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 4

Completed

• Conditions: Neovacular Age-related Macular Degeneration
• Interventions: Procedure: Neovascular Age-related Macular Degeneration

• Registration Number: NCT01988662
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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 .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-14
• Study First Submitted QC: 2013-11-14
• Study First Posted: 2013-11-20
• Study Start: 2014-04
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Results First Submitted: 2016-09-01
• Results First Submitted QC: 2017-01-09
• Results First Posted: 2017-02-28
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-30
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ranibizumab	Neovascular Age-related Macular Degeneration	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).
Aflibercept	Neovascular Age-related Macular Degeneration	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).

Primary Outcome Measures

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

Name	Time	Method
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye Over Time	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	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.
Percent Change From Baseline in Plasma VEGF Level Overtime	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	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.
Number of Patients With Ocular and Systemic Adverse Events	Day 1 to day 85	The incidence of reported treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAE).

Trial Locations

Locations (1)

Novartis Investigative Site; 🇹🇭 Bangkok, Thailand