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Completed

NCT Number: NCT04524910

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)

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations

Multiple Locations, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Drug

As prescribed by the treating physician

Primary outcomes

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

    Time frame: Baseline to 6 months

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

Secondary outcomes

  1. Change in BCVA from baseline to 12 months

    Time frame: Baseline to 12 months

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

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

    Time frame: At baseline, 6 and 12 months

    Retinal and lesion characteristics were evaluated using spectral domain optical coherence tomography (OCT).

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

    Time frame: Baseline to 12 months

    TEAEs comprise both ocular and non-ocular TEAEs

  4. Severity of treatment-emergent adverse events

    Time frame: Baseline to 12 months

    TEAEs comprise both ocular and non-ocular TEAEs

  5. Time from diagnosis to first treatment

    Time frame: At 12 months

  6. Number of aflibercept treatments

    Time frame: At 12 months

  7. Number of clinic visits

    Time frame: At 12 months

  8. Number of visual acuity tests performed

    Time frame: At 12 months

  9. Number of imaging assessments performed

    Time frame: At 12 months

  10. Type of imaging assessments performed

    Time frame: At 12 months

    Imaging assessments as : OCT- Optical coherence tomography; OCTA- Optical coherence tomography angiography; FA- Fluorescein angiography and ICGA- Indocyanine green angiography

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A REtrospective Non-interventional Study to Assess the Effectiveness of AfLibercept in Patients With Myopic CNV

Acronym: REALM

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 24, 2020
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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