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NCT05850520 · ClinicalTrials.gov registry record · Phase 3
A Study to Learn How Well a Higher Amount of Aflibercept Given as an Injection Into the Eye Works and How Safe it is in People With Reduced Vision Due to Swelling in the Macula, Central Part of the Retina Caused by a Blocked Vein in the Retina (Macula Edema Secondary to Retinal Vein Occlusion)
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 892
- Enrollment target
NCT05850520 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 892 participants.
The verdict
NCT05850520, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 892 participants
- Enrollment target
Study Summary
Researchers are looking for a better way to treat people who have macular edema secondary to retinal vein occlusion (RVO). In people with RVO, a blood vessel that carries blood away from the retina (vein) becomes blocked. The retina is the very back part of the eye. The blocked vein causes fluid and blood to leak into the retina and thereby causes a swelling of the macula (the center of the retina responsible for fine vision). This swelling is called macular edema. When a vein in the retina is blocked, the levels of a protein called vascular endothelial growth factor (VEGF) rises. VEGF helps the growth of new blood vessels. This can lead to macular edema and may cause the vision to become blurry. The study treatment intravitreal (IVT) aflibercept is given as an injection into the eye. It works by blocking VEGF and this can help repair vision problems related to RVO. IVT aflibercept is already available and is prescribed by doctors as the standard of care treatment for macula edema secondary to RVO. Standard of care is a treatment that medical experts consider most appropriate for a disease. Standard of care is given every 4 weeks in people with macula edema secondary to RVO. While repeated injections of aflibercept may prevent worsening of vision, it may place a burden on the patient. However, a higher amount (8 mg) compared to the standard of care (2 mg) of IVT aflibercept is being tested in studies. This higher amount could be given less often. The amount of IVT aflibercept given is measured in milligrams, also known as mg. The main purpose of this study is to learn how well a higher amount of the study treatment aflibercept works in people with macular edema secondary to RVO. To answer this, researchers will measure changes in vision called best corrected visual acuity (BCVA) in the study participants between study start and after 36 weeks of treatment. Changes will then be compared between those participants who received the higher amount of IVT aflibercept
Interventions
- DRUG Sham
- DRUG Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose
- DRUG Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_2 mg
- DIAGNOSTIC_TEST Fluorescein
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 892 participants |
| Start Date | 2023-05-15 |
| Est. Completion | 2025-05-27 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05850520
The ClinicalTrials.gov registry entry for NCT05850520 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 892 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Sham is the first listed.
NCT05850520 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05850520 about?
NCT05850520 is a clinical study titled "A Study to Learn How Well a Higher Amount of Aflibercept Given as an Injection Into the Eye Works and How Safe it is in People With Reduced Vision Due to Swelling in the Macula, Central Part of the Retina Caused by a Blocked Vein in the Retina (Macula Edema Secondary to Retinal Vein Occlusion)". Researchers are looking for a better way to treat people who have macular edema secondary to retinal vein occlusion (RVO). In people with RVO, a blood vessel that carries blood away from the retina (vein) becomes blocked. The retina is the very back part of the eye. The blocked vein causes fluid an...
What is the current status of trial NCT05850520?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 892 participants. The study started on 2023-05-15. Estimated completion is 2025-05-27.
What interventions are being tested in trial NCT05850520?
The interventions under investigation include: Sham (DRUG), Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose (DRUG), Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_2 mg (DRUG), Fluorescein (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05850520?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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