Overview

Systemic Vascular Endothelial Growth Factor (VEGF) Protein Dynamics Following Intravitreal Injections of Ranibizumab Versus Aflibercept in Patients With Neovascular Age-related Macular Degeneration

Status:
Completed
Trial end date:
2017-06-08
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Aflibercept
Ranibizumab
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.