Skip to main content
OpenTrials
Completed

NCT Number: NCT03211741

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Retinal Neovascularization Eye Diseases Macular Degeneration Macular Edema Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)
  • 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
  • History of hypersensitivity for bevacizumab.

Treatment and study plan

Bevacizumab Injection [Avastin]

Drug

Bevacizumab 1.25mg/0.05 mL will be injected intravitreally using one 30-gauge x 1/2-inch injection needle vials are for single eye use only.

Primary outcomes

  1. Best Corrected Visual Acuity

    Time frame: every visit, up to ten years

    will be performed with a 1, 3 or 6 month interval (or more frequent) as long as there are signs of disease activity

  2. Slit lamp examination

    Time frame: every visit, up to ten years

    will be performed with a 1, 3 or 6 month interval (or more frequent) as long as there are signs of disease activity

  3. Dilated Fundoscopy

    Time frame: every visit, up to ten years

    will be performed with a 1, 3 or 6 month interval (or more frequent) as long as there are signs of disease activity

  4. Central Retinal Thickness

    Time frame: annually, up to ten years

    central retinal thickness as measured with the ocular coherence tomography

  5. Fluorescein Angiography and Ocular Coherence Tomography

    Time frame: annually, up to ten years

    fluorescein angiography and ocular coherence tomography. The necessity of these investigations is determined by the degree of activity and as deemed necessary by the investigator.

Secondary outcomes

  1. side-effects

    Time frame: annually, up to ten years

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Acronym: 2013-005056-15

Important dates

Study start
2013
Primary completion
2024
Study completion
2024
First posted
Jul 7, 2017
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.