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Effect of Vitrectomy on the Evolution of Refractory Diabetic Macular Edema

NCT03603990 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-05-14

No results posted yet for this study

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

Interventions

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

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.

Sponsors & Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

    lead NETWORK

Principal Investigators

  • Yannick LE MER · Fondation Ophtalmologique A. de Rothschild

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2020-03-01
Completion
2020-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03603990 on ClinicalTrials.gov