Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01988662
Recruitment Status : Completed
First Posted : November 20, 2013
Results First Posted : February 28, 2017
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( 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 .


Condition or disease Intervention/treatment Phase
Neovacular Age-related Macular Degeneration Procedure: Neovascular Age-related Macular Degeneration Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : April 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
Procedure: Neovascular Age-related Macular Degeneration
Blood measurement
Other Name: Lucentis, Eylea

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).
Procedure: Neovascular Age-related Macular Degeneration
Blood measurement
Other Name: Lucentis, Eylea




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.


  5. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01988662


Locations
Layout table for location information
Israel
Novartis Investigative Site
Be'er Sheva, Israel, 84101
Novartis Investigative Site
Haifa, Israel, 3436212
Novartis Investigative Site
Haifa, Israel, 3525408
Novartis Investigative Site
Kfar-Saba, Israel, 4428164
Novartis Investigative Site
Petach Tikva, Israel, 49100
Novartis Investigative Site
Rehovot, Israel, 7610001
Novartis Investigative Site
Tel Aviv, Israel, 6423906
Korea, Republic of
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 03722
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 05505
Novartis Investigative Site
Daegu, Korea, Republic of, 705-703
Novartis Investigative Site
Seoul, Korea, Republic of, 06273
Novartis Investigative Site
Seoul, Korea, Republic of, 150-950
Malaysia
Novartis Investigative Site
Petaling Jaya, Selangor Darul Ehsan, Malaysia, 46200
Novartis Investigative Site
Kuala Lumpur, Malaysia, 59200
Philippines
Novartis Investigative Site
Makati City, Philippines, 1209
Novartis Investigative Site
Pasig City, Philippines, 1605
Novartis Investigative Site
Quezon City, Philippines, 1102
Singapore
Novartis Investigative Site
Singapore, Singapore, 117549
Novartis Investigative Site
Singapore, Singapore, 574623
Taiwan
Novartis Investigative Site
Lin-Kou, Taiwan, 33305
Novartis Investigative Site
Taipei, Taiwan, 10002
Thailand
Novartis Investigative Site
Bangkok, Bangkoknoi, Thailand, 10700
Novartis Investigative Site
Bangkok, Thailand, 10330
Novartis Investigative Site
Bangkok, Thailand, 10400
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01988662    
Other Study ID Numbers: CRFB002A-MAX-IL-01
2013-003482-34 ( EudraCT Number )
First Posted: November 20, 2013    Key Record Dates
Results First Posted: February 28, 2017
Last Update Posted: May 3, 2017
Last Verified: March 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
nAMD, VEGF, VEGF agent, BCVA, CRT, Ranibizumab, Lucentis, Aflibercept, Eylea
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents