Investigation of the change of vision-related quality of life in subjects treated with aflibercept according to EU label for DME
- Conditions
- Diabetic macular edema (DME)MedDRA version: 20.1Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 10015919 - Eye disordersMedDRA version: 20.0Level: SOCClassification code 10015919Term: Eye disordersSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2014-005119-17-FR
- Lead Sponsor
- Bayer 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 a method of highly effective contraception (as defined by the Clinical Trials Facilitation group [CTFG] from 15 SEP 2014):
• Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
- oral
- intravaginal
- transdermal
• Progestogen-only hormonal contraception associated with inhibition of ovulation:
- oral
- injectable
- implantable
• Intrauterine device (IUD)
• Intrauterine hormone-releasing system (IUS)
• Bilateral tubal occlusion
• Vasectomised partner
• Sexual abstinence
Alternatively women and men of reproductive potential can also use two acceptable methods of contraception (as defined by the Clinical Trials Facilitation group [CTFG] from 15 SEP 2014) simultaneously:
• Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action
• Male or female condom with or without spermicide
• Cap, diaphragm or sponge with spermicide
Contraception has to be used from signing the informed consent form until 3 months after the last administration of study drug. 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. Signed 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
A subject must not meet any of the following exclusion criteria, at
screening and baseline as applicable, to be eligible for enrollment into this study.
Ocular exclusion criteria (study eye)
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. Prior treatment of the study eye with
- Use of long acting steroids, either periocular or intraocular, in the preceding 120 days or
- Iluvien® intravitreal implant at any time
4. Active proliferative diabetic retinopathy (PDR), current iris neovascularization, vitreous hemorrhage, or tractional retinal detachment in the study eye
5. Aphakia in the study eye
6. Cataract surgery within 90 days before first study treatment in the study eye
7. Yttrium-aluminum-garnet capsulotomy in the study eye within 30 days before first study treatment
8. Any other intraocular surgery within 90 days of first study treatment in the study eye
9. Ocular inflammation (including trace or above) or history of uveitis in the study eye
10. Vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or on OCT that is thought to affect central vision
11. Pre-retinal fibrosis involving the macula of the study eye
12. 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
13. Filtration surgery for glaucoma in the past or likely to be needed in the future on the study eye
14. Uncontrolled glaucoma (defined as intraocular pressure [IOP] > 25 mmHg despite treatment with antiglaucoma medication) in the study eye
15. 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 advanced glaucoma retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause)
16. Significant media opacities, including cataract, in the study eye that interferes with visual acuity, fundus photography or OCT imaging.
17. Myopia of a spherical equivalent prior to any possible refractive or cataract surgery of = 8 diopters in the study eye
Ocular exclusion criteria (either eye)
18. Any ocular or periocular infection in the preceding 4 weeks in either eye
19. Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
Ocular and systemic exclusion criteria
20. Presence of any contraindications indicated in the EU commission/locally approved label for aflibercept
Systemic exclusion criteria
21. Administration of systemic anti angiogenic agents within 180 days before first study treatment
22. Uncontrolled diabetes mellitus, as defined by hemoglobin (Hb)A1c > 12.0%
23. 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)
24. Allergy or hypersensitivity to fluorescein
25. Current treatment for a serious systemic infection
26. History of either cerebral vascular accident and/or myocardial infarction within 180 days before first study treatment
27. Rena
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>Proportion of subjects progressing to = 61 ETDRS diabetic retinopathy severity scale (DRSS) as assessed by FP;Timepoint(s) of evaluation of this end point: Baseline (vital signs), every 4 weeks (intraocular pressure) and Week 52 (efficacy assessments and vital signs).