Impact of EU-label-treatment with aflibercept on vision-related quality of life and safety in subjects with diabetic macular edema.
- Conditions
- Diabetic macular edema (DME)MedDRA version: 18.0Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 10015919 - Eye disordersMedDRA version: 18.0Level: SOCClassification code 10015919Term: Eye disordersSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2014-005119-17-IT
- Lead Sponsor
- Bayer HealthCare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 490
1. Adults of either sex, = 18 years of age
2. Willingness and ability to comply with clinic visits and study-related procedures
3. Women and men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the informed consent form and 3 months after the last administration of study drug.
The definition of adequate contraception will be based on the judgment of the investigator and on local requirements.
Acceptable methods of contraception include, but are not limited to, (i) condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intra-uterine device; (iv) hormone-based contraception.
Subjects must agree to utilize two reliable and acceptable methods of contraception simultaneously.
Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential.
4. Negative pregnancy test (urine or serum; women of childbearing potential only)
5. Written informed consent
6. Type 1 or 2 diabetes mellitus
7. Diagnosis of DME secondary to diabetes mellitus involving the center of the macula (defined as the area of the center subfield on OCT) in the study eye
8. Decrease in vision determined to be primarily the result of DME in the study eye
9. BCVA in the study eye of ETDRS letter score 73 to 24
(This corresponds to a Snellen equivalent of approximately 20/40 to 20/320)
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 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 240
1. Previous treatment with anti-angiogenic drugs in study eye (e.g. pegaptanib sodium, bevacizumab, ranibizumab) within the last 12 weeks
2. History of vitreoretinal surgery and/or including scleral buckling in the study eye
3. Use of long acting steroids, either periocular or intraocular, in the preceding 120 days
4. Any ocular or periocular infection in the preceding 4 weeks
5. Active proliferative diabetic retinopathy (PDR), current iris neovascularization, vitreous hemorrhage, or tractional retinal detachment in the study eye
6. Aphakia in the study eye
7. Cataract surgery within 90 days
8. Yttrium-aluminum-garnet capsulotomy in the study eye within 30 days
9. Any other intraocular surgery within 90 days
10. Ocular inflammation (including trace or above) or history of uveitis in the study eye
11. Vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or on OCT that is thought to affect central vision
12. Pre-retinal fibrosis involving the macula of the study eye
13. Structural damage to the center of the macula in the study eye that was likely to preclude improvement in BCVA following the resolution of macular edema including atrophy of the retinal pigment epithelium, subretinal fibrosis or scar, significant macular ischemia or organized hard exudates
14. Filtration surgery for glaucoma in the past or likely to be needed in the future on the study eye
15. Intraocular pressure (IOP) = 25 mmHg in the study eye
16. Concurrent disease in the study eye, other than DME, that could compromise VA, require medical or surgical intervention during the study period, or could confound interpretation of the results (including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause)
17. Myopia of a spherical equivalent prior to any possible refractive or cataract surgery of = 8 diopters
18. Administration of systemic anti angiogenic agents within 180 days
19. Uncontrolled diabetes mellitus in the opinion of the investigator
20. Uncontrolled blood pressure (defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 95 mmHg while subject is sitting confirmed in two separate measurements)
21. Presence of any contraindications indicated in the EU commission/locally approved label for aflibercept
22. Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
23. Allergy to fluorescein
24. Current treatment for a serious systemic infection
25. History of either cerebral vascular accident and/or myocardial infarction within 180 days
26. Renal failure requiring dialysis or renal transplant
27. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, might affect interpretation of the results of the study, or renders the subject at high risk for treatment complications
28. Significant media opacities, including cataract, in the study eye that interferes with visual acuity, fundus photography or OCT imaging.
29. Breast-feeding women
30. Previous assignment to treatment during this study
31. Concomitant participation in another clinical study with investigational medicinal product(s).
32. Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g. employee or student of
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the change in quality of life (NEI VFQ 25) in subjects with DME during the first year of treatment with aflibercept according to the EU label for DME;Secondary Objective: • To assess further the safety and tolerability of aflibercept in this population<br>• To assess the change in the diabetic retinopathy severity score (DRSS) from baseline to Week 52<br>• To support patient recruitment for the EMA-requested post-approval efficacy study in DME<br>;Primary end point(s): The change from baseline to Week 52 in the NEI VFQ 25 total score.;Timepoint(s) of evaluation of this end point: Week 52
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Efficacy assessments:<br>The change from baseline to Week 52 in the NEI VFQ 25 near activities subscale.<br>The change from baseline to Week 52 in the NEI VFQ 25 distant activities subscale.<br>The change from baseline to Week 52 in BCVA (ETDRS letter score).<br>The change from baseline to Week 52 in CRT measured by OCT.<br>Safety assessments:<br>Intraocular pressure and adverse events every 4 weeks.<br>Vital signs at baseline and at week 52.;Timepoint(s) of evaluation of this end point: Baseline (vital signs), every 4 weeks (intraocular pressure) and Week 52 (efficacy assessments and vital signs).