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LASER ADMINISTRATION FELLOW EYE (UNSCHEDULED) CRFs Roche FVF4170G Macular Edema NCT00473382

- 28.06.17 - 1 Formular, 2 Itemgruppen, 10 Datenelemente, 1 Sprache
Itemgruppen: Patient administration, LASER ADMINISTRATION STUDY EYE
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4168g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

CONCURRENT OCULAR PROCEDURES (DAY 0 - MONTH 12) CRFs Roche FVF4170G Macular Edema NCT00473382

- 11.06.17 - 1 Formular, 3 Itemgruppen, 12 Datenelemente, 1 Sprache
Itemgruppen: Patient administration, CONCURRENT OCULAR PROCEDURES (DAY 0 - MONTH 12), Procedure
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

SUBJECT ELIGIBILITY (SCREENING) CRFs Roche FVF4170G Macular Edema NCT-Nummer: NCT00473382

- 08.06.17 - 1 Formular, 3 Itemgruppen, 9 Datenelemente, 1 Sprache
Itemgruppen: Patient administration, SUBJECT ELIGIBILITY, Eligibility Criteria Not Met
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

Indirect Ophthalmoscopy Screening Ranibizumab Macular Edema Diabetes Mellitus FVF4170g - Indirect Ophthalmoscopy Screening

- 21.03.18 - 1 Formular, 4 Itemgruppen, 48 Datenelemente, 1 Sprache
Itemgruppen: 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, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus.

Slitlamp Examination Screening Ranibizumab Macular Edema Diabetes Mellitus FVF4170g - Slitlamp Examination Screening

- 21.03.18 - 1 Formular, 4 Itemgruppen, 48 Datenelemente, 1 Sprache
Itemgruppen: 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, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus.

Intraocular Pressure Screening Ranibizumab Macular Edema Diabetes Mellitus FVF4170g - Intraocular Pressure Screening

- 21.03.18 - 1 Formular, 1 Itemgruppe, 9 Datenelemente, 1 Sprache
Itemgruppe: Intraocular Pressure
Study part: Intraocular Pressure Screening. A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus.

4 Meter Visual Acuity/ Left Eye Chart 2 Screening Ranibizumab Macular Edema Diabetes Mellitus FVF4170g - 4 Meter Visual Acuity/ Left Eye Chart 2 Screening

- 21.03.18 - 1 Formular, 4 Itemgruppen, 28 Datenelemente, 1 Sprache
Itemgruppen: Visual acuity, Visual acuity, total score, Vision Tests
Study part: 4 Meter Visual Acuity/ Left Eye Chart 2 Screening. A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus.

4 Meter Visual Acuity/ Right Eye Chart 1 Ranibizumab Macular Edema Diabetes Mellitus FVF4170g - 4 Meter Visual Acuity/ Right Eye Chart 1

- 21.03.18 - 1 Formular, 4 Itemgruppen, 28 Datenelemente, 1 Sprache
Itemgruppen: Visual acuity, Visual acuity, total score, Vision Tests
Study part: 4 Meter Visual Acuity/ Right Eye Chart 1. A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus.

Physical Exam Screening Ranibizumab Macular Edema Diabetes Mellitus FVF4170g - Physical Exam Screening

- 21.03.18 - 1 Formular, 1 Itemgruppe, 5 Datenelemente, 1 Sprache
Itemgruppe: Physical examination
Study part: Physical Exam Screening. A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus.

Vital Signs Screening Ranibizumab Macular Edema Diabetes Mellitus FVF4170g - Vital Signs Screening

- 21.03.18 - 1 Formular, 1 Itemgruppe, 13 Datenelemente, 1 Sprache
Itemgruppe: Vital Signs
Study part: Vital Signs Screening. A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus.

Non Ocular Surgery/ Procedure History Screening Ranibizumab Macular Edema Diabetes Mellitus FVF4170g - Non Ocular Surgery/ Procedure History Screening

- 21.03.18 - 1 Formular, 1 Itemgruppe, 7 Datenelemente, 1 Sprache
Itemgruppe: Medical History surgery
Study part: Non Ocular Surgery/ Procedure History Screening. A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus.

General Medical History and Baseline Conditions Screening Ranibizumab Macular Edema Diabetes Mellitus FVF4170g - General Medical History and Baseline Conditions Screening

- 21.03.18 - 1 Formular, 1 Itemgruppe, 8 Datenelemente, 1 Sprache
Itemgruppe: Medical History
Study part: General Medical History and Baseline Conditions Screening. A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus.