VITROMD: Effect of Vitrectomy on the Evolution of Refractory Diabetic Macular Edema

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03603990

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief 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, 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).

Condition or Disease	Intervention/Treatment	Phase
Edema Macular Edema Diabetic Retinopathy Macular Degeneration Diabetic Angiopathies Retinal Disease	Procedure: Vitrectomy Procedure: Usual care	N/A

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

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective randomized open blinded end-point (PROBE) pragmatic studyProspective randomized open blinded end-point (PROBE) pragmatic study

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 group.

Primary Purpose:

Treatment

Official Title:

Effect of Vitrectomy on the Evolution of Refractory Diabetic Macular Edema: a Randomized Pragmatic Controlled Study

Actual Study Start Date :

Sep 1, 2018

Actual Primary Completion Date :

Mar 1, 2020

Actual Study Completion Date :

Mar 1, 2020

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Visual acuity [6 months after randomization]
The difference between the change in the score of visual acuity between randomization and 6 months after treatment, between groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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