Aflibercept in Recurrent or Persistent CNV
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorMedical University of Vienna
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
20 Patients with nAMD
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Aflibercept
Drug
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: AMD patients previously teated with Lucentis1 intervention
Group B: treatment naive AMD patients1 intervention
Group C: DME patients previously teated with Lucentis1 intervention
Group D: treatment naive DME patients1 intervention
Trial outcomes
Primary outcomes
1
Percent change in Best-Corrected Visual Acuity (BCVA)
Time frame
After one year compared to baseline2
Anatomic changes in the macula as assessed with OCT (central retinal thickness, morphologic changes, fundus photos)
Time frame
after one year compared to baselineSecondary outcomes
1
Number of retreatments
Time frame
after one yearSponsors and contacts
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Source ClinicalTrials.gov