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

Primary Purpose

Retinal Neovascularization, Macular Edema

Status

Recruiting

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

Bevacizumab Injection [Avastin]

About this trial

This is an interventional treatment trial for Retinal Neovascularization focused on measuring Bevacizumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Ghent University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

open label

Arm Description

Outcomes

Primary Outcome Measures

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

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

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

Central Retinal Thickness

central retinal thickness as measured with the ocular coherence tomography

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.

Secondary Outcome Measures

side-effects

Full Information

NCT ID

NCT03211741

First Posted

June 12, 2017

Last Updated

December 6, 2022

Sponsor

University Hospital, Ghent

1. Study Identification

Unique Protocol Identification Number

NCT03211741

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 22, 2013 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinal Neovascularization, Macular Edema

Keywords

Bevacizumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

open label

Arm Type

Other

Intervention Type

Drug

Intervention Name(s)

Bevacizumab Injection [Avastin]

Intervention Description

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 Outcome Measure Information:

Title

Best Corrected Visual Acuity

Description

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

Time Frame

every visit, up to ten years

Title

Slit lamp examination

Description

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

Time Frame

every visit, up to ten years

Title

Dilated Fundoscopy

Description

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

Time Frame

every visit, up to ten years

Title

Central Retinal Thickness

Description

central retinal thickness as measured with the ocular coherence tomography

Time Frame

annually, up to ten years

Title

Fluorescein Angiography and Ocular Coherence Tomography

Description

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.

Time Frame

annually, up to ten years

Secondary Outcome Measure Information:

Title

side-effects

Time Frame

annually, up to ten years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Julie De Zaeytijd, MD

Phone

+32 9 332 26 29

julie.dezaeytijd@ugent.be

Facility Information:

Facility Name

Ghent University Hospital

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Julie De Zaeytijd, MD

Phone

+3293322629

julie.dezaeytijd@ugent.be

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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