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

Phase 4

Recruiting

• Conditions: Macular Edema; Retinal Neovascularization
• Interventions: Drug: Bevacizumab Injection [Avastin]

• Registration Number: NCT03211741
• Lead Sponsor: University Hospital, Ghent

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-22
• Study First Submitted: 2017-06-12
• Study First Submitted QC: 2017-07-05
• Study First Posted: 2017-07-07
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-08
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
open label	Bevacizumab Injection [Avastin]	-

Primary Outcome Measures

Name	Time	Method
Slit lamp examination	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
Fluorescein Angiography and Ocular Coherence Tomography	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.
Best Corrected Visual Acuity	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
Dilated Fundoscopy	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
Central Retinal Thickness	annually, up to ten years	central retinal thickness as measured with the ocular coherence tomography

Secondary Outcome Measures

Name	Time	Method
side-effects	annually, up to ten years

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Gent, Belgium