The ‘wet’ form of age-related macular degeneration (AMD) is a disease which affects the central part of the retina (called the macula) at the back of the eye. The wet form of AMD is caused by choroidal neovascularisation (the abnormal growth of blood vessels under the macula), which may leak fluid and blood and cause swelling (Eylea SmPC) MedDRA version: 20.0 Level: LLT Classification code 10075568 Term: Wet age-related macular degeneration System Organ Class: 100000004853
Conditions
Interventions
Product Name: Aflibercept
Product Code: SOK583A1
Pharmaceutical Form: Solution for injection
INN or Proposed INN: AFLIBERCEPT
CAS Number: 862111-32-8
Current Sponsor code: SOK583A1
Other descriptive n
Sponsors
Hexal AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants eligible for inclusion in this study must meet all of the following criteria: 1. Signed informed consent must be obtained prior to participation in the study 2. Participants must be 50 years of age or older at Screening 3. Anti-VEGF treatment-naive patients for either eye and systemically 4. Study eye diagnosed with active CNV lesions secondary to AMD affecting the central subfield (including Retinal Angiomatous Proliferation lesions with a CNV component). Active CNV lesion is defined by the presence of leakage as evidenced by fluorescein angiography, and intra- or subretinal fluid as evidenced by optical coherence tomography, both confirmed by the CRC at Screening 5. Total area of CNV (including both classic and occult components) must comprise > 50% of the total lesion area in the study eye, confirmed by the CRC at Screening 6. BCVA between 73 and 38 letters, both inclusive, in the study eye at Screening and Baseline using ETDRS testing charts 7. Willing and able to comply with all study procedures, and be likely to complete the study 8. Clear ocular media and adequate pupil dilatation in both eyes to permit good quality photographic imaging 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 46 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 414
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria are not eligible for inclusion in this study. Ocular conditions and treatments: 1.Previous treatment with any anti-VEGF therapy in either eye or investigational drugs in study eye or fellow eye, at any time prior the Baseline 2.Participant has received any approved treatment for nAMD (other than vitamin and dietary supplements) in the study eye and at any time prior the Baseline 3.Presence of other causes of CNV, including diabetic retinopathy, pathologic myopia (spherical equivalent of –8 diopters or more negative, or axial length of 25 mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study eye 4.Any active intraocular or periocular infection or active intraocular inflammation (e.g infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in either eye at Screening or Baseline 5.Subfoveal fibrosis, atrophy, or scarring extending > 50% of total lesion area in the study eye as assessed by the Investigator at Screening and confirmed by the CRC prior to randomization 6.Subretinal hemorrhage that is = 50% of the total lesion area in the study eye, or if the subretinal hemorrhage involving the fovea is 1 or more disc areas (= 2.54 mm2 ) in size in the study eye, as assessed by FA and confirmed by the CRC 7.RPE rip/tear in the study eye at Screening or Baseline 8.Current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Baseline 9.History or evidence of the following, in the study eye: •Intraocular (including cataract surgery) or refractive surgery within the 90 day period prior to Baseline. The YAG posterior capsulotomy is allowed no later than 4 weeks prior to Screening •Previous penetrating keratoplasty or vitrectomy •Previous panretinal photocoagulation or photodynamic therapy •Previous submacular surgery or other surgical intervention for AMD •Retinal detachment or treatment or surgery for retinal detachment •Any history of macular hole of stage 2 and above •Prior trabeculectomy or other filtration surgery •Ocular trauma within the 6-months period prior to Baseline 10.History of hypersensitivity to any of the study treatments or its excipients, or clinically relevant sensitivity to fluorescein dye, as assessed by the Investigators 11.Uncontrolled glaucoma in the study eye defined as IOP > 25 mmHg on medication or according to Investigator’s judgment at Screening or Baseline 12.Aphakia and/or absence of the posterior capsule in the study eye at Screening or Baseline, unless it occurred as a result of a YAG posterior capsulotomy in association with prior posterior chamber intraocular lens implantation 13.Intra or periocular use of corticosteroids in the study eye during 180 days period prior to Baseline 14.Use of topical ocular corticosteroids in the study eye for 30 or more consecutive days within the 90 days period prior to Screening 15.Previous therapeutic radiation near the region of the study eye 16.Concomitant conditions or ocular disorders in the study eye, including media opacities, cataract and diabetic macular edema, at Screening or Baseline which could, in the opinion of the Investigator, prevent response to study treatment or may confound interpretation of study results (efficacy and safety), compromise visual acuity or require medical or surgical intervention during the course of the study 17.Presence of amblyopia, amaurosis o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate similar efficacy of SOK583A1 and Eylea EU in terms of BCVA;Secondary Objective: - To evaluate if the anatomical outcome of SOK583A1 is similar to Eylea EU - To evaluate if the efficacy of SOK583A1 is similar to Eylea EU in terms of BCVA - To evaluate if SOK583A1 is similar to Eylea EU in terms of safety - To evaluate if SOK583A1 is similar to Eylea EU in terms of immunogenicity - To evaluate the systemic exposure of SOK583A1 and Eylea EU in participants of the PK assessment ;Primary end point(s): Mean change from baseline in BCVA score using ETDRS testing charts ;Timepoint(s) of evaluation of this end point: Mean change from baseline in BCVA score using ETDRS testing charts at Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Mean change in CSFT using SD-OCT from Baseline • Mean change of CNV lesion size using FA from Baseline • Mean change from Baseline in BCVA score using EDTRS testing charts • Incidence of ocular and non-ocular AEs • Development of binding and neutralizing ADAs • Aflibercept concentration assessments ;Timepoint(s) of evaluation of this end point: • Mean change in CSFT using SD-OCT from Baseline to Week 1, 4, 8, 24 and 52 • Mean change of CNV lesion size using FA from Baseline to Week 8 and 52 • Mean change from Baseline in BCVA score using EDTRS testing charts at Week 24 and 52 • Incidence of ocular and non-ocular AEs over 52 weeks • Development of binding and neutralizing ADAs up to Week 52 • Aflibercept concentration assessments at Baseline (pre-dose) and 24 hours after the first and third injections | — |
Countries
Australia, Austria, Bulgaria, Czechia, Czech Republic, France, Germany, Hungary, Israel, Japan, Latvia, Lithuania, New Zealand, Poland, Portugal, Romania, Russian Federation, Slovakia, Spain, Ukraine, United States
Contacts
Public ContactClinical Trial Information Desk
Hexal AG
Outcome results
None listed