Last updated on May 2019

Systemic VEGF Protein Dynamics Following Intravitreal Injections of Ranibizumab Versus Aflibercept in Patients With Neovascular Age-related Macular Degeneration

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Age-Related Macular Degeneration
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    Visual impairment predominantly due to neovascular AMD.
    Active, newly diagnosed, untreated, angiographically documented, CNV lesion (i.e.
    leakage on fluorescein angiography plus intraretinal, subretinal or sub-RPE fluid on
    OCT) secondary to neovascular AMD in line with SmPC of ranibizumab and aflibercept

You may not be eligible for this study if the following are true:

  • Stroke or myocardial infarction less than 3 months prior to screening.
    Presence of uncontrolled systolic blood pressure or diastolic blood pressure
    Type 1 or Type 2 diabetes mellitus
    Use of any systemic anti-VEGF drugs
    Use of systemic or inhaled corticosteroids for at least 30 consecutive days within 3
    months prior to screening.
    Women who are pregnant or breast feeding or who are menstruating and capable of
    becoming pregnant* and not practicing a medically approved method of contraception
    For either eye:
    Any active periocular or ocular infection or inflammation
    Uncontrolled glaucoma
    Neovascularization of the iris or neovascular glaucoma
    History of treatment with any anti-angiogenic drugs
    For study eye:
    Atrophy or fibrosis involving the center of the fovea at the time of screening or
    Cataract (if causing significant visual impairment), planned cataract surgery during
    the study period, vitrectomy, aphakia, glaucoma surgery, severe vitreous hemorrhage,
    rhegmatogenous retinal detachment, proliferative retinopathy or choroidal
    neovascularization of any other cause than wAMD
    Irreversible structural damage within 0.5 disc diameter of the center of the macula
    Any intraocular procedure (including cataract surgery, Yttrium-Aluminum-Garnet
    capsulotomy) within 3 months prior to baseline or anticipated within the next 6 months
    following baseline.
    Use of intravitreal or topical ocular corticosteroids administered for at least 30
    consecutive days within 3 months prior to screening.
    For fellow eye
    Retinal or choroidal neovascularization or macula edema of any cause
    Other protocol-defined inclusion/exclusion criteria may apply.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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