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)
- Sponsor
- Bayer
- Study ID
- NCT04524910
- Status
- Completed
Conditions
- Myopic Choroidal Neovascularization
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) — DRUGAs prescribed by the treating physician
Study Details
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 Dates
- Start date
- Jun 16, 2021
- Status verified
- Jun 2023
- Primary completion
- Oct 17, 2022
- Completion
- Nov 11, 2022
Study Design
- Enrollment
- 28 participants (actual)
Arms
- Arm: mCNV patientsAdult Canadian patients diagnosed with myopic choroidal neovascularization (mCNV) and naïve for anti-VEGF treatment
Primary Outcome Measure
Change in best corrected visual acuity (BCVA) from baseline to 6 months [ Time Frame: Baseline to 6 months ]