Aflibercept in Recurrent or Persistent CNV

NCT02669953 | Recruiting

• 1 other identifier: OPHTH-010915 (Ex-Oct)
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Age Related Macular Degeneration; Intravitreal Injections; Diabetic Macular Edema

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Number of retreatments

  after one year

Study Arms (4)

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

Interventions

Aflibercept DRUG

AMD patients previously teated with Lucentis; DME patients previously teated with Lucentis; treatment naive AMD patients; treatment naive DME patients

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

20 Patients with nAMD

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Central Study Contacts

Reinhard Told, MD, PhD

CONTACT

+43140400; reinhard.told@meduniwien.ac.at

Stefan Sacu, Prof. PD. MD

CONTACT

+43140400; stefan.sacu@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. PD. Dr.

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: February 1, 2016
• Study Start: December 1, 2015
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)