Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With Wet Age-Related Macular Degeneration (AMD)
Macular Degeneration
About this trial
This is an interventional treatment trial for Macular Degeneration focused on measuring Neovascular Age-Related Macular Degeneration
Eligibility Criteria
Inclusion Criteria: Subfoveal CNV secondary to AMD. Central retinal (including lesion) thickness ≥ 300 µm as measured by Optical Coherence Tomography (OCT). Early Treatment of Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity of 73 letters to 34 letters. Exclusion Criteria: History of any vitreous hemorrhage within 4 weeks prior to Day 1. Aphakia. Significant subfoveal atrophy or scarring. Prior treatment with the following in the study eye: Subfoveal thermal laser therapy. Submacular surgery or other surgical intervention for the treatment of AMD. Extrafoveal laser coagulation treatment within 12 weeks prior to Day 1. Photodynamic therapy (PDT) within 12 weeks prior to Visit 2 (Day 1). Pegaptanib sodium (Macugen) within 8 weeks of Visit 2 (Day 1). Juxtascleral steroids or anecortave acetate within 24 weeks (6 months) prior to Visit 2 (Day 1). Intravitreal administration of triamcinolone acetonide or other steroids within 24 weeks prior to Visit 2 (Day 1), unless no visible residue of drug substance can be seen in the vitreous cavity using indirect ophthalmoscopy. Prior systemic or intravitreal treatment with VEGF Trap, ranibizumab (Lucentis) or bevacizumab (Avastin). Presence of any other condition or laboratory abnormality, which, in the opinion of the Investigator, would interfere with the assessment of disease status/progression or jeopardize the patient's appropriate participation in this Phase II study.
Sites / Locations
- Associated Retina Consultants
- Retina Centers, PC
- Retina Vitreous Associates Medical Group
- Loma Linda University Health Care
- Southeast Retina Center
- University of Chicago
- Midwest Eye Institute
- Johns Hopkins Hospital School of Medicine
- Ophthalmic Consultants of Boston
- New England Retina Consultants PC
- Charlotte Eye, Ear, Nose & Throat Asssociates
- Dean A. McGee Eye Institute
- Retina Northwest PC
- Retina Diagnostic and Treatment Assoc., LLC
- Black Hills Regional Eye Institute
- Retina-Vitreous Associates, P.C.
- Vitreoretinal Consultants Scurlock Tower Texas Medical Center
- Medical Center Ophthamology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q4
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q12
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q4
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q12
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 4.0mg q12