Trial Condition(s):
Managing neovascular (known as "wet") age-related macular degeneration over 2 years using different treatment schedules of 2 mg intravitreal aflibercept injected in the eye (ARIES)
17508
Not Available
This study aims to evaluate the optimal use, efficacy, and safety of a Treat-and-Extend regimen with aflibercept in subjects with nAMD.
- Men and women ≥ 50 years of age. - Active primary subfoveal CNV lesions secondary to nAMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye. Patients with polypoidal choroidal vasculopathy or retinal angiomatous proliferation are eligible to participate in the study, and their condition should be captured in the eCRF. - ETDRS BCVA of 73 to 25 letters (20/40 to 20/320 Snellen equivalent) in the study eye. - The area of CNV must occupy at least 50% of the total lesion.
- Any prior ocular (in the study eye) or systemic treatment or surgery for nAMD, except dietary supplements or vitamins. - Any prior or concomitant therapy with another investigational agent to treat nAMD in the study eye. - Prior treatment with anti-VEGF agents as follows: - 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, e.g. bevacizumab) within the last 3 months before the first dose in the study. Such treatment will also 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 before the first dose in the study, and such treatment will not be allowed during the study. - Total lesion size >12 disc areas (30.5 mm2, including blood, scars and neovascularization) as assessed by FA in the study eye. - Subretinal hemorrhages that are 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. (If the blood is under the fovea, then the fovea must be surrounded by 270 degrees by visible CNV). - Scar or fibrosis making up >50% of the total lesion in the study eye. - Scar, fibrosis, or atrophy involving the center of the fovea in the study eye. - Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
Locations | |
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Locations Investigative Site Ottawa, Canada, K2B7E9 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Boisbriand, Canada, J7H1S6 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Padova, Italy, 35128 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Roma, Italy, 00198 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Milano, Italy, 20157 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Hannover, Germany, 30625 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Köln, Germany, 50924 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Tübingen, Germany, 72076 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Freiburg, Germany, 79106 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Sulzbach, Germany, 66280 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Bonn, Germany, 53105 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Oviedo, Spain, 33012 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Zaragoza, Spain, 50009 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Madrid, Spain | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Westmead, Australia, 2145 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Sydney, Australia, 2000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site East Melbourne, Australia, 3002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Liverpool, United Kingdom, L7 8XP | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Bristol, United Kingdom, BS12LX | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site London, United Kingdom, EC1V2PD | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Oxford, United Kingdom, OX3 9DU | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Launceston, Australia, 7249 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site CRETEIL CEDEX, France, 94010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Nice cedex 1, France, 06006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Canterbury, United Kingdom, CT1 3NG | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Chemnitz, Germany, 09116 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Hamilton, Canada, L8G 5E4 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Berlin, Germany, 10713 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Strathfield, Australia, 2135 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Pecs, Hungary, 7621 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Budapest, Hungary, 1085 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Debrecen, Hungary, 4032 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Budapest, Hungary, 1133 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Budapest, Hungary, 1106 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Budapest, Hungary, 1115 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Budapest, Hungary, 1062 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Szombathely, Hungary, 9700 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Budapest, Hungary, 1125 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Managing neovascular age-related macular degeneration (nAMD) over 2 years with a Treat and Extend (T&E) regimen of 2 mg intravitreal aflibercept - a randomized, open-label, active-controlled, parallel-group phase IV/IIIb study (ARIES)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2