Fact CheckerSign in

NCT03211741CompletedPhase 4

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

Source: ClinicalTrials.gov · Last updated 21 Sept 2026

Brief summary (registry, in English)

Although the safety and efficacy of bevacizumab has been established in several phase 3 trials, there is only little documented about the long-term safety and efficacy in the 'real-world practice' in large populations from different regions. Therefore the investigators evaluate the long-term safety and efficacy of intravitreal treatment with bevacizumab by registration of best corrected visual acuity, side-effects and central retinal thickness as measured with the ocular coherence tomography if available. This will allow the investigators to compare the results of their centre with the results of several phase 3 trials from the literature and will guide improvements in their treatment protocols.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
583 (actual)
First submitted
12 Jun 2017
Start date
22 Nov 2013
Primary completion date
9 Jul 2024
Lead sponsor
University Hospital, Ghent
NCT number
NCT03211741

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 583
  • From 22 Nov 2013 to the primary completion date, 9 Jul 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Tromboembolic event (CVA or transient ischemic attack, AMI) less than 3 months prior to the intravitreal injection of bevacizumab

Other illness

  • History of hypersensitivity for bevacizumab.

Lab values

  • 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)

Who the study is looking for

  • Age ≥ 18 years of either gender
  • Written informed consent must be obtained before any intravitreal injection of bevacizumab is performed
  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ghent university hospital
Coordinator of this site? Confirm its status
GhentBelgiumUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.