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A Pharmacokinetic Study: Ranibizumab, Aflibercept and the Effect of Vitrectomy. (VITCLEAR)

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: NCT02174211
Recruitment Status : Completed
First Posted : June 25, 2014
Last Update Posted : April 30, 2021
Sponsor:
Collaborator:
King's College London
Information provided by (Responsible Party):
King's College Hospital NHS Trust

Study Description
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Brief Summary:
To study the effect of pars plana vitrectomy on the intravitreal pharmacokinetics of ranibizumab and to compare the half-life of ranibizumab and aflibercept.

Condition or disease Intervention/treatment Phase
Age Related Macular Degeneration Drug: Ranibizumab Drug: Aflibercept Not Applicable

Detailed Description:

This study is a prospective, pharmacokinetic study comparing ranibizumab clearance in two groups of patients; those with and without prior vitrectomy. Additionally it will compare ranibizumab clearance to aflibercept clearance as well as the effect on systemic circulating inflammatory and safety markers. Patients will already be receiving ranibizumab or aflibercept therapy - the injection is itself administered irrespective of their participation in this study and therefore this study will not alter medical management or the choice of therapy.

To estimate ranibizumab and aflibercept clearance, it is important to measure serum concentrations at several intervals within the first 24 hours. Participants will ideally have venous blood sampling at the following times after their ranibizumab or aflibercept injection:

  • 1 hour
  • 2 hours
  • 3 hours
  • 4 hours
  • 6 hours
  • 24 hours
  • 2 days
  • 4 days
  • 1 week*
  • 2 weeks
  • 4 weeks*
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pharmacokinetic Study: Ranibizumab, Aflibercept and the Effect of Vitrectomy.
Study Start Date : June 2014
Actual Primary Completion Date : November 2020
Actual Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm A: Ranibizumab (Lucentis)
Previous Vitrectomy
 Drug: Ranibizumab
Intravitreal injection of ranibizumab
Other Name: Lucentis
Active Comparator: Arm B: Ranibizumab (Lucentis)
Non-vitrectomised, PVD / no PVD
 Drug: Ranibizumab
Intravitreal injection of ranibizumab
Other Name: Lucentis
Active Comparator: Arm C: Aflibercept (Eylea)
Non-vitrectomised, PVD / no PVD
 Drug: Aflibercept
Intravitreal injection of aflibercept
Other Name: Eylea


Outcome Measures
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Primary Outcome Measures :
  1. Ranibizumab half-life [ Time Frame: 12 Months ]
    Vitrectomised and non-vitrectomised patients

  2. Aflibercept half-life [ Time Frame: 12 Months ]
    Non-vitrectomised patients only


Secondary Outcome Measures :
  1. Sub-group analysis of the effect of PVD on ranibizumab half-life [ Time Frame: 12 months ]
    Measurement of half-life (drug assay)

  2. The effect of ranibizumab and aflibercept concentrations on serum inflammatory and safety marker levels. [ Time Frame: 12 months ]
    Assay levels of cytokines and inflammatory/safety markers


Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Adults of either sex aged 55 years and older
  • Active neovascular AMD in the study eye
  • Intravitreal dose of 0.5 mg ranibizumab or 2 mg aflibercept required, as per current clinical guidelines
  • Venous access that is sufficient to allow easy blood sampling on a frequent basis
  • Able to give written consent
  • Willingness to comply with all study procedures

Exclusion criteria

  • Myopia greater than 8 dioptres in the study eye
  • Axial length of eye under 20mm or over 26mm
  • Aphakia in study eye
  • Pseudophakia with a defect in the posterior capsule
  • Glaucoma in study eye
  • Current renal dialysis
  • Presence of inflammatory eye conditions, such as uveitis, or systemic conditions likely to elevate CRP.
  • Intraocular surgery within 6 months of enrolment, except for routine phacoemulsification cataract surgery that may occur within 4 months of enrolment
  • Current treatment for wet age-related macular degeneration with an intravitreal agent other than ranibizumab or aflibercept in the study eye. Patients expected to change their anti-VEGF agent during the sampling period are also excluded.
  • Known significant allergy to ranibizumab or aflibercept
  • Participants who, in the opinion of the Investigator, would not be willing or able to comply with the study protocol or provide informed consent.
  • Patients with severe anaemia
  • Patients who have received anti-VEGF therapy in either eye within 8 weeks of enrolment, or who are likely to require anti-VEGF treatment in the fellow eye during the course of venous sampling. Note that the final venous sample at 4 weeks can be undertaken on the same day as an anti-VEGF injection, but must be taken prior to any injection.
  • Patients presently taking any topical (skin or eye), periocular, intraocular, local or systemic treatment with immunosuppressive or anti-inflammatory agents, such as steroids, steroid sparing agents, and NSAIDs. Patients who have received any of these agents within 2 months prior to enrolment are also excluded, as are those thought likely to receive these medications during the course of venous sampling.
Contacts and Locations
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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): NCT02174211


Locations
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United Kingdom
King's College Hospital NHS Foundation Trust
London, UK, United Kingdom, SE5 9RS
Sponsors and Collaborators
King's College Hospital NHS Trust
King's College London
Investigators
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Principal Investigator: Timothy L Jackson, PhD,FRCOphth King's College Hospital, London
More Information
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Responsible Party: King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT02174211    
Other Study ID Numbers: EudraCT Number: 2012-005500-18
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The Investigator(s) shall permit trial-related monitoring, audits, REC review, and regulatory inspections (where appropriate) by providing direct access to source data and other documents (i.e. patients' case sheets, blood test reports, X-ray reports, histology reports etc). Where necessary, inspection may also take place at the site's facilities.
Additional relevant MeSH terms:
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Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Ranibizumab
Aflibercept
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents