Multicenter Study to Evaluate the Efficacy of Treat and Extend Regimen of Aflibercept (EYLEA) as a Second Line Treatment for Diabetic Macular Edema

Diabetic Macular Edema (DME) Clinical Trial

Official title: A 12-month, Multicenter Study to Evaluate the Efficacy of Treat and Extend Regimen (TER) of Aflibercept (EYLEA) 2mg /0.05 ml as a Second Line Treatment for Diabetic Macular Edema

Status Completed

Clinical Trial Summary

A 12-month, Multicenter Study to Evaluate the Efficacy of Treat and Extend Regimen (TER) of Aflibercept (EYLEA) 2mg /0.05 ml as a Second Line Treatment for Diabetic Macular Edema - TADI Study

Clinical Trial Description

A prospective, multicenter, single arm study. The study group will be composed of both type 1 or 2 diabetes mellitus patients with center involving DME. Patients with partial or incomplete response to first-line Bevacizumab (Avastin) treatment of at least 4 monthly intravitreal injections and no longer than 12 months of treatment (maximum 12 injections ) the last 3 injections must be up to 4-6 weeks . Only one eye of each patients can be recruited to the study (fellow eye will receive standard of care treatment).

The study eye will receive intravitreal injection of aflibercept 2mg/0.05ml at enrolment (day 0). The next follow up visit will be 4 weeks later. At any visit, if sub- or intra-retinal (or both) fluid is present or if central macular sub-field thickness according to SD-OCT of larger than 300 micron (Heidelberg Spectralis OCT or equivalent), the patient will receive intravitreal injection of aflibercept 2mg/0.05ml and treatment interval will remain 4 weeks. In case that there will not be resolution or improvement (define as decrease in central macular sub-field thickness of 10% or more from the previous visit or gain of one ETDRS line or more), the intravitreal injection of aflibercept will be discontinued after 6 monthly injections and the patient will be followed every 4 weeks. If there will be worsening of 10% or more in macular thickness and/or loss of one EDTRS line or more of acuity following treatment discontinuation then injections will be resumed. In cases when there will be no sub- or intra-retinal fluid on OCT 4 weeks after an injections, a treat and extend regimen (TER) will be applied.

At any time point there is an option for rescue treatment if there will be worsening of more than 10% or increase of 50 micron in macular thickness and loss of one EDTRS line (5 letters) or more of acuity, or per the decision of the investigator.

Patients will receive injection of aflibercept 2mg/0.05ml, and the follow up interval will be extended by2 weeks. Maximal treatment interval will be 12 weeks . At any point where sub- or intra-retinal (or both) fluid will appear after the TER regimen was initiated, the interval between visits and treatments will be reduced back to previous interval which obtained a fluid free macula. The follow up period will be 52 weeks.

After 6 months, focal laser phothocoagulation can be added if needed. ;

Related Conditions & MeSH terms

• Diabetic Macular Edema (DME)
• Edema
• Macular Edema

• NCT number: NCT02633852
• Study type: Interventional
• Source: Hadassah Medical Organization
• Status: Completed
• Phase: Phase 4
• Start date: May 24, 2016
• Completion date: September 6, 2018