Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03211741
Recruitment Status : Unknown
Verified July 2017 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : July 7, 2017
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Retinal Neovascularization Macular Edema Drug: Bevacizumab Injection [Avastin] Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Longterm Efficiency and Safety of Intravitreal Injections With Bevacizumab in Patients With Neovascularisation or Macular Edema
Actual Study Start Date : November 22, 2013
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Bevacizumab

Arm Intervention/treatment
open label 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.




Primary Outcome Measures :
  1. Best Corrected Visual Acuity [ Time Frame: 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

  2. Slit lamp examination [ Time Frame: 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

  3. Dilated Fundoscopy [ Time Frame: 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

  4. Central Retinal Thickness [ Time Frame: annually, up to ten years ]
    central retinal thickness as measured with the ocular coherence tomography

  5. Fluorescein Angiography and Ocular Coherence Tomography [ Time Frame: 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.


Secondary Outcome Measures :
  1. side-effects [ Time Frame: annually, up to ten years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211741


Contacts
Layout table for location contacts
Contact: Julie De Zaeytijd, MD +32 9 332 26 29 julie.dezaeytijd@ugent.be

Locations
Layout table for location information
Belgium
Ghent University Hospital Recruiting
Gent, Belgium, 9000
Contact: Julie De Zaeytijd, MD    +3293322629    julie.dezaeytijd@ugent.be   
Sponsors and Collaborators
University Hospital, Ghent

Layout table for additonal information
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT03211741    
Other Study ID Numbers: EudraCT number: 2013-005056-15
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Ghent:
Bevacizumab
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Edema
Retinal Neovascularization
Edema
Neovascularization, Pathologic
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors