Neovascular (wet) age-related macular degeneration MedDRA version: 20.0 Level: PT Classification code 10071129 Term: Neovascular age-related macular degeneration System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Eylea 40mg/ml solution for injection
Product Name: Aflibercept
Product Code: BAY 86-5321
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Aflibercept
CAS Number: 862111-32-
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent and able to read (or if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member), understand, and willing to sign the ICF. 2. Men and women =50 years of age. 3. At treatment initiation, active macular neovascular lesions secondary to nAMD (Patients with polypoidal choroidal vasculopathy or retinal angiomatous proliferation are eligible to participate in the study, and their condition should be captured in the electronic case report form [eCRF]). 4. Treatment initiation with 3?×?monthly IVT aflibercept injections (Weeks?-16, -12, and -8 to planned study baseline visit) resulting in absence of any fluid at week?-8. 5. ETDRS BCVA of at least 25 letters (20/320 Snellen equivalent) in the study eye at screening visit. 6. Willing, committed, and able to return for all clinic visits and complete all study-related procedures. 7. Able to use the provided monitoring device and willing to perform 5 × weekly self-assessments in the Investigator’s opinion. 8. 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 ICF and 3 months after the last administration of study drug. 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 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 103
Exclusion criteria
Exclusion criteria: 1. Any contraindication to IVT anti-VEGF treatment or treatment with Eylea® as detailed in the Summary of Product Characteristics (SmPC). 2. Any prior ocular (in the study eye) or systemic treatment (including investigational agents) or surgery for nAMD, except the 3 × monthly IVT aflibercept injections required for treatment initiation and dietary supplements or vitamins. 3. Any presence of intraretinal and subretinal fluid. 4. Any ocular or systemic condition expected to interfere with study outcomes and procedures, including but not limited to: • Scar, fibrosis or other lesions (e.g., retinal pigment epithelium [RPE] tears, macular hole stage 2 or above and others) involving the center of the macula in the study eye. • Clinically relevant opacities or conditions involving the optic media including cataract, corneal dystrophies or s.p. corneal transplant in the study eye. • Uncontrolled glaucoma (defined as IOP =25 mm Hg despite treatment with antiglaucoma medication) in the study eye or prior trabeculectomy or other filtration surgery in the study eye. • Intraocular surgery, periocular surgery, or cataract surgery within 90 days before Day 1 in the study eye, except the IVT aflibercept injections required for treatment initiation and any history of vitrectomy, retinal radiation therapy, retinal detachment or treatment or surgery for retinal detachment in the study eye. • Aphakia or pseudophakia with absence of posterior capsule (unless as a result of an yttrium aluminum garnet posterior capsulotomy) in the study eye. 5. Participation as a patient in any clinical study within 12 weeks before screening. 6. Close affiliation with the investigational site; e.g., a close relative of the Investigator, dependent person (e.g., employee or student of the investigational site). 7. Previously screen failed patients for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether 2 mg intravitreal (IVT) aflibercept administered at a customized treatment interval (determined after the first extended treatment interval) is non-inferior to 2 mg IVT aflibercept administered according to a standard treat and extend (T&E) regimen (initiated after the first extended treatment interval) in patients with no fluid following treatment initiation for neovascular (wet) age-related macular degeneration (nAMD);Secondary Objective: 1. To assess treatment burden of 2 mg IVT aflibercept administered at a customized treatment interval compared with 2 mg IVT aflibercept administered according to a standard T&E regimen (initiated after the first extended treatment interval) in patients with no fluid following treatment initiation for nAMD 2. To evaluate the safety of aflibercept with proactive treatment intervals;Primary end point(s): Change in best-corrected visual acuity (BCVA) (early treatment diabetic retinopathy study [ETDRS] letters);Timepoint(s) of evaluation of this end point: From baseline to Week 36 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Number of IVT aflibercept injections per patient 2. Number of IVT aflibercept injections per patient 3. Number of patients achieving pre-defined treatment intervals (=4, =8, =10, =12¸ =14, and 16 weeks) 4. Change in BCVA (ETDRS letters) 5. Number of subjects with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs);Timepoint(s) of evaluation of this end point: 1. From baseline up to Week 52 2. From baseline up to Week 36 3. At Weeks 36 and 52 4. From baseline up to Week 52 5. From baseline up to Week 36 and Week 52 | — |
Countries
Canada, France, Germany, Spain, United Kingdom
Contacts
Public ContactBayer Clinical Trials Contact
Bayer AG
Outcome results
None listed