Clinically Significant Diabetic Macular EdemaPhase 4Endurance3NCT02734407
Long-Term Efficacy and Safety of Aflibercept Intravitreal Injections for the Treatment of Diabetic Macular Edema
A Phase 4 study testing Assigned Intervention and aflibercept 2.0 mg in people with Clinically Significant Diabetic Macular Edema, run by Retina-Vitreous Associates Medical Group.
Trial 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) endpoint. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinically Significant Diabetic Macular Edema
- What is being tested?
- Assigned Intervention and aflibercept 2.0 mg
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to 27 Sep 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official 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
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
Read the detailed description
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.
- Being tested
- Assigned Intervention, aflibercept 2.0 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assigned InterventionProcedure or surgery
Also called FLT
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.
aflibercept 2.0 mgDrug
Also called Eylea, VEGF-Trap
If a subject has recurrent CR-DME they will receive an IVT aflibercept injection
| Study group | Role | What they receive |
|---|---|---|
| Open-Label Arm | Experimental | 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. Receives: Procedure: Assigned Intervention; Drug: aflibercept 2.0 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of intravitreal aflibercept injections in 52 weeks
Measured: 12 months
Proportion of subjects receiving 0 aflibercept injections in 52 weeks
Measured: 12 months
Longer-term efficacy of aflibercept intravitreal injections as assessed by the mean number of injections in 52 weeks
Measured: 12 months
Safety of ongoing aflibercept intravitreal injections as assessed by the incidence and severity of ocular and systemic adverse events
Measured: 12 months
Secondary outcomes (7)
Vision Change
Mean change in visual acuity from baseline to week 52
Measured: 12 months
Vision loss
Proportion of subjects with gain or loss of 0 to 5 letters from baseline to week 52
Measured: 12 months
Change in central retinal thickness
Mean change in central retinal thickness from baseline to week 52
Measured: 12 months
Development of clinically relevant diabetic macular edema
Percentage of subjects with no clinically relevant diabetic macular edema seen on SD-OCT from baseline to week 52
Measured: 12 months
Evaluation of Diabetic Retinopathy (Proportion of subjects with stable, worsened, or improved diabetic retinopathy as identified by eye examination and imaging)
Proportion of subjects with stable, worsened, or improved diabetic retinopathy as identified by eye examination and imaging
Measured: 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)
Proportion of subjects that receive focal laser treatment and mean number of intravitreal aflibercept injections before and after receiving focal laser treatment
Measured: 12 months
Ocular and systemic adverse events
Incidence and severity of ocular and systemic adverse events as identified by eye examinations, imaging, and subject reporting
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startJan 2015
- Primary completion27 Sep 2017
- Study completion27 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinically Significant Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Retina-Vitreous Associates Medical Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Boyer, MD, Principal investigator, Retina-Vitreous Associates Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734407
- Sponsor's protocol ID
- Endurance 3
- Acronym
- Endurance3
- Status last verified
- Mar 2019
- First submitted
- 16 Dec 2014
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02734407
- Acronym / sponsor ID
- Endurance3 / Endurance 3
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Retina-Vitreous Associates Medical GroupUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- 27 Sep 2017 (actual)
- Study completion
- 27 Sep 2017 (actual)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-Label Arm | Experimental | Procedure: Assigned Intervention, Drug: aflibercept 2.0 mg2mg 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assigned InterventionAlso: FLTAll 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. | Procedure or surgery | Open-Label Arm |
| aflibercept 2.0 mgAlso: Eylea, VEGF-TrapIf a subject has recurrent CR-DME they will receive an IVT aflibercept injection | Drug | Open-Label Arm |
Primary outcome
Mean number of intravitreal aflibercept injections in 52 weeks
Time frame: 12 months
Proportion of subjects receiving 0 aflibercept injections in 52 weeks
Time frame: 12 months
Longer-term efficacy of aflibercept intravitreal injections as assessed by the mean number of injections in 52 weeks
Time frame: 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
7 secondary outcomes
Vision Change
Time frame: 12 months
Vision loss
Time frame: 12 months
Change in central retinal thickness
Time frame: 12 months
Development of clinically relevant diabetic macular edema
Time frame: 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
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
Ocular and systemic adverse events
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Boyer, MD principal investigator
Retina-Vitreous Associates Medical Group
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Assigned Intervention and aflibercept 2.0 mg in people with Clinically Significant Diabetic Macular Edema, run by Retina-Vitreous Associates Medical Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean number of intravitreal aflibercept injections in 52 weeks (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.