Age Related Macular DegenerationVITCLEARNCT02174211
A Pharmacokinetic Study: Ranibizumab, Aflibercept and the Effect of Vitrectomy.
A study testing Ranibizumab and Aflibercept in people with Age Related Macular Degeneration, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- Ranibizumab and Aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2014to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College Hospital NHS Foundation Trust
London, UK, SE5 9RS
About this study
To study the effect of pars plana vitrectomy on the intravitreal pharmacokinetics of ranibizumab and to compare the half-life of ranibizumab and aflibercept.
Read the 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*
- Conditions
- Age Related Macular Degeneration
- Being tested
- Ranibizumab, Aflibercept
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
Intravitreal injection of ranibizumab
AfliberceptDrug
Also called Eylea
Intravitreal injection of aflibercept
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Ranibizumab (Lucentis) | Active comparator | Previous Vitrectomy Receives: Drug: Ranibizumab |
| Arm B: Ranibizumab (Lucentis) | Active comparator | Non-vitrectomised, PVD / no PVD Receives: Drug: Ranibizumab |
| Arm C: Aflibercept (Eylea) | Active comparator | Non-vitrectomised, PVD / no PVD Receives: Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ranibizumab half-life
Vitrectomised and non-vitrectomised patients
Measured: 12 Months
Aflibercept half-life
Non-vitrectomised patients only
Measured: 12 Months
Secondary outcomes (2)
Sub-group analysis of the effect of PVD on ranibizumab half-life
Measurement of half-life (drug assay)
Measured: 12 months
The effect of ranibizumab and aflibercept concentrations on serum inflammatory and safety marker levels.
Assay levels of cytokines and inflammatory/safety markers
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionNov 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Timothy L Jackson, PhD,FRCOphth, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174211
- Sponsor's protocol ID
- EudraCT Number: 2012-005500-18
- Acronym
- VITCLEAR
- Status last verified
- Apr 2021
- First submitted
- 24 Jun 2014
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Study: Ranibizumab, Aflibercept and the Effect of Vitrectomy.
- ClinicalTrials.gov ID
- NCT02174211
- Acronym / sponsor ID
- VITCLEAR / EudraCT Number: 2012-005500-18
- Conditions
- Age Related Macular Degeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- Jun 2014
- Primary completion
- Nov 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 25 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the effect of pars plana vitrectomy on the intravitreal pharmacokinetics of ranibizumab and to compare the half-life of ranibizumab and aflibercept.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Ranibizumab (Lucentis) | Active comparator | Drug: RanibizumabPrevious Vitrectomy |
| Arm B: Ranibizumab (Lucentis) | Active comparator | Drug: RanibizumabNon-vitrectomised, PVD / no PVD |
| Arm C: Aflibercept (Eylea) | Active comparator | Drug: AfliberceptNon-vitrectomised, PVD / no PVD |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RanibizumabAlso: LucentisIntravitreal injection of ranibizumab | Drug | Arm A: Ranibizumab (Lucentis), Arm B: Ranibizumab (Lucentis) |
| AfliberceptAlso: EyleaIntravitreal injection of aflibercept | Drug | Arm C: Aflibercept (Eylea) |
Primary outcome
Ranibizumab half-life
Time frame: 12 Months
Vitrectomised and non-vitrectomised patients
Aflibercept half-life
Time frame: 12 Months
Non-vitrectomised patients only
2 secondary outcomes
Sub-group analysis of the effect of PVD on ranibizumab half-life
Time frame: 12 months
The effect of ranibizumab and aflibercept concentrations on serum inflammatory and safety marker levels.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy L Jackson, PhD,FRCOphth principal investigator
King's College Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ranibizumab and Aflibercept in people with Age Related Macular Degeneration, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ranibizumab half-life (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.