Retinal Neovascularization, Macular Edema
Conditions
Keywords
Bevacizumab
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.
Interventions
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.
Sponsors
University Hospital, Ghent
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best Corrected Visual Acuity | 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 | 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 | 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 | annually, up to ten years | central retinal thickness as measured with the ocular coherence tomography |
| Fluorescein Angiography and Ocular Coherence Tomography | 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
| Measure | Time frame |
|---|---|
| side-effects | annually, up to ten years |
Countries
Belgium
Contacts
Primary ContactJulie De Zaeytijd, MD
Outcome results
None listed