Aflibercept in Recurrent or Persistent CNV (OPHTH-010915)

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: Diabetic Macular Edema; Age Related Macular Degeneration; Intravitreal Injections
• Intervention / Treatment: Drug: Aflibercept

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Reinhard Told, MD, PhD; Phone Number: 48470 +43140400; Email: reinhard.told@meduniwien.ac.at
• Study Contact Backup: Name: Stefan Sacu, Prof. PD. MD; Phone Number: 48470 +43140400; Email: stefan.sacu@meduniwien.ac.at

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

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)	After one year compared to baseline
Anatomic changes in the macula as assessed with OCT (central retinal thickness, morphologic changes, fundus photos)	after one year compared to baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of retreatments	after one year

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 18, 2016
• First Submitted That Met QC Criteria: January 27, 2016
• First Posted (Estimated): February 1, 2016

Study Record Updates

• Last Update Posted (Actual): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration; Macular Edema; Antineoplastic Agents; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: OPHTH-010915 (Ex-Oct)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO