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

NCT02174211 | Completed

• 1 other identifier: EudraCT Number: 2012-005500-18
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Age Related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

• Ranibizumab half-life

  Vitrectomised and non-vitrectomised patients

  12 Months

• Aflibercept half-life

  Non-vitrectomised patients only

  12 Months

Secondary Outcomes (2)

• Sub-group analysis of the effect of PVD on ranibizumab half-life

  12 months

• The effect of ranibizumab and aflibercept concentrations on serum inflammatory and safety marker levels.

  12 months

Study Arms (3)

Arm A: Ranibizumab (Lucentis)

ACTIVE COMPARATOR

Previous Vitrectomy

Drug: Ranibizumab

Arm B: Ranibizumab (Lucentis)

ACTIVE COMPARATOR

Non-vitrectomised, PVD / no PVD

Drug: Ranibizumab

Arm C: Aflibercept (Eylea)

ACTIVE COMPARATOR

Non-vitrectomised, PVD / no PVD

Drug: Aflibercept

Interventions

Ranibizumab DRUG

Intravitreal injection of ranibizumab

Also known as: Lucentis

Arm A: Ranibizumab (Lucentis); Arm B: Ranibizumab (Lucentis)

Aflibercept DRUG

Intravitreal injection of aflibercept

Also known as: Eylea

Arm C: Aflibercept (Eylea)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• King's College London: collaborator

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, UK, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab; aflibercept

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Timothy L Jackson, PhD,FRCOphth

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 25, 2014
• Study Start: June 1, 2014
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 30, 2021

Record last verified: 2021-04

Locations

GB (1)