Longterm Efficiency and Safety of Intravitreal Injections With Bevacizumab in Patients With Neovascularisation or Macular Edema

Launched by UNIVERSITY HOSPITAL, GHENT · Jul 5, 2017

Keywords

ClinConnect Summary

This clinical trial is studying the long-term safety and effectiveness of a treatment called bevacizumab, which is given as an injection into the eye. This treatment is aimed at helping people who have vision problems caused by abnormal blood vessel growth or swelling in the retina, a common issue in conditions like retinal neovascularization and macular edema. The researchers want to see how well this treatment works over time in real-world settings, beyond what has been shown in earlier studies.

To participate, individuals must be at least 18 years old and have vision impairment mainly due to the conditions being studied. They should also be able to provide written consent before starting treatment. If both eyes are affected, both can be included. However, women who are pregnant or breastfeeding, or those who have certain recent health issues, may not be eligible. Participants will have their vision and eye health monitored throughout the study, helping to improve future treatment approaches. If you or someone you know is interested in joining, it’s a good idea to talk to a healthcare provider for more details.

Gender

ALL

Eligibility 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.