Cystoid Macular EdemaPhase 4EVADENCT02392364
Variable Interval Versus Set Interval Aflibercept for DME
A Phase 4 study testing Intravitreal Aflibercept Injection in people with Cystoid Macular Edema and Diabetic Macular Edema, run by California Retina Consultants at 2 sites in United States.
Trial summary
The purpose of this study is to compare the safety and efficacy of intravitreal Eylea injections at a set interval, versus a variable dosing schedule (likely longer than one month), based on a specific individual's disease progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystoid Macular Edema, Diabetic Macular Edema
- What is being tested?
- Intravitreal Aflibercept Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Apr 2015to 15 Nov 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years and older with Type 1 or Type 2 diabetes mellitus
- Patients with diabetic macular edema involving the center of the macular in the study eye (CST must measure at least 350µm on Heidelberg SDOCT, or 333µm on Cirrus SDOCT)
- Decrease in vision determined to be primarily due to DME in the study eye
- BCVA ETDRS letter score 78 to 24 (20/32 to 20/320) in the study eye
- Willing and able to comply with clinical visits and study related procedures
- Willing and able to provide signed informed consent
Who cannot join
- History of vitreoretinal surgery in the study eye
- Laser photocoagulation (panretinal or macular) in the study eye within 90 days of baseline
- Previous use of intraocular or periocular corticosteroids in the study eye within 90 days of baseline
- History of intravitreal anti-VEGF treatments in the study within 90days prior to baseline (not including prior intravitreal aflibercept injection [see exclusion criteria #5])
- Any history of intravitreal aflibercept
- Active proliferative diabetic retinopathy (PDR) in the study eye
Show all 28Show fewer
- History of idiopathic or autoimmune uveitis in the study eye
- Cataract surgery in the study eye within 90 days of baseline
- Aphakia in the study eye
- Yttrium aluminum garnet (YAG) capsulotomy in the study eye within 30 days of baseline
- Any intraocular surgery in the study eye within 90 days of day 1
- Vitreomacular traction or epiretinal membrane in the study eye that is thought to affect central vision
- Current iris neovascularization, vitreous hemorrhage, or traction retinal detachment in the study eye
- Pre-retinal fibrosis involving the macula in the study eye
- Uncontrolled glaucoma (defined as any patient who has had filtration surgery in the past, or likely to need filtration surgery in the future, or has IOP ≥30mmHg)
- Myopia of a spherical equivalent prior to any possible refractive or cataract surgery of ≥-8 diopters
- Concurrent disease in the study eye, other than DME, that could compromise BCVA, require medical or surgical intervention during the study period, or could confound interpretation of the results (including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause)
- Ocular media of insufficient quality to obtain fundus and SDOCT images
- Current treatment for a systemic infection
- Administration of systemic anti-angiogenic agents within 180 days of baseline
- Uncontrolled diabetes mellitus, in the opinion of the investigator
- Uncontrolled blood pressure (define as systolic >180mmHg, or diastolic >110mmHg while patient is sitting)
- History of CVA or MI within 180 days of baseline
- Renal failure requiring dialysis or renal transplant
- Known serious allergy to fluorescein
- Participation in an investigational study within 30 days prior to baseline that involved treatment with any drug (excluding vitamins and minerals) or device
- Any women who are pregnant, breast-feeding, or attempting to become pregnant
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
California Retina Consultants - Bakersfield
Bakersfield, California, 93039
California Retina Consultants - Santa Barbara Office
Santa Barbara, California, 93103
About this study
Official title: Treat and Extend Versus Dosing Every Eight Weeks With Intravitreal Aflibercept Injections for the Treatment of Diabetic Macular Edema (EVADE Study)
The purpose of this study is to compare the safety and efficacy of intravitreal Eylea injections at a set interval, versus a variable dosing schedule (likely longer than one month), based on a specific individual's disease progression. There will be approximately 50 men and women at least 18 years of age, diagnosed with type 1 or type 2 diabetes, taking part in this study at 5 locations in the United States.
- Conditions
- Cystoid Macular Edema, Diabetic Macular Edema
- Being tested
- Intravitreal Aflibercept Injection
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal Aflibercept InjectionDrug
| Study group | Role | What they receive |
|---|---|---|
| Variable Treatment Dosing Arm | Active comparator | Group 1 will receive injections every 4 weeks until diabetic macular edema on the OCT is decreased and stable. At that point, the length of time between injections may increase, depending on how the study eye is doing. The interval between study eye treatments may maintain, increase, or decrease once the variable treatment dosing has begun. This will be determined by an algorithm designed into a computer program Receives: Drug: Intravitreal Aflibercept Injection |
| Monthly Treatment Arm | Active comparator | Group 2 will receive 5 intravitreal injections, monthly, for the first 5 months of the study. After those initial injections, visits/treatment will be every 8 weeks. Receives: Drug: Intravitreal Aflibercept Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA Change
Change in mean BCVA from baseline to week 52
Measured: Week 0 to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study start15 Apr 2015
- Primary completion15 Nov 2018
- Study completion15 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystoid 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Retina Consultants
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Dilsher S Dhoot, MD, Principal investigator, California Retina Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392364
- Sponsor's protocol ID
- 2014-01-CRC
- Acronym
- EVADE
- Status last verified
- Jan 2019
- First submitted
- 2 Mar 2015
- Last updated
- 3 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treat and Extend Versus Dosing Every Eight Weeks With Intravitreal Aflibercept Injections for the Treatment of Diabetic Macular Edema (EVADE Study)
- ClinicalTrials.gov ID
- NCT02392364
- Acronym / sponsor ID
- EVADE / 2014-01-CRC
- Conditions
- Cystoid Macular Edema, Diabetic Macular Edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- California Retina ConsultantsUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 15 Apr 2015 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 19 Mar 2015 (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 purpose of this study is to compare the safety and efficacy of intravitreal Eylea injections at a set interval, versus a variable dosing schedule (likely longer than one month), based on a specific individual's disease progression. There will be approximately 50 men and women at least 18 years of age, diagnosed with type 1 or type 2 diabetes, taking part in this study at 5 locations in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Variable Treatment Dosing Arm | Active comparator | Drug: Intravitreal Aflibercept InjectionGroup 1 will receive injections every 4 weeks until diabetic macular edema on the OCT is decreased and stable. At that point, the length of time between injections may increase, depending on how the study eye is doing. The interval between study eye treatments may maintain, increase, or decrease once the variable treatment dosing has begun. This will be determined by an algorithm designed into a computer program |
| Monthly Treatment Arm | Active comparator | Drug: Intravitreal Aflibercept InjectionGroup 2 will receive 5 intravitreal injections, monthly, for the first 5 months of the study. After those initial injections, visits/treatment will be every 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults 18 years and older with Type 1 or Type 2 diabetes mellitus
- Patients with diabetic macular edema involving the center of the macular in the study eye (CST must measure at least 350µm on Heidelberg SDOCT, or 333µm on Cirrus SDOCT)
- Decrease in vision determined to be primarily due to DME in the study eye
- BCVA ETDRS letter score 78 to 24 (20/32 to 20/320) in the study eye
- Willing and able to comply with clinical visits and study related procedures
Key exclusion criteria (28 listed)
- History of vitreoretinal surgery in the study eye
- Laser photocoagulation (panretinal or macular) in the study eye within 90 days of baseline
- Previous use of intraocular or periocular corticosteroids in the study eye within 90 days of baseline
- History of intravitreal anti-VEGF treatments in the study within 90days prior to baseline (not including prior intravitreal aflibercept injection [see exclusion criteria #5])
- Any history of intravitreal aflibercept
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 |
|---|---|---|
| Intravitreal Aflibercept Injection | Drug | Monthly Treatment Arm, Variable Treatment Dosing Arm |
Primary outcome
BCVA Change
Time frame: Week 0 to Week 52
Change in mean BCVA from baseline to week 52
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 3 Jan 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.
Dilsher S Dhoot, MD principal investigator
California Retina Consultants
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravitreal Aflibercept Injection in people with Cystoid Macular Edema and Diabetic Macular Edema, run by California Retina Consultants at 2 sites in United States.
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 6 inclusion and 28 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 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
BCVA Change (time frame: Week 0 to Week 52). 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 3 Jan 2019.