Status:
COMPLETED
Systemic Vascular Endothelial Growth Factor (VEGF) Protein Dynamics Following Intravitreal Injections of Ranibizumab Versus Aflibercept in Patients With Neovascular Age-related Macular Degeneration
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Wet Age-Related Macular Degeneration
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 Dege...
Detailed Description
A planned study visit schedule was established at the time of baseline visit (day 1) for all patients. Study assessments for patients were performed at screening visit, baseline (day 1), day 2, day 8 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 8 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2017
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT02257632
Start Date
April 8 2015
End Date
June 8 2017
Last Update
May 7 2019
Active Locations (6)
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1
Novartis Investigative Site
Cologne, Germany, 50924
2
Novartis Investigative Site
Marburg, Germany, 35039
3
Novartis Investigative Site
München, Germany, 80336
4
Novartis Investigative Site
München, Germany, 81675