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| ID | Type | Description | Link |
|---|---|---|---|
| NN1101 | Other Identifier | company internal |
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Retrospective, non-interventional, observational multi-center field study. Patients diagnosed with wet Age-related macular degeneration (wAMD) and having started treatment with ranibizumab between January 1, 2009 and August 31, 2009 must be consecutively screened and, if eligible, enrolled. Patients will be followed up at maximum until August 31, 2011. Switch to any other Anti vascUlar endothelial growth factor (anti VEGF) treatment will be documented and followed up. For each patient, demographics, medical history, administered treatments, results of ocular and visual assessments and other tests (where available) will be documented.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | Patients with wet AMD treated with ranibizumab as prescribed by physician |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in visual acuity after start of Anti vascUlar endothelial growth factor (anti VEGF) therapy with ranibizumab, assessed by Early Treatment Diabetic Retinopathy (ETDRS) or Snellen chard | Baseline and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic characteristics of patients included in the study (Age, Sex, Race) | Baseline | |
| Mean time from first clinical presentation to diagnosis | Time from first clinical presentation to diagnosis: Up to 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients must have been diagnosed to suffer from wet AMD and must have started anti-VEGF treatment with ranibizumab between January 1, 2009, and August 31, 2009.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Australia | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27030279 | Derived | Holz FG, Tadayoni R, Beatty S, Berger A, Cereda MG, Hykin P, Staurenghi G, Wittrup-Jensen K, Altemark A, Nilsson J, Kim K, Sivaprasad S. Key drivers of visual acuity gains in neovascular age-related macular degeneration in real life: findings from the AURA study. Br J Ophthalmol. 2016 Dec;100(12):1623-1628. doi: 10.1136/bjophthalmol-2015-308166. Epub 2016 Mar 30. | |
| 25193672 |
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| Mean time from diagnosis to treatment | Time from diagnosis to treatment: Up to 24 months |
| Mean time from diagnosis to end of follow-up | Time from diagnosis to end of follow-up: 48 months |
| Mean change of visual acuity, from diagnosis to end of follow-up, assessed by Early Treatment Diabetic Retinopathy (ETDRS) or SNELLEN | Baseline and 24 months |
| Mean change of retinal thickness from diagnosis to end of follow-up, assessed by Optical Coherence Tomography (OCT) | Baseline and 24 months |
| Mean change of lesion size from diagnosis to end of follow-up, assessed by Fluorescein Angiography (FA) | Baseline and 24 months |
| Average number of treatments given from diagnosis to end of follow-up | After 24 months |
| Vital Signs (blood pressure, heart rate, temperature) of patients included in the study | Baseline |
| Medical and surgical history (diseases and surgeries) of patients included in the study | Baseline |
| Many Locations |
| Canada |
| Many Locations | France |
| Many Locations | Germany |
| Many Locations | Ireland |
| Many Locations | Italy |
| Many Locations | Japan |
| Many Locations | Netherlands |
| Many Locations | United Kingdom |
| Many Locations | Venezuela |
| Holz FG, Tadayoni R, Beatty S, Berger A, Cereda MG, Cortez R, Hoyng CB, Hykin P, Staurenghi G, Heldner S, Bogumil T, Heah T, Sivaprasad S. Multi-country real-life experience of anti-vascular endothelial growth factor therapy for wet age-related macular degeneration. Br J Ophthalmol. 2015 Feb;99(2):220-6. doi: 10.1136/bjophthalmol-2014-305327. Epub 2014 Sep 5. |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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