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NCT Number: NCT02669953

Aflibercept in Recurrent or Persistent CNV

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).

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Key information

Conditions

Age Related Macular Degeneration Diabetic Macular Edema Eye Diseases Intravitreal Injections Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Location status: Recruiting

Location contact

Reinhard Told, MD, PhD

CONTACT

+43140400 ext. 48470

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aflibercept

Drug

Primary outcomes

  1. Percent change in Best-Corrected Visual Acuity (BCVA)

    Time frame: After one year compared to baseline

  2. 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

  1. Number of retreatments

    Time frame: after one year

Study contacts

Contact information is provided by the study sponsor or research team.

Reinhard Told, MD, PhD

CONTACT

[email protected]

+43140400 ext. 48470

Stefan Sacu, Prof. PD. MD

CONTACT

[email protected]

+43140400 ext. 48470

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Response to Aflibercept After Previous Intravitreal Ranibizumab Treatment in Neovascular Age-Related Macular Degeneration

Acronym: OPHTH-010915

Important dates

Study start
2015
Primary completion
2025
Study completion
2025
First posted
Feb 1, 2016
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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