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NCT06591598: DEUTERON
A Study to Learn About the Blood Levels of Aflibercept When High-dose Aflibercept is Injected in Both Eyes of Participants With Diabetic Macular Edema or Neovascular Age-related Macular Degeneration
Phase 4 trial testing Aflibercept (BAY86-5321, Eylea) in Diabetic Macular Edema in 51 participants. Completed in 14 October 2025.
14 October 2025
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 51 |
| Start date | 2 September 2024 |
| Primary completion | 14 October 2025 |
| Estimated completion | 14 October 2025 |
| Sites | 6 locations across Slovakia, Hungary, Czechia |
Drugs / interventions tested
- Aflibercept (BAY86-5321, Eylea) — full drug profile →
Conditions studied
- Diabetic Macular Edema — all drugs for Diabetic Macular Edema →
- Neovascular Age-related Macular Degeneration — all drugs for Neovascular Age-related Macular Degeneration →
Sponsor
Bayer — full company profile →
Who can join
18 and older, any sex, with Diabetic Macular Edema or Neovascular Age-related Macular Degeneration. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Researchers are looking for a better way to treat participants who have diabetic macular edema (DME) or neovascular age-related macular degeneration (nAMD). DME is a diabetes-related eye disorder. In DME, the macula swells up due to fluid leakage from damaged blood vessels, resulting in vision problems. DME is a leading cause of vision loss in working age adults. nAMD is an eye disorder that causes vision loss due to the growth of abnormal blood vessels that leak blood or retinal fluid into the macula (the central part of the retina). nAMD is a leading cause of vision loss for people aged 50 and older. The study treatment Aflibercept (also called BAY 86-5321) is a drug that blocks a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth and leakage of blood vessels at the back of the eye. The main purpose of this study is to to collect more information on the blood levels of aflibercept when 8 mg aflibercept is injected in both eyes of participants with DME or nAMD. For this, the researchers will analyze Maximum observed concentration (Cmax): the highest amount of aflibercept in participants' blood will be measured after multiple doses of aflibercept during the study. Participants will receive 8 mg aflibercept as injections into the vitreous cavity (jelly-like substance that fills the centre of the eye) of both eyes. Participants will be divided into three groups and will receive initial and maintenance injections of 8 mg aflibercept in both eyes. Researchers will closely monitor the health of the participants during the study. During the study, the doctors and their study team will: * take blood and urine samples * do physical examinations * examine heart health using electrocardiogram (ECG) * check vital signs such as blood pressure, heart rate, body temperature * ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06591598
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other trials of Aflibercept (BAY86-5321, Eylea)
Trials testing the same drug.
- NCT04137120 — Study to Gather Information on the Safety and Use of Aflibercept Injections Into the Eye for the Treatment of Eye Disord · completed
Other recruiting trials for Diabetic Macular Edema
Currently open trials in the same condition.
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- NCT06984822 — Evaluation of Serum- and OCT Biomarkers in Patients With DME Treated With Anti-VEGF or Dexamethasone Implant · NA · recruiting
- NCT07038967 — Non-Center Involving Diabetic Macular Edema Progression in Early Postoperative Period After Phacoemulsification · recruiting
- NCT06680817 — A Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study) · recruiting
- NCT06549023 — Single Session vs Multiple-Session Panretinal Photocoagulation for Treatment of Proliferative Diabetic Retinopathy · NA · recruiting
Other Bayer trials
Trials by the same sponsor.
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- NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
- NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06591598 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bayer
- Last refreshed: 3 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06591598.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing