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

NCT03211741 | Unknown Phase 4

• 1 other identifier: EudraCT number: 2013-005056-15
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Neovascularization; Macular Edema

Keywords

Bevacizumab

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• side-effects

  annually, up to ten years

Study Arms (1)

open label

OTHER

Drug: Bevacizumab Injection [Avastin]

Interventions

Bevacizumab Injection [Avastin] 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.

open label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Retinal Neovascularization; Macular Edema

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Macular Degeneration; Retinal Degeneration

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Julie De Zaeytijd, MD

CONTACT

+32 9 332 26 29; julie.dezaeytijd@ugent.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: July 7, 2017
• Study Start: November 22, 2013
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)