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Ranibizumab, Lucentis®) Clinical Development RFB002 (Ranibizumab, Lucentis®) Clinical Trial Protocol CRFB002DDE26 / NCT02366468 A 12-months, randomized, VA-assessor blinded, multicenter, controlled phase IV trial to investigate non- inferiority of two treatment algorithms (discretion of the investigator vs. pro re nata) of 0.5 mg ranibizumab in patients with visual impairment due to diabetic macula edema Authors: Document type: Clinical Trial Protocol EUDRACT number: 2014-002854-37 Version number: v01 (incl. Amendment 01) Development phase: IV Release date: 18-04-2016 Property of Novartis Confidential May not be used, divulged, published, or otherwise disclosed without the consent of Novartis NOVDD Template Version 03-Feb-2012 Novartis Confidential Page 2 Clinical Trial Protocol (Version No. 01) Protocol No. CRFB002DDE26 Table of contents Table of contents ................................................................................................................. 2 List of tables ........................................................................................................................ 5 List of figures ...................................................................................................................... 5 List of abbreviations ............................................................................................................ 6 Glossary of terms ................................................................................................................. 8 Summary of protocol amendments ...................................................................................... 9 Protocol synopsis ............................................................................................................... 12 1 Introduction ....................................................................................................................... 16 1.1 Background ............................................................................................................ 16 1.2 Purpose .................................................................................................................. 17 2 Study objectives ................................................................................................................. 17 2.1 Primary and key secondary objectives .................................................................. 17 2.1.1 Primary objective .................................................................................. 17 2.1.2 Secondary objectives ............................................................................. 17 17 3 Investigational plan ........................................................................................................... 18 3.1 Study design........................................................................................................... 18 3.2 Rationale of study design ....................................................................................... 19 3.3 Rationale of dose/regimen, route of administration and duration of treatment ..... 20 3.4 Rationale for choice of comparator ....................................................................... 21 3.5 Purpose and timing of interim analyses/design adaptations .................................. 21 3.6 Risks and benefits .................................................................................................. 21 4 Population .......................................................................................................................... 22 4.1 Inclusion criteria .................................................................................................... 22 4.2 Exclusion criteria ................................................................................................... 23 5 Treatment ........................................................................................................................... 26 5.1 Protocol requested treatment ................................................................................. 26 5.1.1 Investigational treatment ....................................................................... 26 5.1.2 Additional study treatment .................................................................... 26 5.2 Treatment arms ...................................................................................................... 26 5.3 Treatment assignment, randomization ................................................................... 26 5.4 Treatment masking ................................................................................................ 27 5.5 Treating the patient ................................................................................................ 27 5.5.1 Patient numbering ................................................................................. 27 5.5.2 Dispensing the investigational treatment .............................................. 27 Novartis Confidential Page 3 Clinical Trial Protocol (Version No. 01) Protocol No. CRFB002DDE26 5.5.3 Handling of study treatment .................................................................. 28 5.5.4 Instructions for prescribing and taking study treatment ........................ 30 5.5.5 Permitted dose adjustments and interruptions of study treatment ........ 30 5.5.6 Rescue medication ................................................................................ 30 5.5.7 Concomitant treatment .......................................................................... 31 5.5.8 Prohibited Treatment ............................................................................. 31 5.5.9 Discontinuation of study treatment and premature patient withdrawal ............................................................................................. 31 5.5.10 Emergency breaking of treatment assignment ...................................... 32 5.5.11 Study completion and post-study treatment .......................................... 32 5.5.12 Early study termination ......................................................................... 33 6 Visit schedule and assessments ......................................................................................... 33 6.1 Information to be collected on screening failures.................................................. 37 6.2 Patient demographics/other baseline characteristics ............................................. 37 6.3 Treatment exposure and compliance ..................................................................... 38 6.4 Efficacy .................................................................................................................. 38 6.4.1 Best corrected visual acuity .................................................................. 38 6.4.2 Optical Coherence Tomography ........................................................... 39 6.4.3 Color Fundus Photography .................. 39 6.4.4 Appropriateness of efficacy assessments .............................................. 40 6.5 Safety ..................................................................................................................... 40 6.5.1 Physical Examination ............................................................................ 40 6.5.2 Vital signs.............................................................................................. 40 6.5.3 Height and Weight ................................................................................ 40 6.5.4 Laboratory evaluations .......................................................................... 40 6.5.5 Pregnancy and assessments of fertility ................................................. 40 6.5.6 Eye-specific safety monitoring ............................................................. 40 6.5.7 Gonioscopy ........................................................................................... 42 6.5.8 Hematology ........................................................................................... 42 6.5.9 Clinical chemistry ................................................................................. 42 6.5.10 Urinalysis .............................................................................................. 42 6.5.11 Electrocardiogram (ECG) ..................................................................... 42 6.5.12 Appropriateness of safety measurements .............................................. 42 6.6 Other assessments .................................................................................................. 42 6.6.1 Resource utilization ............................................................................... 42 43 Novartis Confidential Page 4 Clinical Trial Protocol (Version No. 01) Protocol No. CRFB002DDE26 6.6.3 Pharmacokinetics .................................................................................. 43 6.6.4 Pharmacogenetics (optional) ................................................................. 43 6.6.5 Other biomarkers ................................................................................... 43 43 43 44 7 Safety monitoring .............................................................................................................. 44 7.1 Adverse events ....................................................................................................... 44 7.2 Serious adverse event reporting ............................................................................. 46 7.3 Liver safety monitoring ........................................................................................
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