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

• Status: Completed
• Trial end date: 2018-09-06
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hadassah Medical Organization
• Collaborator: Bayer
• Treatments: Aflibercept

Criteria

Inclusion Criteria:

Ophthalmic Inclusion Criteria

1. Incomplete response to previous intravitreal treatment, defined as remaining of sub or intraretinal (or both) fluid involving the fovea per OCT after at least 6 monthly intravitreal injections and no more than 18 months of treatment (maximum 18 intravitreal injections). The last 3 injections must be up to 4-6 weeks apart. The interval from last treatment to day 0 treatment of the study should be up to 6 months. If there will be 10% or more of improvement in central macular sub-field thickness according to SD-OCT, in screening compared with examination 4-6 weeks following last bevacizumab injection patient cannot be recruited to the study. Patients that will have an increase in central thickness of more than 50 microns following 3 intravitreal injections will be allowed to participate in the study without the required need of 6 intravitreal injections.

2. Central macular sub-field thickness according to SD-OCT of at least 300 micron (Heidelberg Spectralis OCT or equivalent).

3. Best corrected visual acuity in the study eye 20/200 and better, .

4. Clear ocular media and adequate pupillary dilatation to allow fundus imaging.

5. Intraocular pressure (IOP) of 21 mmHg or less.

Exclusion Criteria:

Ophthalmic Exclusion Criteria

1. An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigmentabnormalities, dense sub-foveal hard exudates).

2. An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.).

3. History of pan-retinal photocoagulation or focal laser treatment within three months prior to enrollment or anticipated need for pan-retinal photocoagulation in the six months following enrollment.

4. History of intraocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior three months or anticipated within the next six months following enrollment.

General Exclusion Criteria

1. Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.

2. A 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).

3. Any treatment with an investigational agent in the 60 days prior to trial entry for any condition.

4. Known serious allergies to the fluorescein dye used in angiography (mild allergy amenable to treatment is allowable), or to the components of the aflibercept formulation.

5. For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 24 months.Women who are potential study participants should be questioned about the potential for pregnancy. Investigator judgment is used to determine when a pregnancy test is needed.

6. Stroke or Myocardial infraction within 6 months of trial entry. -