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The Impact of Baseline Visual Acuity on the Treatment Outcomes in Patients Treated With AflIbercept in Real-life Clinical Setting (INSIGHT)

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ClinicalTrials.gov Identifier: NCT03278262
Recruitment Status : Completed
First Posted : September 11, 2017
Last Update Posted : October 29, 2018
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Wet Macular Degeneration Drug: Aflibercept (Eylea, BAY86-5321)

Study Design
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Study Type : Observational
Actual Enrollment : 2312 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
>= 70 letters
Baseline VA >= 70 letters
 Drug: Aflibercept (Eylea, BAY86-5321)
Treatment-naïve eyes with neovascularization AMD (Age-related Macular Degeneration), with the indication to be treated with Aflibercept. One and/or two eyes per patient.
36-69 letters
Baseline VA 36-69 letters
 Drug: Aflibercept (Eylea, BAY86-5321)
Treatment-naïve eyes with neovascularization AMD (Age-related Macular Degeneration), with the indication to be treated with Aflibercept. One and/or two eyes per patient.
<=35 letters
Baseline VA <=35 letters
 Drug: Aflibercept (Eylea, BAY86-5321)
Treatment-naïve eyes with neovascularization AMD (Age-related Macular Degeneration), with the indication to be treated with Aflibercept. One and/or two eyes per patient.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Visual Acuity (VA) (Snellen) [ Time Frame: at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up ]
    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.

  2. Change in Early Treatment Diabetic Retinopathy Study (ETDRS) [ Time Frame: at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up ]
    Change Early Treatment Diabetic Retinopathy Study (ETDRS) in all eyes and stratified in the three groups by VA at baseline.

  3. Change in Lasbarhetsindex (LIX, Readability Index) [ Time Frame: at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up ]
    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 Sweden


Secondary Outcome Measures :
  1. 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 points [ Time Frame: At year 1 and year 2 ]
    Patients 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 points

  2. Proportion of patients that recuperate 20/20 vision (driving vision) in all patients and stratified by baseline VA (groups 1-3) [ Time Frame: Up to 2 years ]
    In all patients and stratified by baseline VA (groups 1-3)

  3. Proportion of patients that recuperate 20/40 vision (driving vision) in all patients and stratified by baseline VA (groups 1-3) [ Time Frame: Up to 2 years ]
    In all patients and stratified by baseline VA (groups 1-3)

  4. Proportion of patients with no need of Vision Aid support [ Time Frame: Up to 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients registered in the Swedish Macula Register during the study period.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278262


Locations
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Sweden
Many locations
Lund, Sweden
Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals
More Information
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Additional Information:

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03278262    
Other Study ID Numbers: 19473
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Aflibercept
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents