Aflibercept in Recurrent or Persistent CNV

Recruiting

• Conditions: Intravitreal Injections; Age Related Macular Degeneration; Diabetic Macular Edema
• Interventions: Drug: Aflibercept

• Registration Number: NCT02669953
• Lead Sponsor: Medical University of Vienna

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-01-18
• Study First Submitted QC: 2016-01-27
• Study First Posted: 2016-02-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26
• Primary Completion: 2025-11
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AMD patients previously teated with Lucentis	Aflibercept	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.
treatment naive AMD patients	Aflibercept	Adults ≥ 50 years; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS;
DME patients previously teated with Lucentis	Aflibercept	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;
treatment naive DME patients	Aflibercept	Adults ≥ 50 years; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS;

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of retreatments	after one year

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria