Macular DegenerationREALENCT03411941
Evaluate the Effectiveness of Intravitreal (IVT) Aflibercept Injection in Clinical Practice in naïve Patients With Neovascular Age-related Macular Degeneration (nAMD)
An observational study of Macular Degeneration, run by Bayer at 1 site in Spain.
Trial summary
There is a need to investigate the effectiveness of IVT aflibercept injection in routine clinical practice. The aim of this study is to collect 12-month real-world clinical data from treatment-naïve nAMD patients who started first-line treatment with IVT aflibercept injection, according to the SmPC (Summary of Product… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
- Type of treatment
- Injection or infusion
- How many people
- 116 participants
- Where
- 1 siteSpain
- Study dates
- 28 Feb 2018to 1 Mar 2019
- Phase
- Observational
- 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
Study population: The study will include data from adult patients newly diagnosed with nAMD who initiated and maintained anti-VEGF treatment with IVT aflibercept injection in 8 Spanish centers which treat AMD patients routinely.
Who may be able to join
- Adult patient aged 50 years or more at aflibercept treatment initiation.
- Treatment-naïve patients with nAMD
- Patients who initated treatment with IVT aflibercept injection between 1st April 2014 to 31st May 2016
- Patients that have been decided to be treated with IVT aflibercept with a minimum treatment follow-up with IVT aflibercept injection of at least 12-months, in accordance with the approved SmPC.
- Patients who have been provided with appropriate information about the study objectives and procedures and who have given their written informed consent.
Who cannot join
- Patients who have previously been treated with anti-VEGF intravitreal injections, systemic anti-VEGF or pro-VEGF treatments, as well as other intravitreal steroids or steroid implants for the study eye.
- Patients that switched to another treatment alternative different from IVT aflibercept injection during observation period of 12 months
- Patients with another retinal disease: diabetic retinopathy, diabetic macular edema (DME), myopic choroidal neovascularization, retinal vein occlusion (RVO), central serous chorioretinopathy (CSC), angioid streaks.
- Patients with scarring, fibrosis, or atrophy involving the center of the fovea in the study eye at treatment initiation
- Patients with advanced cataract or advanced glaucoma
- Patients with presence of retinal pigment epithelial tears or rips involving the macula in the study eye prior to treatment initiation.
- Patients who do not meet the local Guideline criteria for aflibercept treatment. Contraindications listed in the SmPC must be taken into account.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational, Retrospective Study to Evaluate the Effectiveness of Intravitreal (IVT) Aflibercept Injection in Clinical Practice in naïve Patients With Neovascular Age-related Macular Degeneration (nAMD)
There is a need to investigate the effectiveness of IVT aflibercept injection in routine clinical practice.
The aim of this study is to collect 12-month real-world clinical data from treatment-naïve nAMD patients who started first-line treatment with IVT aflibercept injection, according to the SmPC (Summary of Product Characteristics) and the SERV (Spanish Society of Retina and Vitreous) guidelines. The effectiveness of IVT aflibercept will be assessed by the changes in VA (Visual Acuity) and CRT (Central Retinal Thickness) during treatment.
- Conditions
- Macular Degeneration
- Being tested
- Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
- Keywords
- nAMD: neovascular Age-related Macular Degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Drug
IVT(Intravitreal) aflibercept treatment in routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Treatment-naïve nAMD patients | Patient data for whom treatment with IVT aflibercept injection was initiated as first-line treatment according to the SmPC and the SERV Guideline, in treatment-naive patients with newly diagnosed of nAMD in routine clinical practice. Receives: Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in VA
The mean change in VA from baseline (i.e. just prior to the start of treatment) to 12 months in treatment-naïve patients with nAMD in routine clinical practice in Spain.
Measured: From baseline to month 12
Secondary outcomes (13)
Mean change in VA
Measured: From baseline to month 6
Proportion of patients gaining 15 or more letters
Measured: At month 6 and 12
Mean change in CRT in µm (measured by OCT)
OCT:Optical Coherence Tomography
Measured: From baseline to months 6 and 12
Presence/absence of SRF (subretinal fluid) by OCT (yes/no)
Measured: At months 6 and 12
Presence/absence of IRF (intraretinal fluid) by OCT (yes/no)
Measured: At months 6 and 12
Presence/absence of PED (pigment epithelium detachment) (measured by OCT)
Absence of PED: when the maximum distance between the outer border of the RPE and the inner border of the Bruch membrane is <30 μm
Measured: At months 6 and 12
Presence/absence of PED Height
Subfoveal and 500µm nasal and temporal; PED height defined as the distance between the outer border of the retinal pigment epithelium (RPE) and the inner border of the Bruch membrane
Measured: At months 6 and 12
Presence/absence of PED type
Serous-vascularized or fibrovascular
Measured: At months 6 and 12
Correlation of the mean gain in VA with the total number of injections administered
Measured: 12 months
Mean number of IVT aflibercept injections per study eye
Measured: The first 12 months
Mean number of monitoring visits per study eye
Visits only for diagnostic/follow-up purposes, but without injections
Measured: The first 12 months
Mean number of combined visits per study eye
Visits for monitoring and injection
Measured: The first 12 months
Mean number of OCT assessments per study eye
Measured: The first 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start28 Feb 2018
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411941
- Sponsor's protocol ID
- 18798
- Acronym
- REALE
- Status last verified
- Dec 2019
- First submitted
- 21 Jan 2018
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Retrospective Study to Evaluate the Effectiveness of Intravitreal (IVT) Aflibercept Injection in Clinical Practice in naïve Patients With Neovascular Age-related Macular Degeneration (nAMD)
- ClinicalTrials.gov ID
- NCT03411941
- Acronym / sponsor ID
- REALE / 18798
- Conditions
- Macular Degeneration
- Keywords
- nAMD: neovascular Age-related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 26 Jan 2018 (actual)
- 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.
There is a need to investigate the effectiveness of IVT aflibercept injection in routine clinical practice.
The aim of this study is to collect 12-month real-world clinical data from treatment-naïve nAMD patients who started first-line treatment with IVT aflibercept injection, according to the SmPC (Summary of Product Characteristics) and the SERV (Spanish Society of Retina and Vitreous) guidelines. The effectiveness of IVT aflibercept will be assessed by the changes in VA (Visual Acuity) and CRT (Central Retinal Thickness) during treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment-naïve nAMD patients | – | Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Patient data for whom treatment with IVT aflibercept injection was initiated as first-line treatment according to the SmPC and the SERV Guideline, in treatment-naive patients with newly diagnosed of nAMD in routine clinical practice. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include data from adult patients newly diagnosed with nAMD who initiated and maintained anti-VEGF treatment with IVT aflibercept injection in 8 Spanish centers which treat AMD patients routinely.
Key inclusion criteria (5 listed)
- Adult patient aged 50 years or more at aflibercept treatment initiation.
- Treatment-naïve patients with nAMD
- Patients who initated treatment with IVT aflibercept injection between 1st April 2014 to 31st May 2016
- Patients that have been decided to be treated with IVT aflibercept with a minimum treatment follow-up with IVT aflibercept injection of at least 12-months, in accordance with the approved SmPC.
- Patients who have been provided with appropriate information about the study objectives and procedures and who have given their written informed consent.
Key exclusion criteria (7 listed)
- Patients who have previously been treated with anti-VEGF intravitreal injections, systemic anti-VEGF or pro-VEGF treatments, as well as other intravitreal steroids or steroid implants for the study eye.
- Patients that switched to another treatment alternative different from IVT aflibercept injection during observation period of 12 months
- Patients with another retinal disease: diabetic retinopathy, diabetic macular edema (DME), myopic choroidal neovascularization, retinal vein occlusion (RVO), central serous chorioretinopathy (CSC), angioid streaks.
- Patients with scarring, fibrosis, or atrophy involving the center of the fovea in the study eye at treatment initiation
- Patients with advanced cataract or advanced glaucoma
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 |
|---|---|---|
| Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)IVT(Intravitreal) aflibercept treatment in routine clinical practice. | Drug | Treatment-naïve nAMD patients |
Primary outcome
Mean change in VA
Time frame: From baseline to month 12
The mean change in VA from baseline (i.e. just prior to the start of treatment) to 12 months in treatment-naïve patients with nAMD in routine clinical practice in Spain.
13 secondary outcomes
Mean change in VA
Time frame: From baseline to month 6
Proportion of patients gaining 15 or more letters
Time frame: At month 6 and 12
Mean change in CRT in µm (measured by OCT)
Time frame: From baseline to months 6 and 12
Presence/absence of SRF (subretinal fluid) by OCT (yes/no)
Time frame: At months 6 and 12
Presence/absence of IRF (intraretinal fluid) by OCT (yes/no)
Time frame: At months 6 and 12
Presence/absence of PED (pigment epithelium detachment) (measured by OCT)
Time frame: At months 6 and 12
Presence/absence of PED Height
Time frame: At months 6 and 12
Presence/absence of PED type
Time frame: At months 6 and 12
Correlation of the mean gain in VA with the total number of injections administered
Time frame: 12 months
Mean number of IVT aflibercept injections per study eye
Time frame: The first 12 months
Mean number of monitoring visits per study eye
Time frame: The first 12 months
Mean number of combined visits per study eye
Time frame: The first 12 months
Mean number of OCT assessments per study eye
Time frame: The first 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 5 Dec 2019.
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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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Degeneration, run by Bayer at 1 site in Spain.
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 5 inclusion and 7 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 5 Dec 2019. 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 Spain. 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?
Mean change in VA (time frame: From baseline to month 12). 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 5 Dec 2019.