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NCT03411941: REALE
Evaluate the Effectiveness of Intravitreal (IVT) Aflibercept Injection in Clinical Practice in naïve Patients With Neovascular Age-related Macular Degeneration (nAMD)
trial testing Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) in Macular Degeneration in 116 participants. Completed in 1 March 2019.
1 March 2019
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 116 |
| Start date | 28 February 2018 |
| Primary completion | 1 March 2019 |
| Estimated completion | 1 March 2019 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) — full drug profile →
Conditions studied
- Macular Degeneration — all drugs for Macular Degeneration →
Sponsor
Bayer — full company profile →
Who can join
50 and older, any sex, with Macular Degeneration. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
There is a need to investigate the effectiveness of IVT aflibercept injection in routine clinical practice. The aim of this study is to collect 12-month real-world clinical data from treatment-naïve nAMD patients who started first-line treatment with IVT aflibercept injection, according to the SmPC (Summary of Product Characteristics) and the SERV (Spanish Society of Retina and Vitreous) guidelines. The effectiveness of IVT aflibercept will be assessed by the changes in VA (Visual Acuity) and CRT (Central Retinal Thickness) during treatment.
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 NCT03411941
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Trials testing the same drug.
- NCT03521895 — An Integrated Analysis of the Effectiveness of Intravitreal (IVT) Aflibercept (Eylea) in Routine Clinical Practice Based · completed
- NCT03470103 — A Study in Patients With Wet Age-related Macular Degeneration or Diabetic Macular Edema to Assess the freQuency of Use o · completed
- NCT02850263 — A Study to Assess the Effectiveness of Aflibercept in Routine Clinical Practice in Patients With Diabetic Macular Oedema · completed
- NCT02585401 — Evaluation of Physician Knowledge of Safety and Safe Use Information for Aflibercept in Canada · completed
- NCT02581995 — Investigation of the Change of Vision-related Quality of Life in Subjects Treated With Aflibercept According to EU Label · Phase 4 · completed
Other recruiting trials for Macular Degeneration
Currently open trials in the same condition.
- NCT07440225 — A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002) · Phase 2, PHASE3 · recruiting
- NCT07085533 — Natural History Study of Inherited Retinal Diseases · recruiting
- NCT06805474 — A Prospective Observational Study to Assess the Reliability and Validity of the MLSDT · recruiting
- NCT06779773 — A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy · recruiting
- NCT06635148 — A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Se · Phase 2 · recruiting
Other Bayer trials
Trials by the same sponsor.
- NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
- NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
- NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
- 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 NCT03411941 (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: 5 December 2019
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/NCT03411941.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing