Effect of Vitrectomy on the Evolution of Refractory Diabetic Macular Edema

Diabetic Retinopathy Clinical Trial

— VITROMD  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03603990
• Other study ID #: YLR_2018_3
• Secondary ID: 2018-A00873-52
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: May 2020
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Angiopathies
• Diabetic Retinopathy
• Edema
• Macular Degeneration
• Macular Edema
• Retinal Disease
• Retinal Diseases

Intervention

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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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