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

Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03211741
• Other study ID #: EudraCT number: 2013-005056-15
• Status: Recruiting
• Phase: Phase 4
• Start date: November 22, 2013
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: University Hospital, Ghent
• Contact: Julie De Zaeytijd, MD
• Phone: +32 9 332 26 29
• Email: julie.dezaeytijd[@]ugent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Neovascularization, Pathologic
• Retinal Neovascularization

Intervention

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.

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Gent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Central Retinal Thickness	central retinal thickness as measured with the ocular coherence tomography	annually, up to ten years
Primary	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	side-effects		annually, up to ten years