A Randomized, Single-blinded, Multicenter, Phase IV Study to Compare Systemic VEGF Protein Dynamics Following Monthly Intravitreal Injections of 0.5 mg Ranibizumab Versus 2 mg Aflibercept Until Study Week 12 in Patients With Neovascular (Wet) Age-related Macular Degeneration
Overview
- Phase
- Phase 4
- Intervention
- Ranibizumab 0.5 mg
- Conditions
- Wet Age-Related Macular Degeneration
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Standardized Area Under the Curve (AUC) for VEGF A Levels by SIMOA (Quanterix's Single Molecule Array) Method for the Comparative Phase
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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 Degeneration (wAMD) patients in a detailed time course.
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 (± 1 day to allow for flexibility in scheduling) and as of day 15 through to day 169 at biweekly visits.
Investigators
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
Arms & Interventions
Group 1
6 monthly intravitreal injections of 0.5 mg ranibizumab
Intervention: Ranibizumab 0.5 mg
Group 2
3 monthly intravitreal injections of 2 mg aflibercept followed by 3 monthly intravitreal injections of 0.5 mg ranibizumab
Intervention: Ranibizumab 0.5 mg
Group 2
3 monthly intravitreal injections of 2 mg aflibercept followed by 3 monthly intravitreal injections of 0.5 mg ranibizumab
Intervention: Aflibercept 2 mg
Outcomes
Primary Outcomes
Standardized Area Under the Curve (AUC) for VEGF A Levels by SIMOA (Quanterix's Single Molecule Array) Method for the Comparative Phase
Time Frame: Baseline up to Week 12 visit (Days 1, 2, 8, 15, 29, 43, 57, 71, 85)
The AUC was calculated using the trapezoidal rule, where all available measurement between Day 1 and Week 12 were used. The AUC was standardized by dividing the calculated value by the number of days from first to last measurement.
Secondary Outcomes
- Systemic VEGF-A Protein Levels From Study Week 12 to 24(From study week 12 to 24 (Days 85, 99, 113, 127, 141, 155, 169))
- Systemic VEGF-A Levels From Study Week 12 to 24 (Change From Baseline)(From study week 12 to 24)