Collecting data on Eylea use in premature babies with eye blood vessel issues
Special Drug Use Investigation for Eylea for Retinopathy of Prematurity (ROP)
This study is collecting information on how well Eylea works for premature babies with eye blood vessel problems to help understand its effects on their condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | N/A to 2 Years |
| Sex | All |
| Sponsor | Bayer Industry-sponsored |
| Locations | 1 site (Multiple Locations) |
| Trial ID | NCT05705258 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather data on Japanese infants diagnosed with retinopathy of prematurity (ROP) who are treated with Eylea, an injection that blocks abnormal blood vessel growth in the retina. The study will monitor the outcomes of these treatments without implementing any specific interventions, focusing solely on the natural progression of the condition and the effects of Eylea. ROP is a serious condition that can lead to blindness if not treated appropriately, making this data collection crucial for understanding treatment efficacy in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are Japanese infants diagnosed with ROP who require treatment and have received Eylea injections.
Not a fit: Patients who do not have ROP or have received prior treatment for ROP before enrollment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of Eylea in treating ROP, potentially improving outcomes for premature infants.
How similar studies have performed: While observational studies on ROP exist, this specific approach using Eylea in a Japanese population is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of ROP requiring treatment * Patients who have received IVT-AFL treatment according to Japanese approved labeling for AFL in ROP. * ICF obtained from legal representative. Exclusion Criteria: * Patients who have contradictions based on approved label * Patients who have received IVT-AFL treatment before the treatment for the enrollment Patient. * Diagnosis of other indication
Where this trial is running
Multiple Locations
- Many locations — Multiple Locations, Japan (Recruiting)
Study contacts
- Study coordinator: Bayer Clinical Trials Contact
- Email: clinical-trials-contact@bayer.com
- Phone: (+)1-888-84 22937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.