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)

• ClinicalTrials.gov Identifier: NCT04524910
• Recruitment Status: Active, not recruiting
• First Posted: August 24, 2020
• Last Update Posted: February 24, 2022
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

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.

Condition or disease	Intervention/treatment
Myopic Choroidal Neovascularization	Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Study Design

• Study Type: Observational
• Actual Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: A REtrospective Non-interventional Study to Assess the Effectiveness of AfLibercept in Patients With Myopic CNV
• Actual Study Start Date: June 16, 2021
• Estimated Primary Completion Date: March 31, 2022
• Estimated Study Completion Date: March 31, 2022

Groups and Cohorts

Group/Cohort	Intervention/treatment
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); As prescribed by the treating physician

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

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.

Contacts and Locations

Locations

Canada

Many Locations

Multiple Locations, Canada

Sponsors and Collaborators

Bayer

More Information

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT04524910
• Other Study ID Numbers: 20196
• First Posted: August 24, 2020
• Last Update Posted: February 24, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:

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

Additional relevant MeSH terms:

Choroidal Neovascularization; Myopia; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Choroid Diseases; Uveal Diseases; Eye Diseases; Refractive Errors; Aflibercept; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Antineoplastic Agents