Clinical trial NCT02669953: Aflibercept in Recurrent or Persistent CNV
Official title: Response to Aflibercept After Previous Intravitreal Ranibizumab Treatment in Neovascular Age-Related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Age Related Macular Degeneration
Intravitreal Injections
Diabetic Macular Edema
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2016-02-01
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 Patients with nAMD

Brief summary: 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: 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

Primary outcomes:
measure: Percent change in Best-Corrected Visual Acuity (BCVA)
timeFrame: After one year compared to baseline
measure: Anatomic changes in the macula as assessed with OCT (central retinal thickness, morphologic changes, fundus photos)
timeFrame: after one year compared to baseline
Secondary outcomes:
measure: Number of retreatments
timeFrame: after one year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References: