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Longterm Efficiency and Safety of Intravitreal Injections With Bevacizumab in Patients With Neovascularisation or Macular Edema
This study is currently recruiting participants.
Verified July 2017 by University Hospital, Ghent
Sponsor:
University Hospital, Ghent
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT03211741
First received: June 12, 2017
Last updated: July 5, 2017
Last verified: July 2017
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Retinal Neovascularization Macular Edema | Drug: Bevacizumab Injection [Avastin] | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment |
| Official Title: | Longterm Efficiency and Safety of Intravitreal Injections With Bevacizumab in Patients With Neovascularisation or Macular Edema |
Resource links provided by NLM:
Further study details as provided by University Hospital, Ghent:
Primary Outcome Measures:
- 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
- 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
- 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
- Central Retinal Thickness [ Time Frame: annually, up to ten years ]central retinal thickness as measured with the ocular coherence tomography
- 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:
- side-effects [ Time Frame: annually, up to ten years ]
| Estimated Enrollment: | 350 |
| Actual Study Start Date: | November 22, 2013 |
| Estimated Study Completion Date: | January 1, 2019 |
| Estimated Primary Completion Date: | January 1, 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211741
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211741
Contacts
| Contact: Julie De Zaeytijd, MD | +32 9 332 26 29 | julie.dezaeytijd@ugent.be |
Locations
| Belgium | |
| Ghent University Hospital | Recruiting |
| Gent, Belgium, 9000 | |
| Contact: Julie De Zaeytijd, MD +3293322629 julie.dezaeytijd@ugent.be | |
Sponsors and Collaborators
University Hospital, Ghent
More Information
| Responsible Party: | University Hospital, Ghent |
| ClinicalTrials.gov Identifier: | NCT03211741 History of Changes |
| Other Study ID Numbers: |
EudraCT number: 2013-005056-15 |
| Study First Received: | June 12, 2017 |
| Last Updated: | July 5, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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:
|
Edema Macular Edema Neovascularization, Pathologic Retinal Neovascularization Signs and Symptoms Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |
Metaplasia Pathologic Processes Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on July 11, 2017