UNcovering the Difference Between Ranibizumab and Aflibercept, Focusing on Systemic Anti-vascular Endothelial Growth Factor (VEGF) Effects in Patients With neovascuLar Age-related Macular Degeneration (AMD)

Overview

This study assessed systemic vascular endothelial growth factor (VEGF) level in patients with neovascular Age-related Macular Degeneration following treatment with Ranibizumab or Aflibercept.

Free plasma VEGF-A level was measured in this study .

Full Title of Study: “A 3 Months, patient-and Rater Blinded, Randomized, Prospective Study Comparing Systemic Anti-VEGF Effects Between Ranibizumab and Aflibercept in Treatment na├»ve Neovascular Age-related Macular Degeneration (nAMD) Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: September 2015

Interventions

  • Procedure: Neovascular Age-related Macular Degeneration
    • Blood measurement

Arms, Groups and Cohorts

  • Experimental: Ranibizumab
    • 104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection adminstered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
  • Active Comparator: Aflibercept
    • 101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection admistered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).

Clinical Trial Outcome Measures

Primary Measures

  • Percent Change From Baseline at Month 3 in Plasma VEGF Following Intravitreal (IVT) Injection of Anti-VEGF Agent
    • Time Frame: Change from baseline at Month 3
    • Percent change in blood VEGF level is calculated as the difference in blood VEGF level measured after 3 month of anti-VEGF agent IVT treatment (Ranibizumab or Aflibercept) when compared to baseline blood VEGF level.

Secondary Measures

  • Percent Change From Baseline in Plasma VEGF Level Overtime
    • Time Frame: Change from baseline up to month 3
    • Plasma VEGF measurement performed at all visits and compared to baseline level
  • Correlation Between Percent Change From Baseline Plasma VEGF Level and the Serum Anti-VEGF Agent Overtime
    • Time Frame: pre-dose to post-dose at Baseline, week 1, week 2, month 1, month 2, and month 3
    • VEGF level and anti-VEGF concentration measured in the blood at each single visit, including pre- and post-dose measurement at the dosing visits.
  • Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye Over Time
    • Time Frame: Baseline, month 1, month 2, month 3
    • BCVA score is assessed on study eye based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts at a testing distance of 4 meters. An increase in score indicates an improvement in acuity. Change from baseline calculated as observed post-baseline value – baseline value.
  • Mean Change From Baseline in Central Retinal Thickness (CRT) of the Study Eye Over Time
    • Time Frame: Baseline, month 1, month 2, month 3
    • CRT in micrometers assessed by Optical Tomography (OCT) at each single study visit. A reduction is thickness indicates an improvement is the lesion area. Change from baseline calculated as observed post-baseline – baseline value.
  • Number of Patients With Ocular and Systemic Adverse Events
    • Time Frame: Day 1 to day 85
    • The incidence of reported treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAE).

Participating in This Clinical Trial

Key Inclusion Criteria

  • Newly diagnosed Age-related Macular Degeneration (AMD)
  • No previous treatment received for diagnosed AMD
  • Visual Acuity 6/7.5 to 6/96

Key Exclusion Criteria:

  • standard exclusion criteria for anti-VEGF treatment
  • Visual Acuity <6/96
  • nAMD in both eyes, or any condition in other eye which may have required anti- VEGF treatment during study period
  • other disease in candidate eye which could have compromised visual acuity or required medical/surgical intervention during study period
  • participation to other clinical study with 'not approved' treatment within a year prior to UNRAVEL study participation.

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals

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