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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open label | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| side-effects | annually, up to ten years |
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Inclusion Criteria:
If both eyes are eligible for the study, both eyes can be included in the study.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie De Zaeytijd, MD | Contact | +32 9 332 26 29 | julie.dezaeytijd@ugent.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Recruiting | Ghent | 9000 | Belgium |
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| ID | Term |
|---|---|
| D015861 | Retinal Neovascularization |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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