Long-term effects of Bevacizumab injections for eye conditions
Longterm Efficiency and Safety of Intravitreal Injections With Bevacizumab in Patients With Neovascularisation or Macular Edema
This study is testing how safe and effective Bevacizumab eye injections are for people with certain eye conditions over a long period of time.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Drugs / interventions | bevacizumab |
| Locations | 1 site (Gent) |
| Trial ID | NCT03211741 on ClinicalTrials.gov |
What this trial studies
This study evaluates the long-term safety and efficacy of intravitreal injections of Bevacizumab in patients suffering from retinal neovascularization and macular edema. By monitoring best corrected visual acuity, side effects, and central retinal thickness through ocular coherence tomography, the researchers aim to gather real-world data that can be compared with previous phase 3 trials. This approach will help refine treatment protocols based on the outcomes observed in a diverse patient population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with visual impairment due to abnormal new vessel growth or macular edema.
Not a fit: Patients who are pregnant, breastfeeding, or have had recent thromboembolic events may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term management of retinal conditions, potentially improving patient outcomes.
How similar studies have performed: Previous studies have established the safety and efficacy of Bevacizumab, but this study aims to provide new insights into its long-term effects in a real-world setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years of either gender 2. Written informed consent must be obtained before any intravitreal injection of bevacizumab is performed 3. Visual impairment predominantly due to abnormal new vessel ingrowth and/or macular edema. The presence of fluid (intraretinal, subretinal or sub-RPE) detected clinically or on the ocular coherence tomography. If both eyes are eligible for the study, both eyes can be included in the study. Exclusion Criteria: 1. Women who are pregnant or breastfeeding (pregnancy defined as the state of a female after conception until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory test (\> 5mIU/mL) 2. Women of child bearing potential must be practicing effective contraception implemented during the trial and for at least 28 days following the last dose of study medication 3. Tromboembolic event (CVA or transient ischemic attack, AMI) less than 3 months prior to the intravitreal injection of bevacizumab 4. History of hypersensitivity for bevacizumab.
Where this trial is running
Gent
- Ghent University Hospital — Gent, Belgium (Recruiting)
Study contacts
- Study coordinator: Julie De Zaeytijd, MD
- Email: julie.dezaeytijd@ugent.be
- Phone: +32 9 332 26 29
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.