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200 eyes with each subtype of neovascular age-related macular degeneration will be included in this study and 3 years after the initial intravitreal bevacizumab, best-corrected visual acuity (BCVA) will be measured using Snellen charts at 6m. Central retinal thickness (CRT) will be measured using Stratus OCT and Cirrus SD-OCT (Zeiss). Data of treatment-naive eyes (group 1) were compared to the data of eyes that had undergone prior treatment with photodynamic therapy with verteporfin and intravitreal triamcinolone acetonide (group 2).
In this interventional clinical study, 181 eyes of 160 consecutive patients with active neovascular related macular degeneration meeting recommended criteria for inclusion and protocol criteria for anti-vascular endothelial growth factor therapy undergoing intravitreal bevacizumab monotherapy were evaluated. Data of treatment-naive eyes (Group 1, n = 114) were analyzed separately from eyes that had undergone previous photodynamic therapy plus intravitreal triamcinolone (Group 2, n = 67). Re-treatment criteria were based on clinical outcome following the official European label regimen. After 1 year of continuous service at an academic referral center, follow-up was performed in private practices in collaboration with the referral center. Main outcome parameters were best-corrected visual acuity and central retinal thickness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | Experimental | bevacizumab intravitreal injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | intraocular bevacizumab injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Vision | Best-corrected visual acuity converted to logMAR (MAR=minimum angle of resolution) for statistical analysis | 3 years after first intravitreal bevacizumab treatment |
| CRT (Central Retinal Thickness) | Central retinal thickness measured in µm | 3 years after initial intravitreal bevacizumab treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic Complications After Treatment | 3 years after initial bevacizumab treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Sacu, PD Dr. | Department of Ophthalmology, Medical University of Vienna, Austria | Principal Investigator |
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Inclusion criteria:
Exclusion criteria:
- patients with other macular diseases
Medical University of Vienna, Department of Ophthalmology during September 2008-July 2009 with a mean of 3 year follow-up after initial Bevacizumab intravitreal treatment
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | 3 year follow-up of patients with intravitreal application of bevacizumab: From August 2005 to July 2006: 1 mg (0.04 mL) of bevacizumab After July 2006: 2.5 mg (0.1 mL) of Bevacizumab Follow-up intervals: 6-8 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | 3 year follow-up of intravitreal application of bevacizumab |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Vision | Best-corrected visual acuity converted to logMAR (MAR=minimum angle of resolution) for statistical analysis | Posted | Mean | Standard Deviation | logMAR | 3 years after first intravitreal bevacizumab treatment |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | 3 year follow-up of intravitreal application of bevacizumab |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| intraocular inflammation | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assoc.Prof.PD.Dr.Stefan Sacu | Medical University of Vienna | +43404001 | 7937 | stefan.sacu@meduniwien.ac.at |
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| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D056965 | Injections, Intraocular |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | CRT (Central Retinal Thickness) | Central retinal thickness measured in µm | Posted | Mean | Standard Deviation | µm | 3 years after initial intravitreal bevacizumab treatment |
|
|
|
| Secondary | Systemic Complications After Treatment | Posted | Number | participants | 3 years after initial bevacizumab treatment |
|
|
|
| 5 |
| 160 |
| 0 |
| 160 |
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| D008679 |
| Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |