Aflibercept in Recurrent or Persistent CNV
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aflibercept.
- Who it may be relevant to
- Registry conditions: Age Related Macular Degeneration, Intravitreal Injections, Diabetic Macular Edema. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Response to Aflibercept After Previous Intravitreal Ranibizumab Treatment in Neovascular Age-Related Macular Degeneration
Overview
Age-related macular degeneration (AMD) and diabetic retinopathy are among the most common disorders causing visual disability in elderly people. AMD leads to dysfunction and loss of photoreceptors in the central retina. Neovascular AMD (nAMD) affects visual function early in the disease process. 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).
Interventions
- Drug Aflibercept
Primary outcome measures
- Percent change in Best-Corrected Visual Acuity (BCVA) [Time frame: After one year compared to baseline]
- Anatomic changes in the macula as assessed with OCT (central retinal thickness, morphologic changes, fundus photos) [Time frame: after one year compared to baseline]
Secondary outcome measures (1)
- Number of retreatments [Time frame: after one year]
Eligibility criteria
Inclusion criteria
Adults ≥ 50 years
- 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
- Any surgical treatment of the eye within 3 months prior to baseline in the study eye
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Austria · 1 center
- Medical University of Vienna — Vienna
Identifiers
NCT: NCT02669953 · OPHTH-010915 (Ex-Oct)