Effect of Vitrectomy on the Evolution of Refractory Diabetic Macular Edema

NCT03603990 | Withdrawn

• 2 other identifiers: YLR_2018_32018-A00873-52
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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.

Procedure: Usual care

Interventions

Vitrectomy PROCEDURE

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

Vitrectomy

Usual care PROCEDURE

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.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

MeSH Terms

Conditions

Edema; Macular Edema; Diabetic Retinopathy; Macular Degeneration; Diabetic Angiopathies; Retinal Diseases; Signs and Symptoms

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Retinal Degeneration; Eye Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Yannick LE MER

  Fondation Ophtalmologique A. de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Prospective randomized open blinded end-point (PROBE) pragmatic study

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: July 27, 2018
• Study Start: September 1, 2018
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: May 14, 2020

Record last verified: 2020-05