Age Related Macular DegenerationPhase 2/3NCT02296567
Comparison of Pharmacokinetics of and Effect on Systemic VEGF Levels in Age Related Macular Degeneration Patients
A Phase 2/3 study testing Ranibizumab, Bevacizumab and Aflibercept in people with Age Related Macular Degeneration, run by East Florida Eye Institute at 1 site in United States.
Trial summary
To demonstrate the effects of Lucentis (ranibizumab), Avastin ( bevacizumab), and Eylea ( aflibercept) on the levels of naturally occurring Vascular Endothelial Growth Factor (VEGF) in the systemic circulation of Age Related Macular Degeneration patients currently treated with these medications. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- Ranibizumab, Bevacizumab and Aflibercept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Jul 2016
- Phase
- Phase 2/3
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide written informed consent for participation in this study.
- Adults ≥ 50 years of age with exudative macular degeneration treated with Avastin, Lucentis, or Eylea in previously determined time intervals exclusive to a single anti-VEGF treatment type for not than three months.
- CONTROL GROUP: Age matched control group with no previously diagnosed exudative macular degeneration will also be enrolled.
- Provide signed informed consent.
Who cannot join
- Uncontrolled blood pressure (defined as systolic > 160mm Hg or Diastolic > 95mm Hg while patient is sitting)
- Uncontrolled diabetes mellitus defined by Hemoglobin A1c (HbA1C > 12% at screening)
- Concomitant ocular or systemic administration of drugs that may interfere with or potentiate the mechanism of action of anti-VEGF medications.
- Previous administration of systemic anti-angiogenic medications within 3 months
- Participation in a simultaneous medical investigation or trial.
- Treatment within 2 months with anti-VEGF agent in the fellow eye or anticipated need for further treatment during the study.
Show all 11Show fewer
- Patients with any cancer diagnosis in remission for less than five years with the exception that patients with skin cancers, basal cell or squamous cell, treated exclusively or topical treatment will be allowed.
- Female patients who have not reached menopause, defined as cessation of menses for a minimum of twelve months with no perimenopausal symptoms.
- Patients who have significant wound healing during the trial.
- Patients with a history of vitrectomy in the study eye.
- patients with uncontrolled psoriasis, rheumatoid arthritis, osteoarthritis.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
East Florida Eye Institute
Stuart, Florida, 34994
Ronald E. Frenkel, MD, 772-287-9000, info@efei.com
About this study
Official title: Comparison of Pharmacokinetics of and Effect on Systemic Vascular Endothelial Growth Factor (VEGF) Levels Over Time of Intravitreal Ranibizumab and Bevacizumab and Aflibercept in Age Related Macular Degeneration Patients
To demonstrate the effects of Lucentis (ranibizumab), Avastin ( bevacizumab), and Eylea ( aflibercept) on the levels of naturally occurring Vascular Endothelial Growth Factor (VEGF) in the systemic circulation of Age Related Macular Degeneration patients currently treated with these medications.
Read the detailed description
To determine plasma levels of VEGF and serum Pharmacokinetic (PK) levels after varying lengths of time following intravitreal injection with Avastin, Lucentis, or Eylea in exudative macular degeneration. Patients will be tested while following a normal course of treatment in our institute. All screenings and testing will be conducted in three study visits.
- Conditions
- Age Related Macular Degeneration
- Being tested
- Ranibizumab, Bevacizumab, Aflibercept, Control Group
- 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
Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care.
BevacizumabDrug
Also called Avastin
Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care.
AfliberceptDrug
Also called Eylea
Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care.
RanibizumabDrug
Also called Lucentis
Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care.
BevacizumabDrug
Also called Avastin
Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care
AfliberceptDrug
Also called Eylea
Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care
RanibizumabDrug
Also called Lucentis
Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care
BevacizumabDrug
Also called Avastin
Drug: Bevacizumab Subjects will receive intravitreal bevacizumab as part of their routine medical care
AfliberceptDrug
Also called Eylea
Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care
Control GroupOther
Control group Subjects will no previous anti-VEGF treatment
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Lucentis 4 weeks | Active comparator | Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy. Receives: Drug: Ranibizumab |
| Group 2 Avastin 4 weeks | Active comparator | Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy. Receives: Drug: Bevacizumab |
| Group 3 Eylea 4 weeks | Active comparator | Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy. Receives: Drug: Aflibercept |
| Group 4 Lucentis 6 weeks | Active comparator | Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy. Receives: Drug: Ranibizumab |
| Group 5 Avastin 6 weeks | Active comparator | Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy. Receives: Drug: Bevacizumab |
| Group 6 Eylea 6 weeks | Active comparator | Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy. Receives: Drug: Aflibercept |
| Group 7 Lucentis 8 weeks | Active comparator | Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy. Receives: Drug: Ranibizumab |
| Group 8 Avastin 8 weeks | Active comparator | Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy. Receives: Drug: Bevacizumab |
| Group 9 Eylea 8 weeks | Active comparator | Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy. Receives: Drug: Aflibercept |
| Group 10 Control Group no treatment | Active comparator | Blood samples will be collected from patients who are not receiving anti-VEGF treatment. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum and plasma levels of free Vascular Endothelial Growth Factor
Serum and plasma levels of free vascular endothelial growth factor will be measured up to 8 weeks following the standard of care treatment.
Measured: up to 8 weeks
Secondary outcomes (2)
Change in Serum drug levels in nanomoles (nM) units following treatment
Serum levels of Ranibizumab, Bevacizumab, or Aflibercept will be measured up to 8 weeks following the standard of care treatment.
Measured: 8 weeks
Amount of fluid (cubic mm) as measured by Ocular Coherence Tomography in the contralateral eye will be correlated with systemic Vascular Endothelial Growth Factor levels
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
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.
- 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 2/3
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Florida Eye Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Ronald E. Frenkel, MD, East Florida Eye Institute
- Investigators
- Ronald E Frenkel, MD, Principal investigator, East Florida Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296567
- Sponsor's protocol ID
- ML29189
- Status last verified
- Aug 2015
- First submitted
- 5 Nov 2014
- Last updated
- 11 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pharmacokinetics of and Effect on Systemic Vascular Endothelial Growth Factor (VEGF) Levels Over Time of Intravitreal Ranibizumab and Bevacizumab and Aflibercept in Age Related Macular Degeneration Patients
- ClinicalTrials.gov ID
- NCT02296567
- Acronym / sponsor ID
- ML29189
- Conditions
- Age Related Macular Degeneration
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- East Florida Eye InstituteUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Dec 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 20 Nov 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 demonstrate the effects of Lucentis (ranibizumab), Avastin ( bevacizumab), and Eylea ( aflibercept) on the levels of naturally occurring Vascular Endothelial Growth Factor (VEGF) in the systemic circulation of Age Related Macular Degeneration patients currently treated with these medications.
Detailed description
To determine plasma levels of VEGF and serum Pharmacokinetic (PK) levels after varying lengths of time following intravitreal injection with Avastin, Lucentis, or Eylea in exudative macular degeneration. Patients will be tested while following a normal course of treatment in our institute. All screenings and testing will be conducted in three study visits.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Group 1 Lucentis 4 weeks | Active comparator | Drug: RanibizumabBlood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy. |
| Group 2 Avastin 4 weeks | Active comparator | Drug: BevacizumabBlood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy. |
| Group 3 Eylea 4 weeks | Active comparator | Drug: AfliberceptBlood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy. |
| Group 4 Lucentis 6 weeks | Active comparator | Drug: RanibizumabBlood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy. |
| Group 5 Avastin 6 weeks | Active comparator | Drug: BevacizumabBlood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy. |
| Group 6 Eylea 6 weeks | Active comparator | Drug: AfliberceptBlood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy. |
| Group 7 Lucentis 8 weeks | Active comparator | Drug: RanibizumabBlood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy. |
| Group 8 Avastin 8 weeks | Active comparator | Drug: BevacizumabBlood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy. |
| Group 9 Eylea 8 weeks | Active comparator | Drug: AfliberceptBlood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy. |
| Group 10 Control Group no treatment | Active comparator | Other: Control GroupBlood samples will be collected from patients who are not receiving anti-VEGF treatment. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to provide written informed consent for participation in this study.
- Adults ≥ 50 years of age with exudative macular degeneration treated with Avastin, Lucentis, or Eylea in previously determined time intervals exclusive to a single anti-VEGF treatment type for not than three months.
- CONTROL GROUP: Age matched control group with no previously diagnosed exudative macular degeneration will also be enrolled.
- Provide signed informed consent.
Key exclusion criteria (11 listed)
- Uncontrolled blood pressure (defined as systolic > 160mm Hg or Diastolic > 95mm Hg while patient is sitting)
- Uncontrolled diabetes mellitus defined by Hemoglobin A1c (HbA1C > 12% at screening)
- Concomitant ocular or systemic administration of drugs that may interfere with or potentiate the mechanism of action of anti-VEGF medications.
- Previous administration of systemic anti-angiogenic medications within 3 months
- Participation in a simultaneous medical investigation or trial.
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: LucentisDrug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care. | Drug | Group 1 Lucentis 4 weeks |
| BevacizumabAlso: AvastinDrug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care. | Drug | Group 2 Avastin 4 weeks |
| AfliberceptAlso: EyleaDrug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care. | Drug | Group 3 Eylea 4 weeks |
| RanibizumabAlso: LucentisDrug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care. | Drug | Group 4 Lucentis 6 weeks |
| BevacizumabAlso: AvastinDrug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care | Drug | Group 5 Avastin 6 weeks |
| AfliberceptAlso: EyleaDrug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care | Drug | Group 6 Eylea 6 weeks |
| RanibizumabAlso: LucentisDrug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care | Drug | Group 7 Lucentis 8 weeks |
| BevacizumabAlso: AvastinDrug: Bevacizumab Subjects will receive intravitreal bevacizumab as part of their routine medical care | Drug | Group 8 Avastin 8 weeks |
| AfliberceptAlso: EyleaDrug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care | Drug | Group 9 Eylea 8 weeks |
| Control GroupControl group Subjects will no previous anti-VEGF treatment | Other | Group 10 Control Group no treatment |
Primary outcome
Change in serum and plasma levels of free Vascular Endothelial Growth Factor
Time frame: up to 8 weeks
Serum and plasma levels of free vascular endothelial growth factor will be measured up to 8 weeks following the standard of care treatment.
2 secondary outcomes
Change in Serum drug levels in nanomoles (nM) units following treatment
Time frame: 8 weeks
Amount of fluid (cubic mm) as measured by Ocular Coherence Tomography in the contralateral eye will be correlated with systemic Vascular Endothelial Growth Factor levels
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2015.
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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.
Ronald E Frenkel, MD principal investigator
East Florida Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ranibizumab, Bevacizumab and Aflibercept in people with Age Related Macular Degeneration, run by East Florida Eye Institute at 1 site in United States.
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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 11 Aug 2015. 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 States. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronald E. Frenkel, MD (772.287.9000, info@efei.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum and plasma levels of free Vascular Endothelial Growth Factor (time frame: up to 8 weeks). 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 11 Aug 2015.