- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02734407
Long-Term Efficacy and Safety of Aflibercept Intravitreal Injections for the Treatment of Diabetic Macular Edema (Endurance3)
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
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:
|
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
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Endurance 3
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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