Systemic Vascular Endothelial Growth Factor (VEGF) Protein Dynamics Following Intravitreal Injections of Ranibizumab Versus Aflibercept in Patients With Neovascular Age-related Macular Degeneration
Condition: Wet Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Ranibizumab 0.5 mg; Aflibercept 2 mg
Intervention description: Administered as an intravitreal injection; Administered as an intravitreal injection
Intervention MeSH terms: Ranibizumab; Aflibercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study was to compare the effect of intravitreal injections of ranibizumab
      and aflibercept on systemic VEGF protein levels in treatment naïve wet neovascular
      Age-related Macular Degeneration (wAMD) patients in a detailed time course.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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
             baseline.

          -  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.