Efficacy and safety of the biosimilar ranibizumab FYB201 in comparison toLucentis in patients with neovascular age-related macular degeneration(COLUMBUS-AMD)
- Conditions
- Subfoveal neovascular age-related macular degenerationMedDRA version: 20.0Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersMedDRA version: 20.1Level: LLTClassification code 10067791Term: Wet macular degenerationSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2015-001961-20-IT
- Lead Sponsor
- BIOEQ GMBH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 722
1. Age = 50 years of either gender
2. Signed informed consent form must be obtained before any studyrelated procedure is performed
3. Willingness and ability to undertake all scheduled visits and
assessments
4. Women must be postmenopausal (= 12 months of non-therapyinduced
amenorrhea) or surgically sterile (with documentation in the
patient's medical records)
5. Newly diagnosed, angiographically documented, primary active CNV
lesion secondary to age-related macular degeneration (AMD)
a. All subtypes of wet AMD CNV lesions are eligible (classic, occult, some
classical component, retinal angiomatous proliferation lesions). Active
primary CNV must be subfoveal or juxtafoveal with subfoveal component
related to CNV activity (such as sub- or intraretinal fluid by spectral
domain optical coherence tomography (SD-OCT) or retinal pigment
epithelium (RPE) detachment)
b. Total area of whole lesion must be equal or less than 12 disc areas
c. Total CNV area encompasses equal or more than 50% of total lesion
area based on fluorescein angiography (FA), including all subtypes of
wet AMD
6. Sufficiently clear ocular media and adequate pupillary dilation to
permit good quality ocular imaging
7. BCVA in the study eye, determined by standardized Early Treatment
Diabetic Retinopathy Study (ETDRS) testing, between 20/32 (0.63) and
20/100 (0.2) Snellen equivalent
8. FCP retinal thickness at Screening = 350 µm. (FCP thickness is defined
as the distance between the vitreoretinal interface and Bruch's
membrane at the geometric center of the fovea)
9. BCVA in the fellow eye, determined by standardized ETDRS testing, at
least 20/100 (0.2) Snellen equivalent
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400
1. Employees of clinical study sites, individuals directly involved with the conduct of the study or immediate family members thereof, prisoners, and persons who are legally institutionalized.
2. Any prior treatment with IVT anti-vascular endothelial growth factor (VEGF) agent (e.g., bevacizumab, aflibercept, ranibizumab) in either eye
3. History of vitrectomy, macular surgery or other surgical intervention for AMD in the study eye
4. History of IVT or periocular injections of corticosteroids or device implantation within six months prior to Screening in the study eye
5. Prior treatment with verteporfin (photodynamic therapy), transpupillary thermotherapy, radiation therapy, or retinal laser treatment (e.g. focal laser photocoagulation) in the study eye
6. Topical ocular corticosteroids administered for at least 30 consecutive days within three months prior to Screening
7. Any other intraocular surgery (including cataract surgery) in the study eye within three months prior to Screening.
8. Sub- or intra-retinal hemorrhage that comprises more than 50% of the entire lesion in the study eye
9. Fibrosis or atrophy involving the center of the fovea or influencing central visual function in the study eye
10. CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia.
11. Retinal pigment epithelial tear involving the macula in the study eye
12. History of full-thickness macular hole (stage 2 and above by clinical examination or full thickness macular hole by SD-OCT imaging of any size) in the study eye
13. History of retinal detachment in the study eye
14. Current vitreous hemorrhage in the study eye
15. Spherical equivalent of the refractive error in the study eye demonstrating more than 8 diopters of myopia
16. For patients who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye cannot exceed 8 diopters of myopia
17. History of corneal transplant in the study eye
18. Aphakia in the study eye. Absence of an intact posterior capsule is allowed if it occurred as a result of YAG laser posterior capsulotomy in association with prior posterior chamber intraocular lens (IOL) implantation
19. Active or recent (within 4 weeks) intraocular inflammation of clinical significance in the study eye such as active infections of the anterior segment (excluding mild blepharitis) including conjunctivitis, keratitis, scleritis, uveitis or endophthalmitis
20. Uncontrolled hypertension or glaucoma in the study eye (defined as intraocular pressure [IOP] =30 mm Hg, despite treatment with anti-glaucomatous medication)
21. Ocular disorders in the study eye (i.e. retinal detachment, pre-retinal membrane of the macula or cataract with significant impact on visual acuity) at the time of enrollment that may confound interpretation of study results and compromise visual acuity
22. Any concurrent intraocular condition in the study eye (e.g. glaucoma, cataract or diabetic retinopathy) that, in the opinion of the Investigator, would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results.
23. Use of other investigational drugs (excluding vitamins, minerals) within 30 days or 5 half-lives from Screening, whichever is longer
24. Any type of advanced, severe or unstable disease, including any medical condition (controlled or uncontrolled) that could be expected
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method