Exudative Age-related Macular DegenerationPhase 4Eylea-2014NCT02125864
Plasma Levels of Vascular Endothelial Growth Factor Before and After Intravitreal Injection of Aflibercept
A Phase 4 study testing intravitreal injection in people with Exudative Age-related Macular Degeneration, run by Oslo University Hospital.
Trial summary
The purpose of this study is to examine the plasma concentration of vascular endothelial growth factor (VEGF) after standard treatment with one of the newest growth factor inhibitors, aflibercept (Eylea). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Exudative Age-related Macular Degeneration
- What is being tested?
- intravitreal injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Nov 2014
- Phase
- Phase 4
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women with exudative AMD
- Central Retinal Thickness ≥ 250 microns
- Best corrected visual acuity 20/25-20/320
- Age ≥ 60 years
- Only one eye will be applicable for recruitment
- Informed signed consent according to International Conference on Harmonisation Good Clinical Practice should be in place prior to study .
Who cannot join
- Bilateral disease
- Treatment with intravitreal injections in the past three months
- Patients who have previously undergone vitrectomy
- Choroidal neovascular membrane secondary to other disease than AMD
- Macula edema of other etiology than wet AMD
- Intraocular pressure ≥ 30 mmHg in mydriasis
Show all 15Show fewer
- Active uveitis or infectious condition in the study eye
- Patients using systemic anti inflammatory therapy ( steroids)
- Patients using systemic anti-VEGF treatment
- Blod pressure which is not well regulated
- Dialysis or in need of transplantation resulting from renal failure
- Heart attack, stroke, transient ischemic attack in the last 6 months
- New York Heart Association class II , III , IV
- Known allergy to aflibercept , fluorescein or povidone iodine
- Unable to follow the study procedures
About this study
Official title: Plasma Levels of Vascular Endothelial Growth Factor Before and After Intravitreal Injection of Aflibercept in Patients With Exudative Age-related Macular Degeneration
The purpose of this study is to examine the plasma concentration of vascular endothelial growth factor (VEGF) after standard treatment with one of the newest growth factor inhibitors, aflibercept (Eylea).
Patients with exudative age-related macular degeneration (AMD) are treated today with anti-growth factors (anti-VEGF). Eylea appears to have a longer duration of action in the eye and a more powerful effect on the edema in the macula than previously used growth factor inhibitors. This means that the disease can be controlled with fewer number of injections into the eye and the investigators can therefore reduce the risk of complications associated with this type of treatment.
It is unclear what the plasma VEGF concentration after treatment with Eylea into the eye in patients with wet age-related macular degeneration is.
Read the detailed description
Macular edema secondary to exudative age-related macular degeneration is treated today primarily with vascular endothelial growth factor inhibitors, anti-VEGF.
There are currently four anti-VEGF drugs that are either approved or off-label used in ophthalmology. Pegaptanib (Macugen, Pfizer), ranibizumab (Lucentis, Novartis) aflibercept (Eylea, Bayer) and bevacizumab Avastin, Roche) . They have different molecules and pharmacodynamics .
VEGF plays an important role in many physiological and pathophysiological mechanisms. Studies have shown that even low-dose intravitreal treatment with bevacizumab leads to significant reduction of VEGF plasma concentration up to a month after treatment in patients with exudative AMD.
No significant systemic effect could be detected after intravitreal administration of ranibizumab or pegaptanib.
The purpose of this study is :
- To determine if intravitreal treatment with Eylea affects VEGF plasma levels in patients with exudative AMD
- How long after intravitreal injection is VEGF plasma concentration affected?
- Being tested
- intravitreal injection
- Keywords
- AMD, VEGF, Aflibercept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravitreal injectionProcedure or surgery
collecting blood samples
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept | Experimental | There is only one arm. Plasma VEGF is investigated in the same patient before and after intravitreal Aflibercept injection. Receives: Procedure: intravitreal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in VEGF plasma concentration (pg/mL)
Measured: 6 months
Secondary outcomes (3)
Mean change in Visual Acuity as measured with the Snellen chart
Measured: 6 months
Central Retinal Thickness as measured by Optical coherence tomography expressed in microns
Measured: 6 months
Number of non-responders
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exudative Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANCA ROALD, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125864
- Sponsor's protocol ID
- 2014-000103-27
- Other IDs
- 2014
- Acronym
- Eylea-2014
- Status last verified
- Apr 2022
- First submitted
- 24 Apr 2014
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roald AB, Aass HC, Moe MC. Recovery of plasma vascular endothelial growth factor concentrations during aflibercept loading phase and after the transition to bimonthly treatment for neovascular age-related macular degeneration. Br J Ophthalmol. 2015 Dec;99(12):1610-3. doi: 10.1136/bjophthalmol-2015-306781. Epub 2015 May 12.
PubMed 25966740
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Levels of Vascular Endothelial Growth Factor Before and After Intravitreal Injection of Aflibercept in Patients With Exudative Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02125864
- Acronym / sponsor ID
- Eylea-2014 / 2014-000103-27
- Keywords
- AMD, VEGF, Aflibercept
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 29 Apr 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.
The purpose of this study is to examine the plasma concentration of vascular endothelial growth factor (VEGF) after standard treatment with one of the newest growth factor inhibitors, aflibercept (Eylea).
Patients with exudative age-related macular degeneration (AMD) are treated today with anti-growth factors (anti-VEGF). Eylea appears to have a longer duration of action in the eye and a more powerful effect on the edema in the macula than previously used growth factor inhibitors. This means that the disease can be controlled with fewer number of injections into the eye and the investigators can therefore reduce the risk of complications associated with this type of treatment.
It is unclear what the plasma VEGF concentration after treatment with Eylea into the eye in patients with wet age-related macular degeneration is.
Detailed description
Macular edema secondary to exudative age-related macular degeneration is treated today primarily with vascular endothelial growth factor inhibitors, anti-VEGF.
There are currently four anti-VEGF drugs that are either approved or off-label used in ophthalmology. Pegaptanib (Macugen, Pfizer), ranibizumab (Lucentis, Novartis) aflibercept (Eylea, Bayer) and bevacizumab Avastin, Roche) . They have different molecules and pharmacodynamics .
VEGF plays an important role in many physiological and pathophysiological mechanisms. Studies have shown that even low-dose intravitreal treatment with bevacizumab leads to significant reduction of VEGF plasma concentration up to a month after treatment in patients with exudative AMD.
No significant systemic effect could be detected after intravitreal administration of ranibizumab or pegaptanib.
The purpose of this study is :
- To determine if intravitreal treatment with Eylea affects VEGF plasma levels in patients with exudative AMD
- How long after intravitreal injection is VEGF plasma concentration affected?
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aflibercept | Experimental | Procedure: intravitreal injectionThere is only one arm. Plasma VEGF is investigated in the same patient before and after intravitreal Aflibercept injection. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women with exudative AMD
- Central Retinal Thickness ≥ 250 microns
- Best corrected visual acuity 20/25-20/320
- Age ≥ 60 years
- Only one eye will be applicable for recruitment
Key exclusion criteria (15 listed)
- Bilateral disease
- Treatment with intravitreal injections in the past three months
- Patients who have previously undergone vitrectomy
- Choroidal neovascular membrane secondary to other disease than AMD
- Macula edema of other etiology than wet AMD
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 |
|---|---|---|
| intravitreal injectioncollecting blood samples | Procedure or surgery | Aflibercept |
Primary outcome
Mean change in VEGF plasma concentration (pg/mL)
Time frame: 6 months
3 secondary outcomes
Mean change in Visual Acuity as measured with the Snellen chart
Time frame: 6 months
Central Retinal Thickness as measured by Optical coherence tomography expressed in microns
Time frame: 6 months
Number of non-responders
Time frame: 6 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 27 Apr 2022.
- Derived from this study: PubMed 25966740Roald AB, Aass HC, Moe MC. Recovery of plasma vascular endothelial growth factor concentrations during aflibercept loading phase and after the transition to bimonthly treatment for neovascular age-related macular degeneration. Br J Ophthalmol. 2015 Dec;99(12):1610-3. doi: 10.1136/bjophthalmol-2015-306781. Epub 2015 May 12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intravitreal injection in people with Exudative Age-related Macular Degeneration, run by Oslo University Hospital.
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 15 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 27 Apr 2022. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean change in VEGF plasma concentration (pg/mL) (time frame: 6 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 NCT02125864, 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 27 Apr 2022.