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

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).

Study Overview

• Status: Withdrawn
• Conditions: Diabetic Angiopathies; Macular Degeneration; Edema; Diabetic Retinopathy; Macular Edema; Retinal Disease
• Intervention / Treatment: Procedure: Vitrectomy; Procedure: Usual care

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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
  • 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Vitrectomy; 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	Procedure: 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
ACTIVE_COMPARATOR: Usual care; 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.	Procedure: Usual care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	The difference between the change in the score of visual acuity between randomization and 6 months after treatment, between groups	6 months after randomization

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Investigators: Principal Investigator: Yannick LE MER, Fondation Ophtalmologique A. de Rothschild

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2018
• Primary Completion (ACTUAL): March 1, 2020
• Study Completion (ACTUAL): March 1, 2020

Study Registration Dates

• First Submitted: July 19, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (ACTUAL): July 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 14, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Vitrectomy; Edema; Diabetic Angiopathies; Retinal Disease; Diabetic Retinopathy; Signs and Symptoms; Macular Edema; Macular Degeneration
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Retinal Degeneration; Macular Degeneration; Retinal Diseases; Diabetic Retinopathy; Macular Edema; Edema; Diabetic Angiopathies
• Other Study ID Numbers: YLR_2018_3; 2018-A00873-52 (OTHER: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No