Neovascular age-related macular degeneration (AMD) MedDRA version: 13.1 Level: LLT Classification code 10064930 Term: Age-related macular degeneration System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: VEGF Trap-Eye
Product Code: 80418745
Pharmaceutical Form: Solution for injection
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pr
Sponsors
Bayer Schering Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed Informed Consent. 2. Men and women = 50 years of age. 3. Active primary subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye. 4. ETDRS best-corrected visual acuity of: 20/40 to 20/320 (letter score of 73 to 25) in the study eye. 5. Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures. 6. 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. Able to understand and willing to sign the informed consent form. 7. The area of CNV must occupy at least 50% of total lesion. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD, except dietary supplements or vitamins. 2. Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye. 3. Prior treatment with anti-VEGF agents in the study eye. • Prior treatment with anti-VEGF therapy in the study eye is not allowed • Prior treatment with anti-VEGF therapy in the fellow eye with an investigational agent (not approved, eg, bevacizumab) within the last 3 months prior to the first dose in the study, and such treatment will not be allowed during the study. Prior treatment with an approved anti-VEGF therapy in the fellow eye is allowed. • Prior systemic anti-VEGF therapy, investigational or approved, within the last 3 months prior to the first dose in the study, and such treatment will not be allowed during the study. 4. Total lesion size >12 disc areas (30.5 mm2, including blood, scars and neovascularization) as assessed by FA in the study eye. 5. Subretinal hemorrhages that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye. 6. Scar or fibrosis making up >50% of the total lesion in the study eye. 7. Scar, fibrosis, or atrophy involving the center of the fovea in the study eye. 8. Presence of retinal pigment, epithelial tears or rips involving the macula in the study eye. 9. History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye. 10. Presence of other causes of CNV in the study eye. 11. Prior vitrectomy in the study eye. 12. History of retinal detachment or treatment or surgery for retinal detachment in the study eye. 13. Any history of macular hole of stage 2 and above in the study eye. 14. Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of Day 1, as long as it is unlikely to interfere with the injection. 15. Prior trabeculectomy or other filtration surgery in the study eye. 16. Uncontrolled glaucoma (defined as intraocular pressure >=25 mmHg despite treatment with antiglaucoma medication) in the study eye. 17. Aphakia or psuedophakia with absence of posterior capsule (unless it occurred as a result of a yttrium aluminum garnet [YAG] posterior capsulotomy) in the study eye. 18. Previous therapeutic radiation in the region of the study eye. 19. History of corneal transplant or corneal dystrophy in the study eye. 20. Significant media opacities, including cataract, in the study eye which might interfere with visual acuity, assessment of toxicity or fundus photography. 21. History or clinical evidence of diabetic retinopathy, diabetic macular oedema or any retinal vascular disease other than AMD in either eye. 22. Active intraocular, extraocular and periocular inflammation or infection in either eye. 23. Any ocular or periocular infection within the last 2 weeks prior to screening in either eye. 24. Any history of uveitis in either eye. 25. Presence of Scleromalacia in either eye. 26. Any concurrent intraocular condition in the study eye that could require either medical or surgical intervention during the 96-week study period. 27. Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the subject safety or which otherwise may interfere with evaluation of efficacy or safety. 28. History of other dise
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of intravitreally (ITV) administered VEGF Trap-Eye compared to ranibizumab (in a non-inferiority paradigm) in preventing moderate vision loss in subjects with all subtypes of neovascular AMD.;Secondary Objective: To assess the safety and tolerability of repeated ITV administration of VEGF Trap-Eye in subjects with all subtypes of neovascular AMD for up to 2 years. To assess the effect of repeated ITV administration of VEGF Trap-Eye in vision-related quality of life (QOL) in subjects with all subtypes of neovascular AMD, as assessed using the NEI VFQ-25. To describe systemic exposure to the study drug. ;Primary end point(s): The proportion of subjects who maintain vision at Week 52, where a subject is classified as maintaining vision if the subject has lost fewer than 15 letters in the ETDRS letter score compared to baseline (ie, prevention of moderate vision loss). | — |
Countries
Austria, Czech Republic, France, Germany, Hungary, Italy, Latvia, Netherlands, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed