EUCTR2018-004486-13-SKActive, not recruitingPhase 1
A Randomized, Phase 3, Double-masked, Parallel-group, Multicenter Study to Compare Efficacy and Safety of QL1205 Versus Lucentis® in Subjects With Neovascular Age-related Macular Degeneration
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 580
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Willingness and ability to undertake all scheduled visits and assessments as judged by the investigator
- •2. Age = 50 years at Screening
- •3. Males, or females of nonchildbearing potential (eg, permanently sterilized or postmenopausal [defined as 12 months with no menses without an alternative medical cause before Screening])
- •4. Newly diagnosed, treatment-naive, active subfoveal CNV lesion secondary to AMD in the study eye. Active CNV means presence of leakage as evidenced by fluorescein angiography (FA) and intra- or sub-retinal fluid as evidenced by optical coherence tomography (OCT) that is confirmed by the central reading center during Screening (before randomization)
- •5. Total lesion area = 9.0 disc areas in size (including blood, scars, and neovascularization) as assessed by FA in the study eye and confirmed by the central reading center before randomization
- •6. The area of CNV must be = 50% of the total lesion area in the study eye confirmed by the central reading center before randomization
- •7. Best corrected visual acuity of 20/40 to 20/200 in the study eye using ETDRS chart (= 73 and = 34 ETDRS letters) at Screening and at Day 1 before randomization
- •8. Fellow eye should not be expected to need any anti-vascular endothelial growth factor (VEGF) treatment for the duration of study participation
- •9. Written informed consent form (ICF) obtained before any study-related procedures are performed
- •10. Male subjects of reproductive potential must be willing to completely abstain from sexual intercourse or agree to use an appropriate method of contraception from the time of signing the ICF and for the duration of study participation through 3 months after the last dose of study drug. See Appendix 17.1 for examples of acceptable contraception. (The investigator and each subject will determine the appropriate method of contraception for the subject during the participation in the study.)
- •a. A man of reproductive potential is any man who has not been surgically sterilized (eg, has not undergone bilateral orchiectomy or vasectomy)
- •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 290
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 290
Exclusion Criteria
- •1. Previous ocular treatment/surgery for wAMD in either eye
- •2. Previous intravitreal treatment/vitreal surgery in either eye
- •3. Any previous intravitreal anti-VEGF treatment (eg, bevacizumab, aflibercept, ranibizumab) in either eye
- •4. Any previous systemic anti-VEGF treatment
- •5. Sub- or intraretinal hemorrhage involving the fovea in the study eye of 50% or more of the total lesion area assessed by FA and confirmed by the central reading center (before randomization)
- •6. Subfoveal fibrosis or atrophy in the study eye assessed by FA and confirmed by the central reading center (before randomization)
- •7. Scarring exceeding 50% of total lesion size in the study eye and confirmed by the central reading center (before randomization)
- •8. Choroidal neovascularization in either eye due to nonAMD causes assessed by FA and confirmed by the central reading center (before randomization)
- •9. Retinal pigment epithelial tear involving the macula in the study eye as assessed by FA and confirmed by the central reading center (before randomization)
- •10. Any concurrent intraocular condition in the study eye (eg, cataract or diabetic retinopathy) that, in the opinion of the investigator, could require treatment during the study period to prevent or treat loss of visual acuity
- •11. Other intraocular surgery (including cataract surgery) or periocular surgery in the study eye within 3 months before randomization, except for eyelid surgery within 30 days before randomization
- •12. Corneal transplant in the study eye
- •13. Active or recent (within 28 days before randomization) intraocular, extraocular, and periocular inflammation or infection in either eye, including conjunctivitis, keratitis, scleritis, or endophthalmitis
- •14. Current vitreous hemorrhage in the study eye
- •15. History of retinal detachment in the study eye
- •16. History of macular hole in the study eye
- •17. History of idiopathic or autoimmune-associated uveitis in either eye
- •18. Aphakia or absence of the posterior capsule in the study eye, unless it occurred as a result of a Yttrium Aluminium Garnet posterior capsulotomy in association with prior posterior chamber intraocular lens implantation
- •19. Presence of advanced glaucoma or optic neuropathy that involves or threatens the central visual field in the study eye
- •20. History of glaucoma filtering surgery in the study eye
- •21. Uncontrolled ocular hypertension in the study eye, defined as intraocular pressure = 25 mm Hg despite treatment with anti-glaucoma medication
- •22. Spherical equivalent of the refractive error in the study eye demonstrating more than 8 diopters of myopia
- •23. Contraindication for Lucentis® (hypersensitivity to ranibizumab or to any of the excipients, active or suspected ocular or periocular infection, or active severe intraocular inflammation), or known allergic reactions to any ingredients of QL1205
- •24. Current treatment for active systemic infection
- •25. Subjects with known history of seropositivity for hepatitis B, hepatitis C antibody, HIV antibody, syphilis tests, or any immunodeficiency and/or immunosuppressive disease or active systemic infection. Seropositivity for hepatitis B is defined as (1) positive for hepatitis B surface antigen and (2) positive for hepatitis B virus DNA
- •26. Reasonable suspicion of a disease or condition that might render the subject at high risk of treatment complications or affect interpretation of the study results (as judged by the investigator), such as uncontrolled hypertension (systolic blood press
Investigators
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