Phase 4 N=41 Randomized Single-blind Treatment

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

Wet Age-Related Macular Degeneration

Bottom Line

View on ClinicalTrials.gov: NCT02257632 ↗

Enrolled (actual)

Serious AEs

8.8%

Results posted

May 2019

Primary outcome: Primary: Standardized Area Under the Curve (AUC) for VEGF A Levels by SIMOA (Quanterix's Single Molecule Array) Method for the Comparative Phase — 18.78; 33.95 pg/mL — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ranibizumab 0.5 mg (Drug); Aflibercept 2 mg (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Mar 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Standardized Area Under the Curve (AUC) for VEGF A Levels by SIMOA (Quanterix's Single Molecule Array) Method for the Comparative Phase	18.78; 33.95	<0.0001 sig
SECONDARY Systemic VEGF-A Protein Levels From Study Week 12 to 24	17.93; 29.07	< 0.0001 sig
SECONDARY Systemic VEGF-A Levels From Study Week 12 to 24 (Change From Baseline)	-1.37; 23.73; -1.00; 21.93; -0.01; 19.26	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02257632). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.