check_circleStudy Completed

Myopic Choroidal Neovascularization

Bayer Identifier:

20196

ClinicalTrials.gov Identifier:

NCT04524910

EudraCT Number:

Not Available

EU CT Number:

Not Available
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)

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 Years
  • - 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.
  • - 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.

Trial summary

Enrollment Goal
28
Trial Dates
June 2021 - November 2022
Phase
Phase 4
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many LocationsMany Locations, Canada

Primary Outcome

  • 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.
    date_rangeTime Frame:
    Baseline to 6 months

Secondary Outcome

  • Change in BCVA from baseline to 12 months
    BCVA is assessed by ETDRS (Early Treatment Diabetic Retinopathy Study) or Snellen chart with conversion to ETDRS.
    date_rangeTime Frame:
    Baseline to 12 months
  • Central retinal thickness (in μm) measured by Optical coherence tomography (OCT)
    Retinal and lesion characteristics were evaluated using spectral domain optical coherence tomography (OCT).
    date_rangeTime Frame:
    At baseline, 6 and 12 months
  • Number of treatment-emergent adverse events (TEAS's)
    TEAEs comprise both ocular and non-ocular TEAEs
    date_rangeTime Frame:
    Baseline to 12 months
  • Severity of treatment-emergent adverse events
    TEAEs comprise both ocular and non-ocular TEAEs
    date_rangeTime Frame:
    Baseline to 12 months
  • Time from diagnosis to first treatment
    date_rangeTime Frame:
    At 12 months
  • Number of aflibercept treatments
    date_rangeTime Frame:
    At 12 months
  • Number of clinic visits
    date_rangeTime Frame:
    At 12 months
  • Number of visual acuity tests performed
    date_rangeTime Frame:
    At 12 months
  • Number of imaging assessments performed
    date_rangeTime Frame:
    At 12 months
  • Type of imaging assessments performed
    Imaging assessments as : OCT- Optical coherence tomography; OCTA- Optical coherence tomography angiography; FA- Fluorescein angiography and ICGA- Indocyanine green angiography
    date_rangeTime Frame:
    At 12 months

Trial design

A REtrospective non-interventional study to assess the effectiveness of AfLibercept in patients with Myopic CNV
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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