Diabetic Macular Edema (DME)Phase 4NCT02633852
Multicenter Study to Evaluate the Efficacy of Treat and Extend Regimen of Aflibercept (EYLEA) as a Second Line Treatment for Diabetic Macular Edema
A Phase 4 study testing Aflibercept in people with Diabetic Macular Edema (DME), run by Hadassah Medical Organization.
Trial summary
A 12-month, Multicenter Study to Evaluate the Efficacy of Treat and Extend Regimen (TER) of Aflibercept (EYLEA) 2mg /0.05 ml as a Second Line Treatment for Diabetic Macular Edema - TADI Study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema (DME)
- What is being tested?
- Aflibercept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 24 May 2016to 6 Sep 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
- Ophthalmic Inclusion Criteria
- Incomplete response to previous intravitreal treatment, defined as remaining of sub or intraretinal (or both) fluid involving the fovea per OCT after at least 6 monthly intravitreal injections and no more than 18 months of treatment (maximum 18 intravitreal injections). The last 3 injections must be up to 4-6 weeks apart. The interval from last treatment to day 0 treatment of the study should be up to 6 months. If there will be 10% or more of improvement in central macular sub-field thickness according to SD-OCT, in screening compared with examination 4-6 weeks following last bevacizumab injection patient cannot be recruited to the study. Patients that will have an increase in central thickness of more than 50 microns following 3 intravitreal injections will be allowed to participate in the study without the required need of 6 intravitreal injections.
- Central macular sub-field thickness according to SD-OCT of at least 300 micron (Heidelberg Spectralis OCT or equivalent).
- Best corrected visual acuity in the study eye 20/200 and better, .
- Clear ocular media and adequate pupillary dilatation to allow fundus imaging.
- Intraocular pressure (IOP) of 21 mmHg or less.
Who cannot join
- Ophthalmic Exclusion Criteria
- An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigmentabnormalities, dense sub-foveal hard exudates).
- An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.).
- History of pan-retinal photocoagulation or focal laser treatment within three months prior to enrollment or anticipated need for pan-retinal photocoagulation in the six months following enrollment.
- History of intraocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior three months or anticipated within the next six months following enrollment.
- General Exclusion Criteria
Show all 12Show fewer
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
- Any treatment with an investigational agent in the 60 days prior to trial entry for any condition.
- Known serious allergies to the fluorescein dye used in angiography (mild allergy amenable to treatment is allowable), or to the components of the aflibercept formulation.
- For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 24 months.Women who are potential study participants should be questioned about the potential for pregnancy. Investigator judgment is used to determine when a pregnancy test is needed.
- Stroke or Myocardial infraction within 6 months of trial entry. -
About this study
Official title: A 12-month, Multicenter Study to Evaluate the Efficacy of Treat and Extend Regimen (TER) of Aflibercept (EYLEA) 2mg /0.05 ml as a Second Line Treatment for Diabetic Macular Edema
A 12-month, Multicenter Study to Evaluate the Efficacy of Treat and Extend Regimen (TER) of Aflibercept (EYLEA) 2mg /0.05 ml as a Second Line Treatment for Diabetic Macular Edema - TADI Study
Read the detailed description
A prospective, multicenter, single arm study. The study group will be composed of both type 1 or 2 diabetes mellitus patients with center involving DME. Patients with partial or incomplete response to first-line Bevacizumab (Avastin) treatment of at least 4 monthly intravitreal injections and no longer than 12 months of treatment (maximum 12 injections ) the last 3 injections must be up to 4-6 weeks . Only one eye of each patients can be recruited to the study (fellow eye will receive standard of care treatment).
The study eye will receive intravitreal injection of aflibercept 2mg/0.05ml at enrolment (day 0). The next follow up visit will be 4 weeks later. At any visit, if sub- or intra-retinal (or both) fluid is present or if central macular sub-field thickness according to SD-OCT of larger than 300 micron (Heidelberg Spectralis OCT or equivalent), the patient will receive intravitreal injection of aflibercept 2mg/0.05ml and treatment interval will remain 4 weeks. In case that there will not be resolution or improvement (define as decrease in central macular sub-field thickness of 10% or more from the previous visit or gain of one ETDRS line or more), the intravitreal injection of aflibercept will be discontinued after 6 monthly injections and the patient will be followed every 4 weeks. If there will be worsening of 10% or more in macular thickness and/or loss of one EDTRS line or more of acuity following treatment discontinuation then injections will be resumed. In cases when there will be no sub- or intra-retinal fluid on OCT 4 weeks after an injections, a treat and extend regimen (TER) will be applied.
At any time point there is an option for rescue treatment if there will be worsening of more than 10% or increase of 50 micron in macular thickness and loss of one EDTRS line (5 letters) or more of acuity, or per the decision of the investigator.
Patients will receive injection of aflibercept 2mg/0.05ml, and the follow up interval will be extended by2 weeks. Maximal treatment interval will be 12 weeks . At any point where sub- or intra-retinal (or both) fluid will appear after the TER regimen was initiated, the interval between visits and treatments will be reduced back to previous interval which obtained a fluid free macula. The follow up period will be 52 weeks.
After 6 months, focal laser phothocoagulation can be added if needed.
- Conditions
- Diabetic Macular Edema (DME)
- Being tested
- Aflibercept
- Keywords
- Diabetic Macular Edema (DME), Aflibercept (EYLEA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfliberceptDrug
Also called EYLEA
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept (EYLEA) 2mg /0.05 ml | Experimental | Aflibercept (EYLEA) 2mg /0.05 ml Receives: Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
macular thickness changes
Assess macular thickness changes following second line therapy with aflibercept using treat-and-extend algorithm
Measured: At week 52
Secondary outcomes (3)
visual acuity
Evaluate the change in visual acuity
Measured: At week 52
treatment/injection number required
Assess treatment/injection number required
Measured: At week 52
progression of diabetic retinopathy
Assess progression of diabetic retinopathy
Measured: At week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study start24 May 2016
- Primary completion28 Aug 2018
- Study completion6 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular Edema (DME)Studies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633852
- Sponsor's protocol ID
- CHOTADI- HMO-CTIL
- Status last verified
- Sep 2017
- First submitted
- 25 Nov 2015
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-month, Multicenter Study to Evaluate the Efficacy of Treat and Extend Regimen (TER) of Aflibercept (EYLEA) 2mg /0.05 ml as a Second Line Treatment for Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT02633852
- Acronym / sponsor ID
- CHOTADI- HMO-CTIL
- Conditions
- Diabetic Macular Edema (DME)
- Keywords
- Diabetic Macular Edema (DME), Aflibercept (EYLEA)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 24 May 2016 (actual)
- Primary completion
- 28 Aug 2018 (actual)
- Study completion
- 6 Sep 2018 (actual)
- First posted
- 17 Dec 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.
A 12-month, Multicenter Study to Evaluate the Efficacy of Treat and Extend Regimen (TER) of Aflibercept (EYLEA) 2mg /0.05 ml as a Second Line Treatment for Diabetic Macular Edema - TADI Study
Detailed description
A prospective, multicenter, single arm study. The study group will be composed of both type 1 or 2 diabetes mellitus patients with center involving DME. Patients with partial or incomplete response to first-line Bevacizumab (Avastin) treatment of at least 4 monthly intravitreal injections and no longer than 12 months of treatment (maximum 12 injections ) the last 3 injections must be up to 4-6 weeks . Only one eye of each patients can be recruited to the study (fellow eye will receive standard of care treatment).
The study eye will receive intravitreal injection of aflibercept 2mg/0.05ml at enrolment (day 0). The next follow up visit will be 4 weeks later. At any visit, if sub- or intra-retinal (or both) fluid is present or if central macular sub-field thickness according to SD-OCT of larger than 300 micron (Heidelberg Spectralis OCT or equivalent), the patient will receive intravitreal injection of aflibercept 2mg/0.05ml and treatment interval will remain 4 weeks. In case that there will not be resolution or improvement (define as decrease in central macular sub-field thickness of 10% or more from the previous visit or gain of one ETDRS line or more), the intravitreal injection of aflibercept will be discontinued after 6 monthly injections and the patient will be followed every 4 weeks. If there will be worsening of 10% or more in macular thickness and/or loss of one EDTRS line or more of acuity following treatment discontinuation then injections will be resumed. In cases when there will be no sub- or intra-retinal fluid on OCT 4 weeks after an injections, a treat and extend regimen (TER) will be applied.
At any time point there is an option for rescue treatment if there will be worsening of more than 10% or increase of 50 micron in macular thickness and loss of one EDTRS line (5 letters) or more of acuity, or per the decision of the investigator.
Patients will receive injection of aflibercept 2mg/0.05ml, and the follow up interval will be extended by2 weeks. Maximal treatment interval will be 12 weeks . At any point where sub- or intra-retinal (or both) fluid will appear after the TER regimen was initiated, the interval between visits and treatments will be reduced back to previous interval which obtained a fluid free macula. The follow up period will be 52 weeks.
After 6 months, focal laser phothocoagulation can be added if needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aflibercept (EYLEA) 2mg /0.05 ml | Experimental | Drug: AfliberceptAflibercept (EYLEA) 2mg /0.05 ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ophthalmic Inclusion Criteria
- Incomplete response to previous intravitreal treatment, defined as remaining of sub or intraretinal (or both) fluid involving the fovea per OCT after at least 6 monthly intravitreal injections and no more than 18 months of treatment (maximum 18 intravitreal injections). The last 3 injections must be up to 4-6 weeks apart. The interval from last treatment to day 0 treatment of the study should be up to 6 months. If there will be 10% or more of improvement in central macular sub-field thickness according to SD-OCT, in screening compared with examination 4-6 weeks following last bevacizumab injection patient cannot be recruited to the study. Patients that will have an increase in central thickness of more than 50 microns following 3 intravitreal injections will be allowed to participate in the study without the required need of 6 intravitreal injections.
- Central macular sub-field thickness according to SD-OCT of at least 300 micron (Heidelberg Spectralis OCT or equivalent).
- Best corrected visual acuity in the study eye 20/200 and better, .
- Clear ocular media and adequate pupillary dilatation to allow fundus imaging.
Key exclusion criteria (12 listed)
- Ophthalmic Exclusion Criteria
- An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigmentabnormalities, dense sub-foveal hard exudates).
- An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.).
- History of pan-retinal photocoagulation or focal laser treatment within three months prior to enrollment or anticipated need for pan-retinal photocoagulation in the six months following enrollment.
- History of intraocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior three months or anticipated within the next six months following enrollment.
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 |
|---|---|---|
| AfliberceptAlso: EYLEA | Drug | Aflibercept (EYLEA) 2mg /0.05 ml |
Primary outcome
macular thickness changes
Time frame: At week 52
Assess macular thickness changes following second line therapy with aflibercept using treat-and-extend algorithm
3 secondary outcomes
visual acuity
Time frame: At week 52
treatment/injection number required
Time frame: At week 52
progression of diabetic retinopathy
Time frame: At 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 14 Sep 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aflibercept in people with Diabetic Macular Edema (DME), run by Hadassah Medical Organization.
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 12 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 14 Sep 2018. 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?
macular thickness changes (time frame: At 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 14 Sep 2018.