diabetic macular edema MedDRA version: 15.0 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Avastin
Product Name: Avastin
Product Code: EU/1/04/300/001
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: BEVACIZUMAB
CAS Number: 216974-75-3
Concentratio
Sponsors
The Rotterdam Eye Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years. 2. Able to read and sign the written informed consent. 3. Diagnosis of DME, based on ETDRS criteria and confirmed by macular edema on optical coherence tomography (OCT, Heidelberg Spectralis), defined as CFT = 340 micron (see Section 7.1 for argumentation for chosen cut-off value). 4. VA loss due to DME, with VA being between 45 and 85 letters as measured on ETDRS chart (Snellen decimal equivalent: 0.08 – 0.63). 5. If both eyes are eligible, the eye with the highest CFT will be selected as the study eye. If both eyes have equal CFT, the eye with the most recent record of presence of DME will be selected as the study eye. The fellow eye will receive treatment according to the current standard of care at the investigator’s discretion. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 336
Exclusion criteria
Exclusion criteria: 1. Previous laser photocoagulation therapy within the last 6 months. 2. Previous anti-VEGF therapy (Avastin, Lucentis, Eylea, or any investigational anti-VEGF drug) within the last 3 months. 3. Previous subtenon’s or intravitreal triamcinolone injection within the last 6 months. 4. Steroid implants of any kind within the last 3 years. 5. Macular ischemia confirmed by fluorescein angiography (FA). 6. Vitreoretinal traction or epiretinal membranes with the potential of macular structural damage and function loss, confirmed by OCT. 7. Other eye conditions affecting VA prognosis, including pre-existent (deep) amblyopia. 8. Any ocular surgery/intervention within last three months before enrollment. 9. Any ocular surgery/intervention anticipated during the course of the study. 10. Ocular opacities hampering adequate imaging of the posterior pole. 11. Poor control of DM with glycated hemoglobin (HbA1c) of = 86% in last 6 months. 12. Allergy to fluorescein or anti-VEGF, or any of its preservatives. 13. Pregnancy. 14. Non-Caucasian or Asian descent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether laser photocoagulation prolongs treatment effect of anti-VEGF for DME.;Secondary Objective: Not applicable.;Primary end point(s): Proportion of failures at 72 weeks. Definition of failure: > 50 micron increase in central foveal thickness compared to week 24.;Timepoint(s) of evaluation of this end point: Baseline, 24 weeks, 72 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Central foveal thickness. Visual acuity. ;Timepoint(s) of evaluation of this end point: Baseline, week 24, week 72. | — |
Countries
Netherlands
Contacts
Public ContactRotterdam Ophthalmic Institute
The Rotterdam Eye Hospital
Outcome results
None listed