Age-related Macular DegenerationPhase 1/2NCT02118831
Systemic Pharmacokinetics Following Intravitreal Injections of Anti-VEGF
A Phase 1/2 study testing Blood Sample Collection, Aflibercept and Bevacizumab in people with Age-related Macular Degeneration and Diabetic Macular Edema, run by California Retina Consultants.
Trial summary
Comparable data for bevacizumab and aflibercept are lacking, as are studies comparing the systemic levels of ranibizumab, bevacizumab, and aflibercept and their relative effects on circulating vascular endothelial growth factor. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Age-related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion
- What is being tested?
- Blood Sample Collection, Aflibercept and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Apr 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ability to provide written informed consent for participation in this study
- Subjects with a diagnosis of neovascular age-related macular degeneration, diabetic macular edema, or retinal vein occlusion who are either treatment naïve or more than 4 months out from a prior intravitreal anti-vascular endothelial growth factor injection
Who cannot join
- Subjects unwilling to receive 3 monthly injections of anti-vascular endothelial growth factor as initial therapy
- Subjects who may need or have received systemic anti-vascular endothelial growth factor for oncology in the past year
- Subjects with history of another ocular disease other than neovascular age-related macular degeneration, diabetic macular edema, or retinal vein occlusion
- Subjects with history of vitrectomy
About this study
Official title: Systemic Pharmacokinetics Following Intravitreal Injections of Ranibizumab, Bevacizumab or Aflibercept in Patients With Neovascular Age-related Macular Degeneration
Comparable data for bevacizumab and aflibercept are lacking, as are studies comparing the systemic levels of ranibizumab, bevacizumab, and aflibercept and their relative effects on circulating vascular endothelial growth factor. In the present prospective study, the investigators evaluated serum drug levels and plasma free vascular endothelial growth factor (VEGF) levels in patients with neovascular age-related macular degeneration following intravitreal injections of ranibizumab, bevacizumab and aflibercept.
- Being tested
- Blood Sample Collection, Aflibercept, Bevacizumab, Ranibizumab
- Keywords
- macular degeneration, diabetic macular edema, vein occlusion, vascular endothelial growth factor
- Medical subject headings
- Macular Degeneration, Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Sample CollectionBiological
Subjects will have their blood drawn for analysis following their first and third injections of anti-VEGF.
AfliberceptDrug
Also called Eylea
an intravitreal injection of Aflibercept administered three times on a monthly basis.
BevacizumabDrug
Also called Avastin
an intravitreal injection of Bevacizumab administered three times on a monthly basis.
RanibizumabDrug
Also called Lucentis
an intravitreal injection of Ranibizumab administered three times on a monthly basis.
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept Blood Sample Collection | Active comparator | Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy. Receives: Biological: Blood Sample Collection; Drug: Aflibercept |
| Bevacizumab Blood Sample Collection | Active comparator | Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy. Receives: Biological: Blood Sample Collection; Drug: Bevacizumab |
| Ranibizumab Blood Sample Collection | Active comparator | Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy. Receives: Biological: Blood Sample Collection; Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Pharmacokinetics Following Treatment From 1st and 3rd Doses
Maximum serum levels of ranibizumab, bevacizumab or aflibercept will be measured after the first and third injections, up to 28 days following each treatment.
Measured: Up to 4 months
Secondary outcomes (1)
Change in Minimum Serum Levels of Free Vascular Endothelial Growth Factor From Baseline to Month 4 (One Month After Last Treatment)
Minimum serum levels of free vascular endothelial growth factor will be measured at baseline and at 4 months following treatment (one month after last treatment).
Measured: baseline and month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startMar 2012
- Primary completionFeb 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-related Macular DegenerationStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Retina Consultants
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert L Avery, MD, Principal investigator, California Retina ConsultantsMelvin D Rabena, BS, Study director, California Retina Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118831
- Sponsor's protocol ID
- ML28032
- Status last verified
- Apr 2016
- First submitted
- 15 Apr 2014
- Last updated
- 19 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Avery RL, Castellarin AA, Steinle NC, Dhoot DS, Pieramici DJ, See R, Couvillion S, Nasir MA, Rabena MD, Le K, Maia M, Visich JE. Systemic pharmacokinetics following intravitreal injections of ranibizumab, bevacizumab or aflibercept in patients with neovascular AMD. Br J Ophthalmol. 2014 Dec;98(12):1636-41. doi: 10.1136/bjophthalmol-2014-305252. Epub 2014 Jul 7.
PubMed 25001321
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Pharmacokinetics Following Intravitreal Injections of Ranibizumab, Bevacizumab or Aflibercept in Patients With Neovascular Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02118831
- Acronym / sponsor ID
- ML28032
- Keywords
- macular degeneration, diabetic macular edema, vein occlusion, vascular endothelial growth factor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- California Retina ConsultantsUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Posted 19 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparable data for bevacizumab and aflibercept are lacking, as are studies comparing the systemic levels of ranibizumab, bevacizumab, and aflibercept and their relative effects on circulating vascular endothelial growth factor. In the present prospective study, the investigators evaluated serum drug levels and plasma free vascular endothelial growth factor (VEGF) levels in patients with neovascular age-related macular degeneration following intravitreal injections of ranibizumab, bevacizumab and aflibercept.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aflibercept Blood Sample Collection | Active comparator | Biological: Blood Sample Collection, Drug: AfliberceptBlood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy. |
| Bevacizumab Blood Sample Collection | Active comparator | Biological: Blood Sample Collection, Drug: BevacizumabBlood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy. |
| Ranibizumab Blood Sample Collection | Active comparator | Biological: Blood Sample Collection, Drug: RanibizumabBlood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Ability to provide written informed consent for participation in this study
- Subjects with a diagnosis of neovascular age-related macular degeneration, diabetic macular edema, or retinal vein occlusion who are either treatment naïve or more than 4 months out from a prior intravitreal anti-vascular endothelial growth factor injection
Key exclusion criteria (4 listed)
- Subjects unwilling to receive 3 monthly injections of anti-vascular endothelial growth factor as initial therapy
- Subjects who may need or have received systemic anti-vascular endothelial growth factor for oncology in the past year
- Subjects with history of another ocular disease other than neovascular age-related macular degeneration, diabetic macular edema, or retinal vein occlusion
- Subjects with history of vitrectomy
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 |
|---|---|---|
| Blood Sample CollectionSubjects will have their blood drawn for analysis following their first and third injections of anti-VEGF. | Biological | Aflibercept Blood Sample Collection, Bevacizumab Blood Sample Collection, Ranibizumab Blood Sample Collection |
| AfliberceptAlso: Eyleaan intravitreal injection of Aflibercept administered three times on a monthly basis. | Drug | Aflibercept Blood Sample Collection |
| BevacizumabAlso: Avastinan intravitreal injection of Bevacizumab administered three times on a monthly basis. | Drug | Bevacizumab Blood Sample Collection |
| RanibizumabAlso: Lucentisan intravitreal injection of Ranibizumab administered three times on a monthly basis. | Drug | Ranibizumab Blood Sample Collection |
Primary outcome
Serum Pharmacokinetics Following Treatment From 1st and 3rd Doses
Time frame: Up to 4 months
Maximum serum levels of ranibizumab, bevacizumab or aflibercept will be measured after the first and third injections, up to 28 days following each treatment.
1 secondary outcome
Change in Minimum Serum Levels of Free Vascular Endothelial Growth Factor From Baseline to Month 4 (One Month After Last Treatment)
Time frame: baseline and month 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25001321Avery RL, Castellarin AA, Steinle NC, Dhoot DS, Pieramici DJ, See R, Couvillion S, Nasir MA, Rabena MD, Le K, Maia M, Visich JE. Systemic pharmacokinetics following intravitreal injections of ranibizumab, bevacizumab or aflibercept in patients with neovascular AMD. Br J Ophthalmol. 2014 Dec;98(12):1636-41. doi: 10.1136/bjophthalmol-2014-305252. Epub 2014 Jul 7.
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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.
Robert L Avery, MD principal investigator
California Retina Consultants
Melvin D Rabena, BS study director
California Retina Consultants
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Blood Sample Collection, Aflibercept and Bevacizumab in people with Age-related Macular Degeneration and Diabetic Macular Edema, run by California Retina Consultants.
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 2 inclusion and 4 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 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Serum Pharmacokinetics Following Treatment From 1st and 3rd Doses (time frame: Up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02118831, which also lists 1 linked publication.
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 19 May 2016.