Trial Condition(s):
Wet Macular Degeneration
The impact of baseline visual acuity on the treatment outcomes in patients treated with AflIbercept in real-life clinical setting (INSIGHT)
Bayer Identifier:
19473
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The study will assess the mean change in Visual Acuity (VA) (overall and stratified by baseline VA) at year 1 and 2 of treatment with Aflibercept in real-life setting.
In addition, the study will ascertain the baseline VA in treatment –naïve Wet Age-Related Macular Degeneration or neo-vascular AMD (wAMD) patients who start treatment with Aflibercept in a real-life setting and it will assess the impact of baseline VA on the outcomes of Aflibercept treatment.
Inclusion Criteria
-Treatment-naïve eyes with neovascularization AMD, with the indication to be treated with Aflibercept. One and/or two eyes per patient.
Exclusion Criteria
-Eyes treated previously with another anti-VEGF drug.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many locations Lund, Sweden | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
INSIGHT – The Impact of baseliNe viSual acuity on the treatment outcomes in patients treated with AflIbercept in real-life clinical settinG. Analysis of data from the SwedisH Macula RegisTer
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
3
Primary Outcome
- Change in Visual Acuity (VA) (Snellen)Change in VA (Snellen) at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up in all eyes and stratified in the three groups by Visual Acuity (VA) at baseline.Timeframe: at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up
- Change in Early Treatment Diabetic Retinopathy Study (ETDRS)Change Early Treatment Diabetic Retinopathy Study (ETDRS) in all eyes and stratified in the three groups by VA at baseline.Timeframe: at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up
- Change in Lasbarhetsindex (LIX, Readability Index)Change in LIX in all eyes and stratified in the three groups by VA at baseline. LIX: Jaeger/LIX adult A chart (Ortho-KM, Lund, Sweden). The LIX-chart is a standardized readability index for measuring near vision and it is used almost ubiquitously in eye clinics in SwedenTimeframe: at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up
Secondary Outcome
- Proportion of patients with Gain of vision 5 to 15 letters; > 15 letters; Loss of vision >5 to <15 letters; >15 letters or Stable -5 to +5 letters at the annual time pointsPatients with Gain of vision 5-15 letters, > 15 letters; Loss of vision >5-<15 letters; >15 letters or Stable -5-+5 letters at the annual time pointsTimeframe: At year 1 and year 2
- Proportion of patients that recuperate 20/20 vision (driving vision) in all patients and stratified by baseline VA (groups 1-3)In all patients and stratified by baseline VA (groups 1-3)Timeframe: Up to 2 years
- Proportion of patients that recuperate 20/40 vision (driving vision) in all patients and stratified by baseline VA (groups 1-3)In all patients and stratified by baseline VA (groups 1-3)Timeframe: Up to 2 years
- Proportion of patients with no need of Vision Aid supportTimeframe: Up to 2 years
Additional Information
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