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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) (UNRAVEL)

Primary Purpose

Neovacular Age-related Macular Degeneration

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Neovascular Age-related Macular Degeneration
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovacular Age-related Macular Degeneration focused on measuring nAMD, VEGF, VEGF agent, BCVA, CRT, Ranibizumab, Lucentis, Aflibercept, Eylea

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ranibizumab

Aflibercept

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percent Change From Baseline in Plasma VEGF Level Overtime
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
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
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
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
The incidence of reported treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAE).

Full Information

First Posted
November 14, 2013
Last Updated
March 30, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01988662
Brief Title
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)
Acronym
UNRAVEL
Official Title
A 3 Months, patient-and Rater Blinded, Randomized, Prospective Study Comparing Systemic Anti-VEGF Effects Between Ranibizumab and Aflibercept in Treatment naïve Neovascular Age-related Macular Degeneration (nAMD) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovacular Age-related Macular Degeneration
Keywords
nAMD, VEGF, VEGF agent, BCVA, CRT, Ranibizumab, Lucentis, Aflibercept, Eylea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
205 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ranibizumab
Arm Type
Experimental
Arm Description
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).
Arm Title
Aflibercept
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Neovascular Age-related Macular Degeneration
Other Intervention Name(s)
Lucentis, Eylea
Intervention Description
Blood measurement
Primary Outcome Measure Information:
Title
Percent Change From Baseline at Month 3 in Plasma VEGF Following Intravitreal (IVT) Injection of Anti-VEGF Agent
Description
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 Outcome Measure Information:
Title
Percent Change From Baseline in Plasma VEGF Level Overtime
Description
Plasma VEGF measurement performed at all visits and compared to baseline level
Time Frame
Change from baseline up to month 3
Title
Correlation Between Percent Change From Baseline Plasma VEGF Level and the Serum Anti-VEGF Agent Overtime
Description
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
Title
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye Over Time
Description
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
Title
Mean Change From Baseline in Central Retinal Thickness (CRT) of the Study Eye Over Time
Description
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
Title
Number of Patients With Ocular and Systemic Adverse Events
Description
The incidence of reported treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAE).
Time Frame
Day 1 to day 85

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Be'er Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Novartis Investigative Site
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Novartis Investigative Site
City
Haifa
ZIP/Postal Code
3525408
Country
Israel
Facility Name
Novartis Investigative Site
City
Kfar-Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Novartis Investigative Site
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Novartis Investigative Site
City
Rehovot
ZIP/Postal Code
7610001
Country
Israel
Facility Name
Novartis Investigative Site
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Daegu
ZIP/Postal Code
705-703
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
150-950
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Petaling Jaya
State/Province
Selangor Darul Ehsan
ZIP/Postal Code
46200
Country
Malaysia
Facility Name
Novartis Investigative Site
City
Kuala Lumpur
ZIP/Postal Code
59200
Country
Malaysia
Facility Name
Novartis Investigative Site
City
Makati City
ZIP/Postal Code
1209
Country
Philippines
Facility Name
Novartis Investigative Site
City
Pasig City
ZIP/Postal Code
1605
Country
Philippines
Facility Name
Novartis Investigative Site
City
Quezon City
ZIP/Postal Code
1102
Country
Philippines
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
117549
Country
Singapore
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
574623
Country
Singapore
Facility Name
Novartis Investigative Site
City
Lin-Kou
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Bangkok
State/Province
Bangkoknoi
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Novartis Investigative Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Novartis Investigative Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

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)

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