Aflibercept in Recurrent or Persistent CNV

Medical University of Vienna80 enrolled

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Interventions

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

Number of retreatments

Time frame: after one year