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.

Study Overview

• Status: Recruiting
• Conditions: Macular Edema; Retinal Neovascularization
• Intervention / Treatment: Drug: Bevacizumab Injection [Avastin]

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Julie De Zaeytijd, MD; Phone Number: +32 9 332 26 29; Email: julie.dezaeytijd@ugent.be

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • Recruiting
    • Ghent University Hospital
    • Contact: Julie De Zaeytijd, MD; Phone Number: +3293322629; Email: julie.dezaeytijd@ugent.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: open label	Drug: Bevacizumab Injection [Avastin]; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best Corrected Visual Acuity	will be performed with a 1, 3 or 6 month interval (or more frequent) as long as there are signs of disease activity	every visit, up to ten years
Slit lamp examination	will be performed with a 1, 3 or 6 month interval (or more frequent) as long as there are signs of disease activity	every visit, up to ten years
Dilated Fundoscopy	will be performed with a 1, 3 or 6 month interval (or more frequent) as long as there are signs of disease activity	every visit, up to ten years
Central Retinal Thickness	central retinal thickness as measured with the ocular coherence tomography	annually, up to ten years
Fluorescein Angiography and Ocular Coherence Tomography	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.	annually, up to ten years

Secondary Outcome Measures

Outcome Measure	Time Frame
side-effects	annually, up to ten years

Collaborators and Investigators

• Sponsor: University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2013
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 12, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (Actual): July 7, 2017

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Bevacizumab
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Metaplasia; Macular Edema; Neovascularization, Pathologic; Edema; Retinal Neovascularization; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: EudraCT number: 2013-005056-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No