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Completed

NCT Number: NCT01988662

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)

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 .

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Key information

Conditions

Neovacular Age-related Macular Degeneration Creatine deficiency, X-linked

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Beersheba, Israel

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neovascular Age-related Macular Degeneration

Procedure

Blood measurement

Other names: Lucentis, Eylea

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: UNRAVEL

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 20, 2013
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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