Trial Condition(s):

Myopic Choroidal Neovascularization

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) (REALM)

Bayer Identifier:

20196

ClinicalTrials.gov Identifier:

NCT04524910

EudraCT Number:

Not Available

Study Completed

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.

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.

Trial Summary

Enrollment Goal
28
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many Locations

Many Locations, Canada

Status
Completed
 

Trial Design