Retinal NeovascularizationPhase 42013-005056-15NCT03211741
Longterm Efficiency and Safety of Intravitreal Injections With Bevacizumab in Patients With Neovascularisation or Macular Edema
A Phase 4 study testing Bevacizumab Injection [Avastin] in people with Retinal Neovascularization and Macular Edema, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Neovascularization, Macular Edema
- What is being tested?
- Bevacizumab Injection [Avastin]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 583 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Nov 2013to 9 Jul 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Bevacizumab Injection [Avastin]
- Keywords
- Bevacizumab
- Medical subject headings
- Retinal Neovascularization, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| open label | Other | Not described Receives: Drug: Bevacizumab Injection [Avastin] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: every visit, up to ten years
Central Retinal Thickness
central retinal thickness as measured with the ocular coherence tomography
Measured: 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.
Measured: annually, up to ten years
Secondary outcomes (1)
side-effects
Measured: annually, up to ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start22 Nov 2013
- Primary completion9 Jul 2024
- Study completion9 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal NeovascularizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 583 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211741
- Sponsor's protocol ID
- BC-00584
- Acronym
- 2013-005056-15
- Status last verified
- Sep 2026
- First submitted
- 12 Jun 2017
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longterm Efficiency and Safety of Intravitreal Injections With Bevacizumab in Patients With Neovascularisation or Macular Edema
- ClinicalTrials.gov ID
- NCT03211741
- Acronym / sponsor ID
- 2013-005056-15 / BC-00584
- Conditions
- Retinal Neovascularization, Macular Edema
- Keywords
- Bevacizumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 583 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 22 Nov 2013 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open label | Other | Drug: Bevacizumab Injection [Avastin] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | open label |
Primary outcome
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.
1 secondary outcome
side-effects
Time frame: annually, up to ten years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bevacizumab Injection [Avastin] in people with Retinal Neovascularization and Macular Edema, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual Acuity (time frame: every visit, up to ten years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.