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Ranibizumab is a humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody fragment approved in Chile by the Instituto de Salud Pública for the treatment of diabetic macular edema (DME), retinal vein occlusion and age-related macular degeneration.
Currently, there is limited epidemiologic information in Chile regarding the incidence of DME and limited experience of anti-VEGF hospital therapy. This study will evaluate the efficacy of intravitreal ranibizumab in Chilean DME patients, to investigate the anatomical and functional improvement following this treatment and to increase the local experience regarding the use of anti-VEGF in the treatment of diabetic macular edema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab | Experimental | Ranibizumab treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab Intravitreal injections | Drug | Ranibizumab intravitreal injections 3 months 1 per month and after PRN treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Best Correct Visual Acuity (BCVA) | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement. | baseline, week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Best-corrected Visual Acuity (BCVA) After Week 4, 8, 12, 24 and 36 | BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement. | Baseline, Week 4, 8, 12, 24 and 36 |
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Inclusion Criteria:
Exclusion Criteria:
Any other protocol inclusion/exclusion criteria that 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 | Providencia | Santiago de Chile | 7510168 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15111519 | Background | Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53. doi: 10.2337/diacare.27.5.1047. | |
| 12941734 | Result | Ciulla TA, Amador AG, Zinman B. Diabetic retinopathy and diabetic macular edema: pathophysiology, screening, and novel therapies. Diabetes Care. 2003 Sep;26(9):2653-64. doi: 10.2337/diacare.26.9.2653. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranibizumab | Ranibizumab 0.5 mg administered as an intravitreal injection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Change Over Time of the Intraretinal Thickness in Optical Coherence Tomography (OCT) | Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation, an increase in thickness as compared to baseline may indicate a progression of the underlying disease. | Baseline, week 48 |
| Number of Participants Receiving Injections of Ranibizumab 0.5 mg Over a 48 Week Treatment Period. | Week 48 |
| Number of Participants With Letters Gain / Loss at Week 52 | Number of participants with letters correctly identified were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters. | Baseline, Week 52 |
| Change in Mean Visual Function Questionnaire (VFQ-25) | "Visual functioning was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in visual functioning, while a negative change value indicates a worsening." | Baseline, week 48 |
| COMPLETED |
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| NOT COMPLETED |
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Full Analysis Set (FAS) include all patients who received at least one dose of study medication, and have at least one post-baseline efficacy assessment. The FAS is analyzed according to the intention to treat ideal.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranibizumab | Ranibizumab 0.5 mg administered as an intravitreal injection |
| 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 | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | 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 Change From Baseline in Best Correct Visual Acuity (BCVA) | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement. | Full Analysis Set (FAS) include all patients who received at least one dose of study medication, and have at least one post-baseline efficacy assessment. The FAS is analyzed according to the intention to treat ideal. | Posted | Mean | Standard Deviation | Letters | baseline, week 48 |
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| Secondary | Change From Baseline in Best-corrected Visual Acuity (BCVA) After Week 4, 8, 12, 24 and 36 | BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement. | Full Analysis Set (FAS) include all patients who received at least one dose of study medication, and have at least one post-baseline efficacy assessment. The FAS is analyzed according to the intention to treat ideal | Posted | Mean | Standard Deviation | Letters | Baseline, Week 4, 8, 12, 24 and 36 |
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| Secondary | Change Over Time of the Intraretinal Thickness in Optical Coherence Tomography (OCT) | Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation, an increase in thickness as compared to baseline may indicate a progression of the underlying disease. | Full Analysis Set (FAS) include all patients who received at least one dose of study medication, and have at least one post-baseline efficacy assessment. The FAS is analyzed according to the intention to treat ideal | Posted | Mean | Standard Deviation | Microns | Baseline, week 48 |
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| Secondary | Number of Participants Receiving Injections of Ranibizumab 0.5 mg Over a 48 Week Treatment Period. | Full Analysis Set (FAS) include all patients who received at least one dose of study medication, and have at least one post-baseline efficacy assessment. The FAS is analyzed according to the intention to treat ideal | Posted | Number | Count of participants | Week 48 |
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| Secondary | Number of Participants With Letters Gain / Loss at Week 52 | Number of participants with letters correctly identified were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters. | Full Analysis Set (FAS) include all patients who received at least one dose of study medication, and have at least one post-baseline efficacy assessment. The FAS is analyzed according to the intention to treat ideal | Posted | Number | Count of Participants | Baseline, Week 52 |
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| Secondary | Change in Mean Visual Function Questionnaire (VFQ-25) | "Visual functioning was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in visual functioning, while a negative change value indicates a worsening." | Full Analysis Set (FAS) include all patients who received at least one dose of study medication, and have at least one post-baseline efficacy assessment. The FAS is analyzed according to the intention to treat ideal | Posted | Mean | Standard Deviation | Score on a scale | Baseline, week 48 |
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Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
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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 | Ranibizumab 0.5 mg | Ranibizumab 0.5 mg administered as an intravitreal injection | 0 | 21 | 6 | 21 | 17 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA (20.1) | Systematic Assessment |
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| Vitreous haemorrhage | Eye disorders | MedDRA (20.1) | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA (20.1) | Systematic Assessment |
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| Conjunctivitis allergic | Eye disorders | MedDRA (20.1) | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA (20.1) | Systematic Assessment |
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| Ocular hypertension | Eye disorders | MedDRA (20.1) | Systematic Assessment |
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| Visual impairment | Eye disorders | MedDRA (20.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Nodule | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA (20.1) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Viral pharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
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| Foreign body in eye | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
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| Joint injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA (20.1) | Systematic Assessment |
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| Diabetic metabolic decompensation | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
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| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
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| Anxiety disorder | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Menopause | Social circumstances | MedDRA (20.1) | Systematic Assessment |
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| Carpal tunnel decompression | Surgical and medical procedures | MedDRA (20.1) | 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 (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-1873 |
| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012162 | Retinal Degeneration |
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