Prospective Observational Study to Assess Effectiveness of Intravitreal Aflibercept in Patients With Wet Macular Degeneration in Greece

NCT02821247 | Completed DMC FDA Drug

• 2 other identifiers: 18033SIRIUS/OS-CY-1668
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, observational, multi-center, study. The study will be conducted in approximately 12 ophthalmological clinics and practices throughout Greece. It is planned to collect data on treatment of wet Age related Macular Degeneration (wAMD) from about 120 patients for which the decision to treat with intravitreal aflibercept injections is made at the discretion of the attending physician, according to his/her medical practice. Visits will be performed at baseline, aflibercept first injection (if different from enrollment) and at 12 and 24 months. The 12 and 24 month comprise the data collection visits during which any data generated in the period preceding these visits will be recorded. All required information for the purposes of this study will be collected using electronic Case Record Form (eCRF). The web-based electronic data capture (EDC) application will be specifically designed for the needs of the study and will adhere to all applicable data protection regulations and requirements with regard to electronic records. The study observation period for each patient enrolled in this study is the time from the beginning of treatment with intravitreal aflibercept injection up to two years or until discontinuation of intravitreal aflibercept injection-treatment due to any reason including withdrawal of consent or patient loss from follow-up.

Conditions

Choroidal Neovascularization; Macular Degeneration

Keywords

Treatment Naïve Patients

Outcome Measures

Primary Outcomes (1)

• Mean change of visual acuity from baseline to 12 months

  At baseline and 12 months

Secondary Outcomes (12)

• Change in best corrected visual acuity (BCVA) (with manifest refraction) from baseline at the 24-month timepoint

  At baseline, At 24 months

• Change in visual acuity with glasses from baseline to the 24-month timepoint

  At baseline, At 24 months

• Change in central retinal thickness (OCT measurement) at 12 and 24 months

  At 12 months, At 24 months

• Proportion of patients with no fluid at, 12 and 24 months

  At 12 months, At 24 months

• Total number of routine clinical evaluation (monitoring) visits at 12 and 24 months

  At 12 months, At 24 months

Study Arms (1)

Aflibercept

Adult wet Age Related Macular degeneration (AMD) treatment naïve partcipants were treated with intravitreal aflibercept injection

Drug: Aflibercept (Eylea, BAY86-5321)

Interventions

Aflibercept (Eylea, BAY86-5321) DRUG

Intravitreal injection; should comply with the recommendations written in the local Summary of Product Characteristics (SPC) of the product

Also known as: VEGF Trap-Eye

Aflibercept

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consisted of patients treated with Aphlibercept as first treatment for wAMD ( Treatment Naïve Patients).

You may qualify if:

• Treatment naive patients with wet AMD for whom the decision to be treated with intravitreal aflibercept injection in accordance with the Summary of Product Characteristics was made.
• Patients having signed the informed consent.

You may not qualify if:

• Contraindications as listed in the local Summary of Product Characteristics.
• Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
• Any prior or concomitant therapy with any other agent (including among others, anti-VEGF agents and photodynamic therapy) to treat wet AMD in the study eye.
• Patients with previous exposure to systemic anti-VEGF treatment.
• Patients participating in an investigational program with interventions.
• Previous macular surgery, including laser, for any retinal pathology in the study eye.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many Locations

Multiple Locations, Greece

Location

Related Links

• Click here to find results for studies related to Bayer products

MeSH Terms

Conditions

Choroidal Neovascularization; Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Retinal Degeneration; Retinal Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: July 1, 2016
• Study Start: July 1, 2016
• Primary Completion: July 10, 2019
• Study Completion: December 13, 2019
• Last Updated: November 25, 2020

Record last verified: 2020-11

Locations

GR (1)