Aflibercept in Recurrent or Persistent CNV (OPHTH-010915)

January 13, 2023 updated by: Stefan Sacu, Medical University of Vienna

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Medical University of Vienna
        • Contact:
          • Reinhard Told, MD, PhD
          • Phone Number: 48470 +43140400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

20 Patients with nAMD

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AMD patients previously teated with Lucentis

Adults ≥ 50 years; Patients who have been treated with ranibizumab due to wet age-related macular degeneration for up to one year; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS; Willingness and ability to comply with regular visits; Signed informed consent form;

The patient can take his medicine in the prescribed manner. The prescribed drugs do not constitute an exclusion criteria.
Drug: Aflibercept
treatment naive AMD patients
Adults ≥ 50 years; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS;
Drug: Aflibercept
DME patients previously teated with Lucentis
Adults ≥ 50 years; Patients who have been treated with ranibizumab due to DME for up to one year; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS;
Drug: Aflibercept
treatment naive DME patients
Adults ≥ 50 years; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS;
Drug: Aflibercept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change in Best-Corrected Visual Acuity (BCVA)
Time Frame: After one year compared to baseline
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
after one year compared to baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of retreatments
Time Frame: after one year
after one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

January 18, 2016

First Submitted That Met QC Criteria

January 27, 2016

First Posted (Estimate)

February 1, 2016

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPHTH-010915 (Ex-Oct)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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