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Common Data Elements for Retinal Neovascular Diseases - Risk Factors or Past Medical History

- 9/20/21 - 4 forms, 1 itemgroup, 35 items, 2 languages
Itemgroup: Risk Factors; Past Medical History
Common Data Elements for retinal neovascular diseases. The CDEs may be used in clinical routine, clinical trial, patient outcome, quality assurance and registry documentation of Age related macular degeneration (AMD), Diabetic Retinopathy (DR) and Retinal vein occlusion (RVO). The CDEs were developed by the Institute of Medical Informatics of the University Muenster in cooperation with the Department of Ophthalmology of the University Hospital Muenster.

Diagnosis and Examination

1 itemgroup 11 items

Eye Examination

1 itemgroup 18 items

Therapy

1 itemgroup 9 items

Demographics Screening Ranibizumab Macular Edema Secondary To Branch Retinal Vein Occlusion FVF4165g - Demographics Screening

- 9/17/21 - 1 form, 1 itemgroup, 7 items, 1 language
Itemgroup: Demography
Study part: Demographics Screening . A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection Compared With Sham In Subjects with Macular Edema Secondary To Branch Retinal Vein Occlusion.

Eligibility NCT01012973 Retinal Vein Occlusion - Eligibility

- 9/17/21 - 1 form, 2 itemgroups, 9 items, 2 languages
Itemgroups: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT01012973

4 Meter Visual Acuity/ Right Eye Chart 1 Day 0 Ranibizumab Macular Edema Secondary To Branch Retinal Vein Occlusion FVF4165g - 4 Meter Visual Acuity/ Right Eye Chart 1 Day 0

- 3/18/18 - 1 form, 4 itemgroups, 28 items, 1 language
Itemgroups: Visual acuity, Visual acuity, total score, Vision Tests
Study part: 4 Meter Visual Acuity/ Right Eye Chart 1 Day 0. A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection Compared With Sham In Subjects with Macular Edema Secondary To Branch Retinal Vein Occlusion.

Vital Signs Day 0 Ranibizumab Macular Edema Secondary To Branch Retinal Vein Occlusion FVF4165g - Vital Signs Day 0

- 3/18/18 - 1 form, 1 itemgroup, 11 items, 1 language
Itemgroup: Vital Signs
Study part: Vital Signs Day 0. A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection Compared With Sham In Subjects with Macular Edema Secondary To Branch Retinal Vein Occlusion.

Intraocular Pressure Screening Ranibizumab Macular Edema Secondary To Branch Retinal Vein Occlusion FVF4165g - Intraocular Pressure Screening

- 3/18/18 - 1 form, 1 itemgroup, 9 items, 1 language
Itemgroup: Intraocular Pressure
Study part: Intraocular Pressure Screening. A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection Compared With Sham In Subjects with Macular Edema Secondary To Branch Retinal Vein Occlusion.

Indirect Ophthalmoscopy Screening Ranibizumab Macular Edema Secondary To Branch Retinal Vein Occlusion FVF4165g - Indirect Ophthalmoscopy Screening

- 3/18/18 - 1 form, 4 itemgroups, 52 items, 1 language
Itemgroups: Indirect Ophthalmoscopy Right Eye, Indirect Ophthalmoscopy Left Eye , Retinal Break or Detachment right eye, Retinal Break or Detachment left eye
Study part: Indirect Ophthalmoscopy Screening. A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection Compared With Sham In Subjects with Macular Edema Secondary To Branch Retinal Vein Occlusion.

Language Used for Patient- Reported Outcome Questionnaires Day 0 Ranibizumab Macular Edema Secondary To Branch Retinal Vein Occlusion FVF4165g - Language Used for Patient- Reported Outcome Questionnaires Day 0

- 3/18/18 - 1 form, 1 itemgroup, 4 items, 1 language
Itemgroup: language
Study part: Language Used for Patient- Reported Outcome Questionnaires Day 0. A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection Compared With Sham In Subjects with Macular Edema Secondary To Branch Retinal Vein Occlusion.

Slitlamp Examination Screening Ranibizumab Macular Edema Secondary To Branch Retinal Vein Occlusion FVF4165g - Slitlamp Examination Screening

- 3/18/18 - 1 form, 4 itemgroups, 44 items, 1 language
Itemgroups: Slitlamp Examination Right Eye, Slitlamp Examination Left Eye , Findings of Inflammation right eye, Findings of Inflammation left eye
Study part: Slitlamp Examination Screening. A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection Compared With Sham In Subjects with Macular Edema Secondary To Branch Retinal Vein Occlusion.

4 Meter Visual Acuity/ Right Eye Chart 1 Ranibizumab Macular Edema Secondary To Branch Retinal Vein Occlusion FVF4165g - 4 Meter Visual Acuity/ Right Eye Chart 1

- 3/18/18 - 1 form, 4 itemgroups, 28 items, 1 language
Itemgroups: Visual acuity, Visual acuity, total score, Vision Tests
Study part: 4 Meter Visual Acuity/ Right Eye Chart 1. A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection Compared With Sham In Subjects with Macular Edema Secondary To Branch Retinal Vein Occlusion.

4 Meter Visual Acuity/ Left Eye Chart 2 Ranibizumab Macular Edema Secondary To Branch Retinal Vein Occlusion FVF4165g - 4 Meter Visual Acuity/ Left Eye Chart 2

- 3/18/18 - 1 form, 4 itemgroups, 28 items, 1 language
Itemgroups: Visual acuity, Visual acuity, total score, Vision Tests
Study part: 4 Meter Visual Acuity/ Left Eye Chart 2. A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection Compared With Sham In Subjects with Macular Edema Secondary To Branch Retinal Vein Occlusion.

Vital Signs Screening Ranibizumab Macular Edema Secondary To Branch Retinal Vein Occlusion FVF4165g - Vital Signs Screening

- 3/18/18 - 1 form, 1 itemgroup, 14 items, 1 language
Itemgroup: Vital Signs
Study part: Vital Signs Screening. A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection Compared With Sham In Subjects with Macular Edema Secondary To Branch Retinal Vein Occlusion.

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