Wet Macular DegenerationPEGASUSNCT02540369
To Describe the Use of Intravitreal Aflibercept and to Describe Follow-up as Well as Treatment Patterns in Patients With Wet Age-related Macular Degeneration (wAMD) or Diabetic Macular Edema (DME) in Routine Clinical Practice in Canada.
An observational study of Wet Macular Degeneration, run by Bayer at 1 site in Canada.
Trial summary
To describe the use of intravitreal aflibercept in routine clinical practice and to describe follow-up as well as treatment patterns in patients with wAMD or DME in routine clinical practice in Canada for a study population of treatment naive patients and those who have received prior therapy (anti-VEGF injections… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wet Macular Degeneration
- What is being tested?
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- Type of treatment
- Injection or infusion
- How many people
- 2,150 participants
- Where
- 1 siteCanada
- Study dates
- 14 Dec 2015to 26 Jan 2018
- 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: Patients with wAMD (wet age-related macular degeneration) and DME (Diabetic macular edema) treated by retina specialist/ophthalmologist in selected Canadian clinical sites
Who may be able to join
- Age: >= 18 years of age
- Male or female
- Patients with wet AMD (wet age-related macular degeneration) or Diabetic macular edema (DME) who will be treated by intravitreal aflibercept according to the Canadian Product monograph recommendations and routine clinical practice.
- Decision to treat with intravitreal aflibercept prior to patient enrolment as per the physician's routine clinical practice.
Who cannot join
- Patients participating in an investigational program with interventions outside of routine clinical practice.
- Patients currently being treated with intravitreal aflibercept. This study will only include patients new to intravitreal aflibercept, both naïve and previously treated with other anti-VEGF therapies.
- Patients who are hypersensitive to this drug, to any ingredient in the formulation, or to any component of the container.
- Patients who are hypersensitive to this drug, to any ingredient in the formulation, or to any component of the container.
- Ocular or peri-ocular infection
- Active intraocular inflammation
- Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
- Any concomitant therapy with another agent to treat wet AMD or DME in the study eye.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PEGASUS: A Prospective obsErvational Study in Patients With Wet aGe-related Macular Degeneration or Diabetic Macular Edema to ASsess the Use of Intravitreal Aflibercept in roUtine Clinical practiceS in Canada
To describe the use of intravitreal aflibercept in routine clinical practice and to describe follow-up as well as treatment patterns in patients with wAMD or DME in routine clinical practice in Canada for a study population of treatment naive patients and those who have received prior therapy (anti-VEGF injections, laser, steroids, etc).
- Conditions
- Wet Macular Degeneration
- Being tested
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- Keywords
- Diabetic macular edema, Wet Age-related macular degeneration
- Medical subject headings
- Wet Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)Drug
Administration by intravitreal injection.Muti-target Anti-VEGF agent. Dosing would be at physicians discretion.
| Study group | Role | What they receive |
|---|---|---|
| BAY86-5321- with wAMD | Patients with wet Age Related Macular Degeneration (wAMD) both naïve and previously treated patients Receives: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) | |
| BAY86-5321 - with DME | Patients with Diabetic Macular Edema (DME) both naïve and previously treated patients Receives: Drug: Aflibercept (Eylea, 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.
Treatment in naïve and previously treated patients for wAMD and DME.
Measured: Baseline and 12 months
Secondary outcomes (18)
Change of visual acuity.
For the overall population
Measured: Baseline and 12 months
Change of visual acuity by number of Injections.
In 2 sub groups
Measured: Baseline and 12 months
Change in Retinal thickness.
Measured: Baseline and 12 months
Treatment patterns used in routine clinical practice setting.
Number of visits and examinations per patient
Measured: Up to 12 months
Maximum interval between treatments.
Measured: Up to 12 months
Mean time between injections.
Measured: Up to 12 months
Number of injections at 12 months.
Measured: Up to 12 months
Time to achieve stability of disease.
Measured: Up to 12 months
Number of injections in a year to achieve stability of disease.
Measured: Up to 12 months
In previously treated subpopulation duration of previous treatments
Measured: At Baseline
In previously treated subpopulation type of previous treatments.
Measured: At Baseline
In previously treated subpopulation reason to switch to Eylea.
Some of the reasons are recurrence of fluid, new hemorrhage - bleed, decreased vision, lack of compliance, patient request, etc.
Measured: At Baseline
Proportion of patients with no fluid determined by Optical coherence tomography (OCT).
Absence of fluid would be determined by physician's judgment in the AMD population.
Measured: At 4 months, At 12 months
Numbers of patients require adjunctive therapies.
For Diabetic macular edema patients
Measured: Up to 12 months
Type of adjunctive therapies required by patients
For Diabetic macular edema patients adjunctive therapies as focal laser, steroids, etc.
Measured: Up to 12 months
Number of participants with adverse events as a measure of safety and tolerability.
Measured: Up to 12 months
Presence of pigment epithelial detachment (PED) (Y/N)
For Age-related macular degeneration patients.
Measured: Baseline and at 12 months
Diabetic retinopathy severity (mild, moderate, severe).
For Diabetic macular edema patients.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study start14 Dec 2015
- Primary completion25 Sep 2017
- Study completion26 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet 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
- 2,150 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
- NCT02540369
- Sponsor's protocol ID
- 17995
- Acronym
- PEGASUS
- Status last verified
- Feb 2019
- First submitted
- 5 Aug 2015
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEGASUS: A Prospective obsErvational Study in Patients With Wet aGe-related Macular Degeneration or Diabetic Macular Edema to ASsess the Use of Intravitreal Aflibercept in roUtine Clinical practiceS in Canada
- ClinicalTrials.gov ID
- NCT02540369
- Acronym / sponsor ID
- PEGASUS / 17995
- Conditions
- Wet Macular Degeneration
- Keywords
- Diabetic macular edema, Wet Age-related macular degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,150 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 14 Dec 2015 (actual)
- Primary completion
- 25 Sep 2017 (actual)
- Study completion
- 26 Jan 2018 (actual)
- First posted
- 3 Sep 2015 (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 describe the use of intravitreal aflibercept in routine clinical practice and to describe follow-up as well as treatment patterns in patients with wAMD or DME in routine clinical practice in Canada for a study population of treatment naive patients and those who have received prior therapy (anti-VEGF injections, laser, steroids, etc).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAY86-5321- with wAMD | – | Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)Patients with wet Age Related Macular Degeneration (wAMD) both naïve and previously treated patients |
| BAY86-5321 - with DME | – | Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)Patients with Diabetic Macular Edema (DME) both naïve and previously treated patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with wAMD (wet age-related macular degeneration) and DME (Diabetic macular edema) treated by retina specialist/ophthalmologist in selected Canadian clinical sites
Key inclusion criteria (4 listed)
- Age: >= 18 years of age
- Male or female
- Patients with wet AMD (wet age-related macular degeneration) or Diabetic macular edema (DME) who will be treated by intravitreal aflibercept according to the Canadian Product monograph recommendations and routine clinical practice.
- Decision to treat with intravitreal aflibercept prior to patient enrolment as per the physician's routine clinical practice.
Key exclusion criteria (8 listed)
- Patients participating in an investigational program with interventions outside of routine clinical practice.
- Patients currently being treated with intravitreal aflibercept. This study will only include patients new to intravitreal aflibercept, both naïve and previously treated with other anti-VEGF therapies.
- Patients who are hypersensitive to this drug, to any ingredient in the formulation, or to any component of the container.
- Patients who are hypersensitive to this drug, to any ingredient in the formulation, or to any component of the container.
- Ocular or peri-ocular infection
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 |
|---|---|---|
| Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)Administration by intravitreal injection.Muti-target Anti-VEGF agent. Dosing would be at physicians discretion. | Drug | BAY86-5321 - with DME, BAY86-5321- with wAMD |
Primary outcome
Mean change of visual acuity.
Time frame: Baseline and 12 months
Treatment in naïve and previously treated patients for wAMD and DME.
18 secondary outcomes
Change of visual acuity.
Time frame: Baseline and 12 months
Change of visual acuity by number of Injections.
Time frame: Baseline and 12 months
Change in Retinal thickness.
Time frame: Baseline and 12 months
Treatment patterns used in routine clinical practice setting.
Time frame: Up to 12 months
Maximum interval between treatments.
Time frame: Up to 12 months
Mean time between injections.
Time frame: Up to 12 months
Number of injections at 12 months.
Time frame: Up to 12 months
Time to achieve stability of disease.
Time frame: Up to 12 months
Number of injections in a year to achieve stability of disease.
Time frame: Up to 12 months
In previously treated subpopulation duration of previous treatments
Time frame: At Baseline
In previously treated subpopulation type of previous treatments.
Time frame: At Baseline
In previously treated subpopulation reason to switch to Eylea.
Time frame: At Baseline
Proportion of patients with no fluid determined by Optical coherence tomography (OCT).
Time frame: At 4 months, At 12 months
Numbers of patients require adjunctive therapies.
Time frame: Up to 12 months
Type of adjunctive therapies required by patients
Time frame: Up to 12 months
Number of participants with adverse events as a measure of safety and tolerability.
Time frame: Up to 12 months
Presence of pigment epithelial detachment (PED) (Y/N)
Time frame: Baseline and at 12 months
Diabetic retinopathy severity (mild, moderate, severe).
Time frame: Up to 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 15 Feb 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 Wet Macular Degeneration, run by Bayer at 1 site in Canada.
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 8 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 15 Feb 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 Canada. 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. (time frame: Baseline and 12 months). 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 15 Feb 2019.