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

NCT02257632 | Completed Phase 4 Results

• 1 other identifier: CRFB002ADE27
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 6

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.

Conditions

Wet Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Standardized Area Under the Curve (AUC) for VEGF A Levels by SIMOA (Quanterix's Single Molecule Array) Method for the Comparative Phase

  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.

  Baseline up to Week 12 visit (Days 1, 2, 8, 15, 29, 43, 57, 71, 85)

Secondary Outcomes (2)

• 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

Study Arms (2)

Group 1

EXPERIMENTAL

6 monthly intravitreal injections of 0.5 mg ranibizumab

Drug: Ranibizumab 0.5 mg

Group 2

EXPERIMENTAL

3 monthly intravitreal injections of 2 mg aflibercept followed by 3 monthly intravitreal injections of 0.5 mg ranibizumab

Drug: Ranibizumab 0.5 mg; Drug: Aflibercept 2 mg

Interventions

Ranibizumab 0.5 mg DRUG

Administered as an intravitreal injection

Also known as: Lucentis

Group 1; Group 2

Aflibercept 2 mg DRUG

Administered as an intravitreal injection

Also known as: Eylea

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (6)

Novartis Investigative Site

Cologne, 50924, Germany

Location

Novartis Investigative Site

Marburg, 35039, Germany

Location

Novartis Investigative Site

München, 80336, Germany

Location

Novartis Investigative Site

München, 81675, Germany

Location

Novartis Investigative Site

Osnabrück, 49076, Germany

Location

Novartis Investigative Site

Regensburg, 93042, Germany

Location

MeSH Terms

Interventions

Ranibizumab; aflibercept

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 6, 2014
• Study Start: April 8, 2015
• Primary Completion: March 20, 2017
• Study Completion: June 8, 2017
• Last Updated: May 7, 2019
• Results First Posted: May 7, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6)