Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
80 participants
OBSERVATIONAL
2015-12-31
2025-12-31
Brief Summary
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The purpose of the study is to evaluate the effect of switching from ranibizumab therapy to the current routine therapy using aflibercept in eyes with treatment naive, recurrent or persistent nAMD, treatment naive diabetic retinopathy and pretreated diabetic retinopathy.
20 patients with recurrent or persistent nAMD, previously treated with intravitreal ranibizumab for up to one year will be included in this trial. Patients will be examined in monthly intervals over 12 months follow-up.
Examinations carried out will include: Best-corrected visual acuity (BCVA) using ETDRS charts at 4m distance, Reading Performance (RP), Standard ophthalmic examinations (SOE incl. funduscopy and applanation tonometry), Optical coherence tomography (OCT), Autofluorescence fundus image (AF) \& red-free autofluorescence fundus image (RF), Color fundus photography (CFP), Fluorescein angiography and indocyaningreen angiography (FLA/ICG), Microperimetry (MP), as well as Non-invasive OCT based optical angiography (AngioVue).
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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AMD patients previously teated with Lucentis
Adults ≥ 50 years; Patients who have been treated with ranibizumab due to wet age-related macular degeneration for up to one year; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS; Willingness and ability to comply with regular visits; Signed informed consent form;
The patient can take his medicine in the prescribed manner. The prescribed drugs do not constitute an exclusion criteria.
Aflibercept
treatment naive AMD patients
Adults ≥ 50 years; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS;
Aflibercept
DME patients previously teated with Lucentis
Adults ≥ 50 years; Patients who have been treated with ranibizumab due to DME for up to one year; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS;
Aflibercept
treatment naive DME patients
Adults ≥ 50 years; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS;
Aflibercept
Interventions
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Aflibercept
Eligibility Criteria
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Inclusion Criteria
* Patients who have been treated with ranibizumab due to wet age-related macular degeneration for up to one year
* BCVA \>= 20/400 in the study eye using ETDRS
* Willingness and ability to comply with regular visits
* Signed informed consent
Exclusion Criteria
* History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma mediation)
* Aphakia or absence of the posterior capsule (excluding YAG-capsulotomy) in the study eye
* Retinal pigment epithelial tear involving the macula in the study eye
50 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Stefan Sacu
Prof. PD. Dr.
Locations
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Medical University of Vienna
Vienna, , Austria
Countries
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Central Contacts
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Facility Contacts
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Reinhard Told, MD, PhD
Role: primary
Other Identifiers
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OPHTH-010915 (Ex-Oct)
Identifier Type: -
Identifier Source: org_study_id
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