EdemaVITROMDNCT03603990
Effect of Vitrectomy on the Evolution of Refractory Diabetic Macular Edema
A study testing Vitrectomy in people with Edema and Macular Edema, run by Fondation Ophtalmologique Adolphe de Rothschild.
Trial summary
For patients with at least one eye with non-tractional diabetic edema refractory to 6 months of anti-VEGF injections (anti Vascular endothelial growth factor injections), a randomization is done: one group of patients will receive the standard treatment (anti-VEGF injections, switch to another anti-VEGF drug… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edema, Macular Edema, Diabetic Retinopathy
- What is being tested?
- Vitrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 1 Mar 2020
- Phase
- Interventional
- 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
- Age ≥18 years
- Type 1 or type 2 diabetes
- At least one eye with Diabetic Macular Edema (DME) (with ophthalmoscopic evidence of center-involved DME) and Failure of medical treatment considered and conducted during at least 6 months defined as follows:
- At least 4 intravitreal anti-VEGF injections given within the prior 6 months
- ETDRS score ≤ 78 and ≥24 (approximate Snellen equivalent 20/32 to 20/320)
- OCT (Optical Coherence Tomography) CSF (Central Subfield) thickness value (microns): Heidelberg Spectralis: ≥305 in women; ≥320 in men
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- Less than 5 letters gain in visual acuity (VA) after the initial Anti-VEGF treatment
- Less than 25% decrease of CMT (Central Macular Thickness) after the initial Anti-VEGF treatment
- Glated haemoglobin (HbA1c) <12 % in the last 3 months before patient inclusion
Who cannot join
- Any history of vitrectomy for the included eye
- Tractional DME: on OCT Optical Coherence Tomography), undetached posterior hyaloid membrane with anterior-posterior traction for the included eye
- Blood pressure > 180/110 (systolic above 180 OR diastolic above 110)
- Intraocular pressure ≥ 25 mmHg for the included eye
- Exam evidence of external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis for the included eye
- Exam evidence of ocular toxoplasmosis for the included eye
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- Aphakia for the included eye
- Ocular condition with visual acuity loss that, in the opinion of the investigator, would not improve from resolution of macular edema (e.g. foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, non-retinal condition, etc.) for the included eye
- 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).
- Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 1 month prior to enrollment
- History of macular laser photocoagulation within 3 months prior to enrollment for the included eye
- History of panretinal (scatter) photocoagulation (PRP) within 3 months prior to enrollment or anticipated need for PRP in the 6 months following enrollment into run-in phase for the included eye
- History of major ocular surgery (including scleral buckle, any intraocular surgery, etc.) within prior 3 months or anticipated within the next 6 months following enrollment for the included eye
- History of cataract extraction within 3 months prior to enrollment for the included eye
- History of prior herpetic ocular infection for the included eye
- Initiation of intensive insulin treatment (a pump or multiple daily injections) within 4 months prior to inclusion or plans to do so in the next 4 months.
- Steroid, anti-VEGF or pro-VEGF systemic treatment within 3 months prior to inclusion or anticipated use during the study
- History of chronic renal failure requiring dialysis or kidney transplant.
- Participation in an investigational trial that involved treatment with any drug that has not received regulatory approval for the indication being studied within 1 month of enrollment.
- For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next year.
- Patient expected to move out of the area of the clinical center to an area not covered by another clinical center during the next year
About this study
Official title: Effect of Vitrectomy on the Evolution of Refractory Diabetic Macular Edema: a Randomized Pragmatic Controlled Study
For patients with at least one eye with non-tractional diabetic edema refractory to 6 months of anti-VEGF injections (anti Vascular endothelial growth factor injections), a randomization is done: one group of patients will receive the standard treatment (anti-VEGF injections, switch to another anti-VEGF drug, additional photocoagulation or any other treatment except vitrectomy during the first 6 months after the randomisation) and the other group of patients will receive vitrectomy (with only additional photocoagulation during the first 6 months, then any treatment from 6 months after the randomization).
Read the detailed description
In case both eyes present refractory diabetic macular edema (DME) and are eligible, the eye with the worst DME will be included and randomized.
- Conditions
- Edema, Macular Edema, Diabetic Retinopathy, Macular Degeneration, Diabetic Angiopathies, Retinal Disease
- Being tested
- Vitrectomy, Usual care
- Keywords
- Edema, Macular Edema, Diabetic Retinopathy, Macular Degeneration, Diabetic Angiopathies, Retinal Disease, Signs and Symptoms, Vitrectomy
- Medical subject headings
- Edema, Macular Edema, Diabetic Retinopathy, Macular Degeneration, Diabetic Angiopathies, Retinal Diseases, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitrectomyProcedure or surgery
During the first 6 month :Only Panretinal photocoagulation(if high-risk PDR or rubeosis iridis) may be given.
After First Six Months : All therapies for DME may be given at the discretion of the investigator
Usual careProcedure or surgery
Patients with usual care according to the investigator choice :
During the first 6 month : All therapies for DME may be given at the discretion of the investigator during the study, except a vitrectomy.
After First Six Months : All therapies for DME may be given at the discretion of the investigator, including a vitrectomy.
| Study group | Role | What they receive |
|---|---|---|
| Vitrectomy | Experimental | Patient with standard pars plana vitrectomy
During the first 6 month :Only Panretinal photocoagulation(if high-risk PDR or rubeosis iridis) may be given.
After First Six Months : All therapies for DME may be given at the discretion of the investigator Receives: Procedure: Vitrectomy |
| Usual care | Active comparator | Patients with usual care according to the investigator choice :
During the first 6 month : All therapies for DME may be given at the discretion of the investigator during the study, except a vitrectomy.
After First Six Months : All therapies for DME may be given at the discretion of the investigator, including a vitrectomy. Receives: Procedure: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
The difference between the change in the score of visual acuity between randomization and 6 months after treatment, between groups
Measured: 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start1 Sep 2018
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Why it stopped: Inclusion difficulties, despite significant changes to inclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdemaStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized open blinded end-point (PROBE) pragmatic study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Yannick LE MER, Principal investigator, Fondation Ophtalmologique A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603990
- Sponsor's protocol ID
- YLR_2018_3
- Other IDs
- 2018-A00873-52
- Acronym
- VITROMD
- Status last verified
- May 2020
- First submitted
- 19 Jul 2018
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitrectomy on the Evolution of Refractory Diabetic Macular Edema: a Randomized Pragmatic Controlled Study
- ClinicalTrials.gov ID
- NCT03603990
- Acronym / sponsor ID
- VITROMD / YLR_2018_3
- Conditions
- Edema, Macular Edema, Diabetic Retinopathy, Macular Degeneration, Diabetic Angiopathies, Retinal Disease
- Keywords
- Edema, Macular Edema, Diabetic Retinopathy, Macular Degeneration, Diabetic Angiopathies, Retinal Disease, Signs and Symptoms, Vitrectomy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inclusion difficulties, despite significant changes to inclusion criteria
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 27 Jul 2018 (actual)
- 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.
For patients with at least one eye with non-tractional diabetic edema refractory to 6 months of anti-VEGF injections (anti Vascular endothelial growth factor injections), a randomization is done: one group of patients will receive the standard treatment (anti-VEGF injections, switch to another anti-VEGF drug, additional photocoagulation or any other treatment except vitrectomy during the first 6 months after the randomisation) and the other group of patients will receive vitrectomy (with only additional photocoagulation during the first 6 months, then any treatment from 6 months after the randomization).
Detailed description
In case both eyes present refractory diabetic macular edema (DME) and are eligible, the eye with the worst DME will be included and randomized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized open blinded end-point (PROBE) pragmatic study
| Arm | Type | Receives |
|---|---|---|
| Vitrectomy | Experimental | Procedure: VitrectomyPatient with standard pars plana vitrectomy During the first 6 month :Only Panretinal photocoagulation(if high-risk PDR or rubeosis iridis) may be given. After First Six Months : All therapies for DME may be given at the discretion of the investigator |
| Usual care | Active comparator | Procedure: Usual carePatients with usual care according to the investigator choice : During the first 6 month : All therapies for DME may be given at the discretion of the investigator during the study, except a vitrectomy. After First Six Months : All therapies for DME may be given at the discretion of the investigator, including a vitrectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years
- Type 1 or type 2 diabetes
- At least one eye with Diabetic Macular Edema (DME) (with ophthalmoscopic evidence of center-involved DME) and Failure of medical treatment considered and conducted during at least 6 months defined as follows:
- Glated haemoglobin (HbA1c) <12 % in the last 3 months before patient inclusion
Key exclusion criteria (21 listed)
- Any history of vitrectomy for the included eye
- Tractional DME: on OCT Optical Coherence Tomography), undetached posterior hyaloid membrane with anterior-posterior traction for the included eye
- Blood pressure > 180/110 (systolic above 180 OR diastolic above 110)
- Intraocular pressure ≥ 25 mmHg for the included eye
- Exam evidence of external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis for the included eye
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 |
|---|---|---|
| VitrectomyDuring the first 6 month :Only Panretinal photocoagulation(if high-risk PDR or rubeosis iridis) may be given. After First Six Months : All therapies for DME may be given at the discretion of the investigator | Procedure or surgery | Vitrectomy |
| Usual carePatients with usual care according to the investigator choice : During the first 6 month : All therapies for DME may be given at the discretion of the investigator during the study, except a vitrectomy. After First Six Months : All therapies for DME may be given at the discretion of the investigator, including a vitrectomy. | Procedure or surgery | Usual care |
Primary outcome
Visual acuity
Time frame: 6 months after randomization
The difference between the change in the score of visual acuity between randomization and 6 months after treatment, between groups
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
Yannick LE MER principal investigator
Fondation Ophtalmologique A. de Rothschild
Questions about this trial
What is this clinical trial studying?
A study testing Vitrectomy in people with Edema and Macular Edema, run by Fondation Ophtalmologique Adolphe de Rothschild.
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 9 inclusion and 21 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: withdrawn, as of the sponsor's last update on 14 May 2020. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Visual acuity (time frame: 6 months after randomization). 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 May 2020.