Efficacy and safety of the biosimilar ranibizumab FYB201 in comparison to Lucentis in patients with neovascular age-related macular degeneration (COLUMBUS-AMD)

Phase 1

• Conditions: Subfoveal neovascular age-related macular degeneration; MedDRA version: 19.1 Level: PT Classification code 10071129 Term: Neovascular age-related macular degeneration System Organ Class: 10015919 - Eye disorders; MedDRA version: 19.1 Level: LLT Classification code 10067791 Term: Wet macular degeneration System Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2015-001961-20-GB
• Lead Sponsor: Bioeq GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-11
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 500

Inclusion Criteria

1. Age = 50 years of either gender
2. Signed informed consent form must be obtained before any study-related procedure is performed
3. Willingness and ability to undertake all scheduled visits and assessments
4. Women must be postmenopausal or surgically sterile
5. Newly diagnosed, angiographically documented, primary active CNV lesion secondary to age-related macular degeneration (AMD)
6. Sufficiently clear ocular media and adequate pupillary dilation to permit good quality ocular 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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400

Exclusion Criteria

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 treatment 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified