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Effect of Vitrectomy on the Evolution of Refractory Diabetic Macular Edema (VITROMD)

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ClinicalTrials.gov Identifier: NCT03603990
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary:

In case of bilateral non-tractional diabetic edema refractory to 6 months of anti-VEGF injections (anti Vascular endothelial growth factor injections), a randomization is done: one eye will receive the standard treatment (anti-VEGF injections, switch to another anti-VEGF drug, additional photocoagulation) and the other eye will receive vitrectomy.

After six months, in both groups, the patient may receive another treatment if needed : dexamethasone implant, laser photocoagulation, anti-VEGF or even vitrectomy in the non-vitrectomized eye


Condition or disease Intervention/treatment Phase
Edema Macular Edema Diabetic Retinopathy Macular Degeneration Diabetic Angiopathies Retinal Disease Procedure: Vitrectomy Procedure: Usual care Not Applicable

Detailed Description:

In case of bilateral non-tractional diabetic edema refractory to 6 months of anti-VEGF injections (anti Vascular endothelial growth factor injections), a randomization is done: one eye will receive the standard treatment (anti-VEGF injections, switch to another anti-VEGF drug, additional photocoagulation) and the other eye will receive vitrectomy.

After six months, in both groups, the patient may receive another treatment if needed : dexamethasone implant, laser photocoagulation, anti-VEGF or even vitrectomy in the non-vitrectomized eye


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective randomized open blinded end-point (PROBE) pragmatic study, in which patients act as their own control.
Masking: Single (Outcomes Assessor)
Masking Description: Although both the patient and the investigating physician will be aware of group assignment, the evaluation of the primary endpoint (visual acuity) will be performed by independent evaluators, unaware of the randomization group for each eye. The evaluation of the CSF thickness will be automatically recorded by the OCT and therefore will not be influenced by the eye's group.
Primary Purpose: Treatment
Official Title: Effect of Vitrectomy on the Evolution of Refractory Diabetic Macular Edema: a Randomized Pragmatic Controlled Study
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: Eye with vitrectomy
Eye with standard pars plana vitrectomy
Procedure: Vitrectomy
Standard pars plana vitrectomy

Active Comparator: Eye with usual care
Eye with usual care according to the investigator choice
Procedure: Usual care

In the complete absence of guidelines, usual care is given according to the investigator choice after discussion with the patient. It could include continuation of the same anti-VEGF drug, or switch to another approved anti-VEGF drug. The frequency of injections is also left to the appreciation of the investigator (a maximum of one injection per month, ie a maximum of 24 injections during the study). An additional macular photocoagulation is possible during the follow up.

After First Six Months : Therapies for DME may be given at the discretion of the investigator.

After six months of conventional treatment, the investigator may propose an implant of dexamethasone or even propose a vitrectomy if the results of surgery on the other eye seem encouraging.





Primary Outcome Measures :
  1. Visual acuity [ Time Frame: 6 months after vitrectomy ]
    The difference between the change in the score of visual acuity (between randomization and 6 months after treatment) for both eyes of each participant



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years
  • Type 1 or type 2 diabetes
  • Diabetic Macular Edema (DME) in both eyes (with ophthalmoscopic evidence of center-involved DME)
  • Glated haemoglobin (HbA1c) <12 % in the last 3 months before patient inclusion
  • Failure of medical treatment considered for both eyes 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
    • 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

Exclusion Criteria:

  • Any history of vitrectomy
  • Tractional DME: on OCT Optical Coherence Tomography), undetached posterior hyaloid membrane with anterior-posterior traction
  • Blood pressure > 180/110 (systolic above 180 OR diastolic above 110)
  • Intraocular pressure ≥ 25 mmHg
  • Exam evidence of external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis
  • Exam evidence of ocular toxoplasmosis
  • Aphakia
  • 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.).
  • 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.
  • 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.
  • 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.
  • History of cataract extraction within 3 months prior to enrollment
  • History of prior herpetic ocular infection
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03603990


Contacts
Contact: Laurence SALOMON 01.48.03.64.31 ext +33 lsalomon@for.paris
Contact: Yannick LE MER ylemer@for.paris

Locations
France
CHU Pellegrin Not yet recruiting
Bordeaux, France
Contact: Jean-François KOROBELNIK         
CHU de Dijon Not yet recruiting
Dijon, France
Contact: Catherine CREUZOT-GARCHER         
Hospices civils de Lyon Not yet recruiting
Lyon, France
Contact: Laurent KODJIKIAN         
CHU de Nantes Not yet recruiting
Nantes, France
Contact: Michel WEBER         
Fondation Ophtalmologique A de Rothschild Recruiting
Paris, France, 75019
Contact: Yannick LE MER       ylemer@for.paris   
Hôpital Lariboisière (APHP), Paris Not yet recruiting
Paris, France
Contact: Ramin TADAYONI         
CHU de Strasbourg Not yet recruiting
Strasbourg, France
Contact: David GAUCHER         
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
Principal Investigator: Yannick LE MER Fondation Ophtalmologique A. de Rothschild

Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03603990     History of Changes
Other Study ID Numbers: YLR_2018_3
2018-A00873-52 ( Other Identifier: IDRCB )
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
Edema
Macular Edema
Diabetic Retinopathy
Macular Degeneration
Diabetic Angiopathies
Retinal Disease
Signs and Symptoms
Vitrectomy

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Diabetic Angiopathies
Edema
Macular Degeneration
Macular Edema
Signs and Symptoms
Retinal Degeneration
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases