MedDataX Logo

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

NCT ID: NCT03211741

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-22

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retinal Neovascularization Macular Edema

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Bevacizumab

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

open label

Group Type OTHER

Bevacizumab Injection [Avastin]

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ghent University Hospital

Ghent, , Belgium

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Julie De Zaeytijd, MD

Role: CONTACT

Phone: +32 9 332 26 29

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Julie De Zaeytijd, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EudraCT number: 2013-005056-15

Identifier Type: -

Identifier Source: org_study_id