Linked Publications
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Long-term outcomes with as-needed aflibercept in diabetic macular oedema: 2-year outcomes of the ENDURANCE extension study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Number of Intravitreal Aflibercept Injections for Subjects Who Were Enrolled and Completed the 3-year VISTA DME (VGFT-OD-1009) Trial |
9.5 | — |
| SECONDARY Mean Change in Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity From Baseline to Week 52 and Baseline to Week 104 |
0.61; 0.83 | — |
| SECONDARY Mean Number of Intravitreal Aflibercept Injections Before and After Receiving First Focal Laser Application. |
7.5; 6.7 | — |
| SECONDARY Percentage of Subjects With Gain or Loss of 0 to 5 Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity Letters From Baseline to Week 52 and Baseline to Week 104 |
35; 30 | — |
| SECONDARY Mean Change in Central Retinal Thickness From Baseline to Week 52 and Baseline to Week 104. |
-7; 1 | — |
| SECONDARY Number of Subjects With no Clinically-relevant Diabetic Macular Edema (as Defined in the Protocol) on Spectral Domain Optical Coherence Tomography From Baseline to Week 52 and Baseline to Week 104. |
39; 29 | — |
| SECONDARY Number of Subjects With Stable, Worsened, or Improved Diabetic Retinopathy |
5; 46; 3; 15; 27; 4 | — |
| SECONDARY Number of Subjects That Receive Focal Laser Treatment. |
25; 27 | — |
| SECONDARY Mean Change in Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity Before and After Focal Laser Therapy |
0.4; 0.3 | — |
| SECONDARY Mean Change in Central Retinal Thickness Before and After First Focal Laser Treatment |
-8.5; -6.8 | — |
| SECONDARY Role of (Ultrawide-field, if Available) Fluorescein Angiography-determined Retinal Ischemia in Predicting Past and Future Anti-VEGF Treatment Burden |
— | — |
| SECONDARY Role of (Ultrawide-field, if Available) Fluorescein Angiography-determined Retinal Ischemia in Predicting Visual Outcomes |
— | — |
| SECONDARY Role of (Ultrawide-field, if Available) Fluorescein Angiography-determined Retinal Ischemia in Predicting Anatomic Outcomes |
— | — |
Eligibility Criteria
Inclusion Criteria
- A subject must meet the following criteria to be eligible for inclusion in the study:
- 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
- A subject who meets any of the following criteria will be excluded from the study:
- 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.
Data sourced from ClinicalTrials.gov (NCT02299336) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.