Diabetic Macular EdemaPhase 4EnduranceNCT02297204
The Endurance 1 Trial
A Phase 4 study testing Focal Laser Treatment and aflibercept 2.0 mg in people with Diabetic Macular Edema, run by Northern California Retina Vitreous Associates.
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) end-point. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Focal Laser Treatment 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
- Nov 2014to 19 Mar 2018
- 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
- Women only
- 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 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.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Diabetic Macular Edema
- Being tested
- Focal Laser Treatment, aflibercept 2.0 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal Laser TreatmentProcedure 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. 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
If a subject has recurrent CR-DME they will receive an IVT aflibercept injection
| Study group | Role | What they receive |
|---|---|---|
| aflibercept | Experimental | 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. Receives: Procedure: Focal Laser Treatment; Drug: aflibercept 2.0 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for ongoing intravitreal aflibercept injections in the management of DME
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.
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
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
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
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 posted21 Nov 2014 (estimated)
- Study startNov 2014
- Primary completion13 Dec 2017
- Study completion19 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern California Retina Vitreous Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Principal investigator, Rahul Khurana, M.D., Northern California Retina Vitreous Associates
- Investigators
- Rahul Khurana, MD, Principal investigator, Northern California Retina Vitreous Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297204
- Sponsor's protocol ID
- REG-2014-11-006
- Acronym
- Endurance
- Status last verified
- Feb 2019
- First submitted
- 14 Nov 2014
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02297204
- Acronym / sponsor ID
- Endurance / REG-2014-11-006
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Northern California Retina Vitreous AssociatesUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Nov 2014
- Primary completion
- 13 Dec 2017 (actual)
- Study completion
- 19 Mar 2018 (actual)
- First posted
- 21 Nov 2014 (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) 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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aflibercept | Experimental | Procedure: Focal Laser Treatment, Drug: aflibercept 2.0 mg2mg, 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
- Female only
- 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 (4 listed)
- 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).
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 |
|---|---|---|
| Focal Laser TreatmentAlso: FLTAll 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. | Procedure or surgery | aflibercept |
| aflibercept 2.0 mgAlso: EyleaIf a subject has recurrent CR-DME they will receive an IVT aflibercept injection | Drug | aflibercept |
Primary outcome
Need for ongoing intravitreal aflibercept injections in the management of DME
Time frame: 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.
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
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
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
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 4 Feb 2019.
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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.
Rahul Khurana, MD principal investigator
Northern California Retina Vitreous Associates
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Focal Laser Treatment and aflibercept 2.0 mg in people with Diabetic Macular Edema, run by Northern California Retina Vitreous Associates.
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 4 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 4 Feb 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?
Need for ongoing intravitreal aflibercept injections in the management of DME (time frame: 12 months). 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 4 Feb 2019.