Actively Recruiting

Age: 50Years +
All Genders
NCT02669953

Aflibercept in Recurrent or Persistent CNV

Led by Medical University of Vienna · Updated on 2024-11-26

80

Participants Needed

1

Research Sites

521 weeks

Total Duration

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AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Aflibercept in Recurrent or Persistent CNV

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 50 years or older
  • Treated with ranibizumab for wet age-related macular degeneration for up to one year
  • Best-corrected visual acuity (BCVA) at least 20/400 in the study eye using ETDRS charts
  • Willing and able to attend regular study visits
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Eye surgery in the study eye within 3 months before baseline
  • History of uncontrolled glaucoma in the study eye with intraocular pressure 25 mmHg or higher despite treatment
  • Aphakia or absence of posterior capsule (excluding YAG-capsulotomy) in the study eye
  • Retinal pigment epithelial tear involving the macula in the study eye

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Medical University of Vienna

Vienna, Austria, 1090

Actively Recruiting

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Research Team

R

Reinhard Told, MD, PhD

CONTACT

S

Stefan Sacu, Prof. PD. MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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