Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-02-25 @ 4:59 PM
Study NCT ID:
NCT02540369
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2015-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057135', 'term': 'Wet Macular Degeneration'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533178', 'term': 'aflibercept'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-14', 'studyFirstSubmitDate': '2015-08-05', 'studyFirstSubmitQcDate': '2015-09-02', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change of visual acuity.', 'timeFrame': 'Baseline and 12 months', 'description': 'Treatment in naïve and previously treated patients for wAMD and DME.'}], 'secondaryOutcomes': [{'measure': 'Change of visual acuity.', 'timeFrame': 'Baseline and 12 months', 'description': 'For the overall population'}, {'measure': 'Change of visual acuity by number of Injections.', 'timeFrame': 'Baseline and 12 months', 'description': 'In 2 sub groups'}, {'measure': 'Change in Retinal thickness.', 'timeFrame': 'Baseline and 12 months'}, {'measure': 'Treatment patterns used in routine clinical practice setting.', 'timeFrame': 'Up to 12 months', 'description': 'Number of visits and examinations per patient'}, {'measure': 'Maximum interval between treatments.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Mean time between injections.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Number of injections at 12 months.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Time to achieve stability of disease.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Number of injections in a year to achieve stability of disease.', 'timeFrame': 'Up to 12 months'}, {'measure': 'In previously treated subpopulation duration of previous treatments', 'timeFrame': 'At Baseline'}, {'measure': 'In previously treated subpopulation type of previous treatments.', 'timeFrame': 'At Baseline'}, {'measure': 'In previously treated subpopulation reason to switch to Eylea.', 'timeFrame': 'At Baseline', 'description': 'Some of the reasons are recurrence of fluid, new hemorrhage - bleed, decreased vision, lack of compliance, patient request, etc.'}, {'measure': 'Proportion of patients with no fluid determined by Optical coherence tomography (OCT).', 'timeFrame': 'At 4 months, At 12 months', 'description': "Absence of fluid would be determined by physician's judgment in the AMD population."}, {'measure': 'Numbers of patients require adjunctive therapies.', 'timeFrame': 'Up to 12 months', 'description': 'For Diabetic macular edema patients'}, {'measure': 'Type of adjunctive therapies required by patients', 'timeFrame': 'Up to 12 months', 'description': 'For Diabetic macular edema patients adjunctive therapies as focal laser, steroids, etc.'}, {'measure': 'Number of participants with adverse events as a measure of safety and tolerability.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Presence of pigment epithelial detachment (PED) (Y/N)', 'timeFrame': 'Baseline and at 12 months', 'description': 'For Age-related macular degeneration patients.'}, {'measure': 'Diabetic retinopathy severity (mild, moderate, severe).', 'timeFrame': 'Up to 12 months', 'description': 'For Diabetic macular edema patients.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetic macular edema', 'Wet Age-related macular degeneration'], 'conditions': ['Wet Macular Degeneration']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.bayer.com/', 'label': 'Click here to find results for studies related to Bayer products.'}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with wAMD (wet age-related macular degeneration) and DME (Diabetic macular edema) treated by retina specialist/ophthalmologist in selected Canadian clinical sites', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age: \\>= 18 years of age\n* Male or female\n* 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.\n* Decision to treat with intravitreal aflibercept prior to patient enrolment as per the physician's routine clinical practice.\n\nExclusion Criteria:\n\n* Patients participating in an investigational program with interventions outside of routine clinical practice.\n* 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.\n* Patients who are hypersensitive to this drug, to any ingredient in the formulation, or to any component of the container.\n* Patients who are hypersensitive to this drug, to any ingredient in the formulation, or to any component of the container.\n* Ocular or peri-ocular infection\n* Active intraocular inflammation\n* Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.\n* Any concomitant therapy with another agent to treat wet AMD or DME in the study eye."}, 'identificationModule': {'nctId': 'NCT02540369', 'acronym': 'PEGASUS', 'briefTitle': '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.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '17995'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BAY86-5321- with wAMD', 'description': 'Patients with wet Age Related Macular Degeneration (wAMD) both naïve and previously treated patients', 'interventionNames': ['Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)']}, {'label': 'BAY86-5321 - with DME', 'description': 'Patients with Diabetic Macular Edema (DME) both naïve and previously treated patients', 'interventionNames': ['Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)']}], 'interventions': [{'name': 'Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)', 'type': 'DRUG', 'description': 'Administration by intravitreal injection.Muti-target Anti-VEGF agent. Dosing would be at physicians discretion.', 'armGroupLabels': ['BAY86-5321 - with DME', 'BAY86-5321- with wAMD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Canada'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}