Neovascular Age-related Macular Degeneration
Conditions
Keywords
bevacizumab, choroidal neovascularization
Brief summary
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).
Detailed description
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.
Interventions
DRUGBevacizumab
intraocular bevacizumab injection
Sponsors
Medical University of Vienna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* any subtype of neovascular age-related macular degeneration * age of 50 years or older * initial treatment with intravitreal bevacizumab between August 2005 and June 2006
Exclusion criteria
* previous vitrectomy * presence of cystoid macular edema without choroidal neovascularization * Uncontrolled systemic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vision | 3 years after first intravitreal bevacizumab treatment | Best-corrected visual acuity converted to logMAR (MAR=minimum angle of resolution) for statistical analysis |
| CRT (Central Retinal Thickness) | 3 years after initial intravitreal bevacizumab treatment | Central retinal thickness measured in µm |
Secondary
| Measure | Time frame |
|---|---|
| Systemic Complications After Treatment | 3 years after initial bevacizumab treatment |
Participant flow
Recruitment details
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
Pre-assignment details
Inclusion criteria: * patients treated with bevacizumab due to wet age-related macular degeneration * follow-up of 3 years Exclusion criteria: \- patients with other macular diseases
Participants by arm
| Arm | Count |
|---|---|
| Group 1 3 year follow-up of intravitreal application of bevacizumab | 160 |
| Total | 160 |
Baseline characteristics
| Characteristic | Group 1 |
|---|---|
| Age, Customized | 77.24 years STANDARD_DEVIATION 10.56 |
| Sex: Female, Male Female | 102 Participants |
| Sex: Female, Male Male | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 160 |
| serious Total, serious adverse events | 5 / 160 |
Outcome results
Primary
CRT (Central Retinal Thickness)
Central retinal thickness measured in µm
Time frame: 3 years after initial intravitreal bevacizumab treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | CRT (Central Retinal Thickness) | 319 µm | Standard Deviation 110 |
Primary
Vision
Best-corrected visual acuity converted to logMAR (MAR=minimum angle of resolution) for statistical analysis
Time frame: 3 years after first intravitreal bevacizumab treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Vision | 0.16 logMAR | Standard Deviation 0.21 |
Secondary
Systemic Complications After Treatment
Time frame: 3 years after initial bevacizumab treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 | Systemic Complications After Treatment | Retinal Detachment | 0 participants |
| Group 1 | Systemic Complications After Treatment | Endophthalmitis | 0 participants |
| Group 1 | Systemic Complications After Treatment | Severe intraocular inflammation | 5 participants |
| Group 1 | Systemic Complications After Treatment | thromboembolic disease with myocardial infarction | 0 participants |