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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002854-37 | EudraCT Number |
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The purpose of this study was to demonstrate that the change of best corrected visual acuity (BCVA) was comparable in patients treated with ranibizumab at the discretion of the investigator vs. treatment according to a standard of care scheme (pro re nata, as needed).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Discretion of the investigator (DI) | Experimental | ranibizumab 0.5 mg, after initial monthly treatment until maximum BCVA and no signs or no further change of disease activity, the investigator treated patients at their own discretion. There were no strict recommendations for retreatment or scheduling of upcoming visits. |
|
| Pro re nata (PRN) | Active Comparator | ranibizumab 0.5 mg, after initial monthly therapy until maximum BCVA and no signs or no further improvement of disease activity, patients were monitored every month and retreated if any signs of disease activity occurred |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab 0.5 mg | Drug | intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Average Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye From Month 1 to Study Treatment Completion (Month 12) | BCVA was assessed as letters read using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. The mean average change from baseline was defined as the difference between the average level of BCVA (ETDRS letters) over all post-baseline assessments from Month 1 to Month 12. A positive change represents an improvement in visual acuity | Baseline, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Visits | Mean number of visits during the study | Baseline to Month 12 |
| Number of Injections | mean number of injections in the study eye during the study |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Ahaus | 48683 | Germany | |||
| Novartis Investigative Site |
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At Screening, the eligibility criteria were performed.
a total of 135 patients were randomized and assigned in a 1:1 ratio to the treatment arms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Discretion of the Investigator (DI) | Investigational - ranibizumab 0.5 mg |
| FG001 | Pro re Nata (PRN) | Standard of Care - ranibizumab 0.5 mg |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 18, 2016 | Jun 5, 2018 |
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| Baseline to Month 12 |
| Number of Treatment Free Intervals | A treatment-free interval is the interval between the first NO treatment given when the reason for NO treatment given is one of the three stability criteria and the first subsequent YES treatment given after that. | Baseline to Month 12 |
| Mean Change in Central Subfield Retinal Thickness (CSRT) | Evaluated by central reading center assessing OCT images | Baseline to Month 12 |
| Mean Change of Foveal Center Point Thickness | Evaluated by central reading center assessing OCT images | Baseline to Month 12 |
| Number of Participants With Change in Diabetic Retinopathy Study (DRS) Retinopathy Scale | Evaluated by central reading center scoring fundus photography | Baseline to Month 12 |
| Bayreuth |
| 95444 |
| Germany |
| Novartis Investigative Site | Berlin | 12203 | Germany |
| Novartis Investigative Site | Berlin | 14169 | Germany |
| Novartis Investigative Site | Bonn | 53127 | Germany |
| Novartis Investigative Site | Cologne | 50924 | Germany |
| Novartis Investigative Site | Cologne | 50935 | Germany |
| Novartis Investigative Site | Dresden | 01067 | Germany |
| Novartis Investigative Site | Düsseldorf | 40212 | Germany |
| Novartis Investigative Site | Düsseldorf | 40225 | Germany |
| Novartis Investigative Site | Freiburg I. Br | 79106 | Germany |
| Novartis Investigative Site | Göttingen | 37075 | Germany |
| Novartis Investigative Site | Greifswald | 17475 | Germany |
| Novartis Investigative Site | Halle | 06114 | Germany |
| Novartis Investigative Site | Hamburg | 20246 | Germany |
| Novartis Investigative Site | Hösbach | 63768 | Germany |
| Novartis Investigative Site | Kempten | 87435 | Germany |
| Novartis Investigative Site | Leipzig | 04103 | Germany |
| Novartis Investigative Site | Ludwigshafen | 67063 | Germany |
| Novartis Investigative Site | Lübeck | 23538 | Germany |
| Novartis Investigative Site | Magdeburg | 39108 | Germany |
| Novartis Investigative Site | Marburg | 35043 | Germany |
| Novartis Investigative Site | München | 80333 | Germany |
| Novartis Investigative Site | München | 81675 | Germany |
| Novartis Investigative Site | Münster | 48145 | Germany |
| Novartis Investigative Site | Münster | 48149 | Germany |
| Novartis Investigative Site | Stuttgart | 70174 | Germany |
| Novartis Investigative Site | Tübingen | 72076 | Germany |
| Novartis Investigative Site | Ulm | 89075 | Germany |
| Novartis Investigative Site | Würzburg | 97080 | Germany |
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| Full Analysis Set (FAS) | Randomized patients who received study treatment and had post-baseline primary endpoint assessments |
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| Per Protocol Set (PPS) | All patients in the FAS who completed the trial without major protocol deviations |
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| COMPLETED |
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| NOT COMPLETED |
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Full analysis set (FAS). All patients randomized who received at least one application of study treatment and had at least one post-baseline assessment for the primary endpoint (BCVA).
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| ID | Title | Description |
|---|---|---|
| BG000 | Discretion of the Investigator (DI) | Investigational - ranibizumab 0.5 mg |
| BG001 | Pro re Nata (PRN) | Standard of Care - ranibizumab 0.5 mg |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | FAS | Mean | Standard Deviation | years |
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| Sex: Female, Male | FAS | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Average Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye From Month 1 to Study Treatment Completion (Month 12) | BCVA was assessed as letters read using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. The mean average change from baseline was defined as the difference between the average level of BCVA (ETDRS letters) over all post-baseline assessments from Month 1 to Month 12. A positive change represents an improvement in visual acuity | FAS - Last Observation Carried Forward (LOCF) | Posted | Mean | Standard Deviation | Letters | Baseline, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 |
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| Secondary | Number of Visits | Mean number of visits during the study | FAS | Posted | Mean | Standard Deviation | Visits | Baseline to Month 12 |
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| Secondary | Number of Injections | mean number of injections in the study eye during the study | FAS | Posted | Mean | Standard Deviation | Injections | Baseline to Month 12 |
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| Secondary | Number of Treatment Free Intervals | A treatment-free interval is the interval between the first NO treatment given when the reason for NO treatment given is one of the three stability criteria and the first subsequent YES treatment given after that. | FAS - including only patients with at least one treatment-free interval | Posted | Mean | Standard Deviation | Intervals | Baseline to Month 12 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in Central Subfield Retinal Thickness (CSRT) | Evaluated by central reading center assessing OCT images | FAS - Last Observation Carried Forward (LOCF) | Posted | Mean | Standard Deviation | μm | Baseline to Month 12 |
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| Secondary | Mean Change of Foveal Center Point Thickness | Evaluated by central reading center assessing OCT images | FAS - LOCF - including only patients with assessments | Posted | Mean | Standard Deviation | μm | Baseline to Month 12 |
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| Secondary | Number of Participants With Change in Diabetic Retinopathy Study (DRS) Retinopathy Scale | Evaluated by central reading center scoring fundus photography | FAS - LOCF - including only patients with assessments | Posted | Count of Participants | Participants | No | Baseline to Month 12 |
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From start of study treatment until month 12
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Discretion of the Investigator (DI) | Investigational - ranibizumab 0.5 mg | 1 | 68 | 13 | 68 | 44 | 68 |
| EG001 | Pro re Nata (PRN) | Standard of Care - ranibizumab 0.5 mg | 2 | 67 | 22 | 67 | 43 | 67 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
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| Heart valve incompetence | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Eyelid function disorder | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (20.0) | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| Endophthalmitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| VIIth nerve injury | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA (20.0) | Systematic Assessment |
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| Urinary nitrogen increased | Investigations | MedDRA (20.0) | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
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| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
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| Acoustic neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
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| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
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| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
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| Balance disorder | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
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| Diabetic neuropathy | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
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| Facial paralysis | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
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| Hydrocephalus | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
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| Disorientation | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
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| Nephrotic syndrome | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
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| Behcet's syndrome | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
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| Circulatory collapse | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA (20.0) | Systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | MedDRA (20.0) | Systematic Assessment |
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| Corneal erosion | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Foreign body sensation in eyes | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Macular oedema | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Ocular discomfort | Eye disorders | MedDRA (20.0) | Systematic Assessment |
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| Visual acuity reduced | Eye disorders | MedDRA (20.0) | Systematic Assessment |
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| Visual impairment | Eye disorders | MedDRA (20.0) | Systematic Assessment |
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| Vitreous floaters | Eye disorders | MedDRA (20.0) | Systematic Assessment |
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| Vitreous haemorrhage | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Glycosylated haemoglobin increased | Investigations | MedDRA (20.0) | Systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA (20.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 13, 2018 | Jun 5, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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| Male |
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| Black |
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| Asian |
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| Other |
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| Visit-averaged change from baseline |
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