A Study to Learn More About How Drug Aflibercept Works in Canadian Patients With Reduced Vision Caused by New Blood Vessels Growing in the Eye (Myopic Choroidal Neovascularization or mCNV)

NCT04524910 | Completed

• 1 other identifier: 20196
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Being short sighted means that vision is blurry when looking at things far away. People with a condition called "pathologic myopia" are short sighted due to problems in the back layer of their eyes, also known as the retina. Some people with pathologic myopia can develop a serious condition called myopic choroidal neovascularization (mCNV). In people with mCNV, new blood vessels grow into the retina. These blood vessels can break, leaking blood or fluid into the retina. This can cause blurry vision or a loss of vision. In this study, researchers will find out more about how well drug aflibercept works and how safe it is in Canadian patients with mCNV. The researchers in this study will review information from the patients' eye doctor visits. The patients in this study will include Canadian men and women who started receiving aflibercept between May 2017 and August 2019. These patients were at least 18 years old and had not received treatment for their mCNV before. The researchers will look at the results of vision tests to find out how well the patients could read from a distance after they received aflibercept for 6 months. They will compare the results of these tests to before the patients received treatment. They will also learn more about how safe it is to have aflibercept injection into the eye.

Conditions

Myopic Choroidal Neovascularization

Keywords

Intravitreal Aflibercept; Choroidal Neovascularization; Vascular Endothelial Growth Factor (VEGF)

Outcome Measures

Primary Outcomes (1)

• Change in best corrected visual acuity (BCVA) from baseline to 6 months

  BCVA is assessed by ETDRS (Early Treatment Diabetic Retinopathy Study) or Snellen chart with conversion to ETDRS.

  Baseline to 6 months

Secondary Outcomes (10)

• Change in BCVA from baseline to 12 months

  Baseline to 12 months

• Central retinal thickness (in μm) measured by Optical coherence tomography (OCT)

  At baseline, 6 and 12 months

• Number of treatment-emergent adverse events (TEAS's)

  Baseline to 12 months

• Severity of treatment-emergent adverse events

  Baseline to 12 months

• Time from diagnosis to first treatment

  At 12 months

Study Arms (1)

mCNV patients

Adult Canadian patients diagnosed with myopic choroidal neovascularization (mCNV) and naïve for anti-VEGF treatment

Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Interventions

Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) DRUG

As prescribed by the treating physician

mCNV patients

Eligibility Criteria

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

Study Population

Patients to be enrolled into the study must have been diagnosed with mCNV and started anti-VEGF treatment with aflibercept.

You may qualify if:

• Adult (Age ≥ 18 years) female or male patient.
• Anti-VEGF treatment naïve patients diagnosed with mCNV.
• Initiation of treatment with aflibercept was made as per investigator's routine treatment practice between 01 MAY 2017 and 31 AUG 2019.

You may not qualify if:

• Any participation in an investigational program with interventions outside of routine clinical practice.
• Patients who have previously been treated with anti-VEGF intravitreal injections, systemic anti-VEGF or pro-VEGF treatments, as well as other intravitreal steroids or steroid implants for the study eye.
• Patients with another retinal disease (e.g. wet age-related macular degeneration,-wAMD; diabetic macular edema-DME; retinal vein occlusion-RVO), patients with advanced cataracts or glaucoma, or patients with scarring, fibrosis, or atrophy involving the center of the fovea.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many Locations

Multiple Locations, Canada

Location

Related Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

MeSH Terms

Conditions

Choroidal Neovascularization

Interventions

aflibercept

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 24, 2020
• Study Start: June 16, 2021
• Primary Completion: October 17, 2022
• Study Completion: November 11, 2022
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)