Macular DegenerationAQUILANCT03470103
A Study in Patients With Wet Age-related Macular Degeneration or Diabetic Macular Edema to Assess the freQuency of Use of Intravitreal Aflibercept in Routine Clinical Practices in Latin America
An observational study of Macular Degeneration, run by Bayer at 4 sites in 4 countries.
Trial summary
The main objectives of this observational cohort study are to describe the use of intravitreal aflibercept and to describe follow-up as well as treatment patterns in patients with wAMD or DME in routine clinical practice in Latin America for a study population of treatment naive patients and those who have received… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
- How many people
- 643 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 28 Mar 2018to 15 Jan 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of patients with wAMD or DME treated with intravitreal aflibercept. If both eyes are eligible, data from both eyes will be captured, but only one eye will be considered the study eye and included in the study analyses. The eye included will be at the physician's discretion and only visits related to the study eye will be captured in the electronic Case Report Form (eCRF).
Who may be able to join
- Age: ≥18 years of age for DME patients,
- Age: ≥55 for wAMD patients
- Decision to treat with intravitreal aflibercept in the study eye prior to patient enrolment as per the physician's routine clinical practice and following the local Product monograph recommendations. Patients who are treatment naïve (no previous intravitreal treatment received, including, anti- VEGF agents, steroids, steroid implants and/or PDT) and patients that are switching from a different anti-VEGF therapy are both eligible to be included. DME patients that have received previous laser only will be classified as treatment naïve.
- If of childbearing potential, female willing to use effective contraception during treatment and for at least 3 months after the last intravitreal injection of aflibercept
Who cannot join
- Patients participating in an investigational program with interventions outside of routine clinical practice.
- Patients currently being treated with intravitreal aflibercept in the study eye.
- Patients who are hypersensitive to this drug, to any ingredient in the formulation, or to any component of the container. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the local product monograph.
- Ocular or peri-ocular infection in either eye.
- Active intraocular inflammation in the study eye.
- Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
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- Patients with advanced glaucoma, visually significant cataracts, or any eye disease likely to require surgery during the study period in the study eye.
- Concomitant ocular or systemic administration of drugs that could interfere with or potentiate the mechanism of action of intravitreal aflibercept, including anti-VEGF agents.
- Patients receiving a different anti-VEGF agent other than intravitreal aflibercept for the fellow eye.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: A Prospective Observational Study in Patients With Wet Age-related Macular Degeneration or Diabetic Macular Edema to Assess the freQuency of Use of Intravitreal Aflibercept in Routine Clinical Practices in Latin America
The main objectives of this observational cohort study are to describe the use of intravitreal aflibercept and to describe follow-up as well as treatment patterns in patients with wAMD or DME in routine clinical practice in Latin America for a study population of treatment naive patients and those who have received prior therapy (anti-VEGF injections, laser, steroids, etc.) and are being switched to intravitreal aflibercept injection.
- Conditions
- Macular Degeneration
- Being tested
- Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
- Keywords
- Wet age-related macular degeneration(wAMD), Diabetic macular edema(DME)
- 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
Use of intravitreal aflibercept in routine clinical practice in Latin America
| Study group | Role | What they receive |
|---|---|---|
| Treatment naïve wAMD | The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice Receives: Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) | |
| Treatment naïve DME | The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice Receives: Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) | |
| Previously treated wAMD | The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice Receives: Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) | |
| Previously treated DME | The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical 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 of visual acuity as measured by ETDRS or Snellen chart
ETDRS: Early treatment diabetic retinopathy study
Measured: At baseline and 12 months
Secondary outcomes (20)
Mean change in visual acuity as measured by ETDRS or Snellen chart
Mean change in visual acuity between baseline and 12 months for the overall population (treatment naïve + previously treated patients) by indication, wAMD and DME.
Measured: At baseline and 12 months
Change in retinal thickness as measured by OCT
OCT: Optical coherence tomography
Measured: At baseline and 12 months
Mean time between injections by indication
Measured: Up to 12 months
Mean number of injections by indication
Measured: At 12 months
Duration of previous treatments by indication
In the previously treated subpopulation
Measured: Up to 12 months
Type (anti-VEGF, laser, steroids, etc) of previous treatments by indication
In the previously treated subpopulation
Measured: Up to 12 months
Percentage of patients with no fluid determined by OCT
Absence of fluid includes all types of fluid and would be determined by physicians judgment
Measured: At 12 months
Percentage of patients achieving a Snellen equivalent of 20/40 or better
About 70 ETDRS(Early treatment diabetic retinopathy study) letters
Measured: At 12 months
Percentage of patients gaining ≥15 ETDRS letter
Measured: At 12 months
Presence/absence of pigment epithelium detachments (PED)
In the wAMD population
Measured: At 12 months
Number of adjunctive therapies
In the DME population
Measured: At 12 months
Type of adjunctive therapies based on medical records or on interviewing the patient
Measured: At 12 months
Diabetic retinopathy severity (mild, moderate, severe)
In the DME population
Measured: At 12 months
Reason to switch to intravitreal aflibercept based on medical records or on interviewing the patient
Measured: At 12 months
Number of monitoring visits
Visits only for diagnostic purposes, but without injections
Measured: At 12 months
Number of combined visits
Visits for monitoring and injection
Measured: At 12 months
Number of visits outside the study center
Visits with other non-ophthalmology specialists, i.e. endocrinologists, family physician, etc.
Measured: At 12 months
Number of optical coherence tomography (OCT) assessments per patient
Measured: At 12 months
Number of visual acuity tests
Measured: At 12 months
Number of fundoscopy examinations
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start28 Mar 2018
- Primary completion21 Sep 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 643 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470103
- Sponsor's protocol ID
- 19518
- Acronym
- AQUILA
- Status last verified
- Jun 2021
- First submitted
- 5 Feb 2018
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Publications
Wu L, Bordon AF, Charles M, Rodriguez FJ, Lee J, Machewitz T, Mueller M, Del Carmen Gay G, Fromow-Guerra J; AQUILA investigators. Intravitreal aflibercept for the treatment of patients with neovascular age-related macular degeneration in routine clinical practice in Latin America: the AQUILA study. Int J Retina Vitreous. 2022 Oct 18;8(1):76. doi: 10.1186/s40942-022-00425-w.
PubMed 36258240Rodriguez FJ, Wu L, Bordon AF, Charles M, Lee J, Machewitz T, Mueller M, Gay GDC, Fromow-Guerra J; AQUILA Investigators. Intravitreal aflibercept for the treatment of patients with diabetic macular edema in routine clinical practice in Latin America: the AQUILA study. Int J Retina Vitreous. 2022 Aug 2;8(1):52. doi: 10.1186/s40942-022-00396-y.
PubMed 35918743
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study in Patients With Wet Age-related Macular Degeneration or Diabetic Macular Edema to Assess the freQuency of Use of Intravitreal Aflibercept in Routine Clinical Practices in Latin America
- ClinicalTrials.gov ID
- NCT03470103
- Acronym / sponsor ID
- AQUILA / 19518
- Conditions
- Macular Degeneration
- Keywords
- Wet age-related macular degeneration(wAMD), Diabetic macular edema(DME)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 643 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 21 Sep 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 19 Mar 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.
The main objectives of this observational cohort study are to describe the use of intravitreal aflibercept and to describe follow-up as well as treatment patterns in patients with wAMD or DME in routine clinical practice in Latin America for a study population of treatment naive patients and those who have received prior therapy (anti-VEGF injections, laser, steroids, etc.) and are being switched to intravitreal aflibercept injection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment naïve wAMD | – | Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice |
| Treatment naïve DME | – | Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice |
| Previously treated wAMD | – | Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice |
| Previously treated DME | – | Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients with wAMD or DME treated with intravitreal aflibercept. If both eyes are eligible, data from both eyes will be captured, but only one eye will be considered the study eye and included in the study analyses. The eye included will be at the physician's discretion and only visits related to the study eye will be captured in the electronic Case Report Form (eCRF).
Key inclusion criteria (4 listed)
- Age: ≥18 years of age for DME patients,
- Age: ≥55 for wAMD patients
- Decision to treat with intravitreal aflibercept in the study eye prior to patient enrolment as per the physician's routine clinical practice and following the local Product monograph recommendations. Patients who are treatment naïve (no previous intravitreal treatment received, including, anti- VEGF agents, steroids, steroid implants and/or PDT) and patients that are switching from a different anti-VEGF therapy are both eligible to be included. DME patients that have received previous laser only will be classified as treatment naïve.
- If of childbearing potential, female willing to use effective contraception during treatment and for at least 3 months after the last intravitreal injection of aflibercept
Key exclusion criteria (9 listed)
- Patients participating in an investigational program with interventions outside of routine clinical practice.
- Patients currently being treated with intravitreal aflibercept in the study eye.
- Patients who are hypersensitive to this drug, to any ingredient in the formulation, or to any component of the container. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the local product monograph.
- Ocular or peri-ocular infection in either eye.
- Active intraocular inflammation in the 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 |
|---|---|---|
| Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Use of intravitreal aflibercept in routine clinical practice in Latin America | Drug | Previously treated DME, Previously treated wAMD, Treatment naïve DME, Treatment naïve wAMD |
Primary outcome
Mean change of visual acuity as measured by ETDRS or Snellen chart
Time frame: At baseline and 12 months
ETDRS: Early treatment diabetic retinopathy study
20 secondary outcomes
Mean change in visual acuity as measured by ETDRS or Snellen chart
Time frame: At baseline and 12 months
Change in retinal thickness as measured by OCT
Time frame: At baseline and 12 months
Mean time between injections by indication
Time frame: Up to 12 months
Mean number of injections by indication
Time frame: At 12 months
Duration of previous treatments by indication
Time frame: Up to 12 months
Type (anti-VEGF, laser, steroids, etc) of previous treatments by indication
Time frame: Up to 12 months
Percentage of patients with no fluid determined by OCT
Time frame: At 12 months
Percentage of patients achieving a Snellen equivalent of 20/40 or better
Time frame: At 12 months
Percentage of patients gaining ≥15 ETDRS letter
Time frame: At 12 months
Presence/absence of pigment epithelium detachments (PED)
Time frame: At 12 months
Number of adjunctive therapies
Time frame: At 12 months
Type of adjunctive therapies based on medical records or on interviewing the patient
Time frame: At 12 months
Diabetic retinopathy severity (mild, moderate, severe)
Time frame: At 12 months
Reason to switch to intravitreal aflibercept based on medical records or on interviewing the patient
Time frame: At 12 months
Number of monitoring visits
Time frame: At 12 months
Number of combined visits
Time frame: At 12 months
Number of visits outside the study center
Time frame: At 12 months
Number of optical coherence tomography (OCT) assessments per patient
Time frame: At 12 months
Number of visual acuity tests
Time frame: At 12 months
Number of fundoscopy examinations
Time frame: At 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 25 Jun 2021.
- Derived from this study: PubMed 36258240Wu L, Bordon AF, Charles M, Rodriguez FJ, Lee J, Machewitz T, Mueller M, Del Carmen Gay G, Fromow-Guerra J; AQUILA investigators. Intravitreal aflibercept for the treatment of patients with neovascular age-related macular degeneration in routine clinical practice in Latin America: the AQUILA study. Int J Retina Vitreous. 2022 Oct 18;8(1):76. doi: 10.1186/s40942-022-00425-w.
- Derived from this study: PubMed 35918743Rodriguez FJ, Wu L, Bordon AF, Charles M, Lee J, Machewitz T, Mueller M, Gay GDC, Fromow-Guerra J; AQUILA Investigators. Intravitreal aflibercept for the treatment of patients with diabetic macular edema in routine clinical practice in Latin America: the AQUILA study. Int J Retina Vitreous. 2022 Aug 2;8(1):52. doi: 10.1186/s40942-022-00396-y.
- Individual participant dataSharing planned: Undecided. Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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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.
4 sites in 4 countries: 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 4 sites in 4 countries.
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 9 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 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Argentina, Colombia, Costa Rica, Mexico. 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 of visual acuity as measured by ETDRS or Snellen chart (time frame: At baseline and 12 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 NCT03470103, which also lists 2 linked publications.
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 25 Jun 2021.