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)

Phase 4CompletedNCT01988662

Novartis Pharmaceuticals205 enrolled

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 .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

205

Conditions

Neovacular Age-related Macular Degeneration

Interventions

Neovascular Age-related Macular DegenerationPROCEDURE

Blood measurement

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (24)

Novartis Investigative Site

Beersheba, Israel

Outcomes

Primary Outcomes

Percent Change From Baseline at Month 3 in Plasma VEGF Following Intravitreal (IVT) Injection of Anti-VEGF Agent

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.

Time frame: Change from baseline at Month 3

Secondary Outcomes

Percent Change From Baseline in Plasma VEGF Level Overtime

Plasma VEGF measurement performed at all visits and compared to baseline level

Time frame: Change from baseline up to month 3

Correlation Between Percent Change From Baseline Plasma VEGF Level and the Serum Anti-VEGF Agent Overtime

VEGF level and anti-VEGF concentration measured in the blood at each single visit, including pre- and post-dose measurement at the dosing visits.

Time frame: pre-dose to post-dose at Baseline, week 1, week 2, month 1, month 2, and month 3

Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye Over Time

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.

Time frame: Baseline, month 1, month 2, month 3

Mean Change From Baseline in Central Retinal Thickness (CRT) of the Study Eye Over Time

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.

Time frame: Baseline, month 1, month 2, month 3

Data from ClinicalTrials.gov

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