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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005045-13 | EudraCT Number |
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The study is intended to characterize the clinical benefit regarding safety and efficacy of a long term treatment with Lucentis in comparison with Ozurdex over an additional 6 months and a 3-month follow-up period, following the initial 6-month treatment in the respective core studies CRFB002EDE17 (NCT01396057) and CRFB002EDE18 (NCT01396083).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab (Arm A) | Experimental | The PRN injection scheme applied in the core study will also be followed during this extension study: Patients should be monitored monthly (starting at V1E) for VA and treatment is to be resumed when monitoring indicates loss of VA due to disease activity. Monthly injections should then be administered until stable VA is reached again for 3 consecutive monthly assessments (implying a minimum of 2 injections during stable VA). The interval between 2 doses should not be shorter than 1 month |
|
| Dexamethasone (Arm B) | Sham Comparator | A PRN re-treatment scheme will be applied for the Ozurdex arm during this extension study, i.e. patients may receive an implant at V1E or later as needed: Patients should be monitored monthly and if there is a decline from stable VA stability due to macular edema patients will receive another intravitreal implant. (700 µg; long acting release (LAR)) given that in the opinion of the investigator the patient would benefit from the re-treatment. However, a minimum period of 5 months in between implantations is required. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RFB002 | Biological | 0.5 mg/0.05 mL solution to be injected intravitreally. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial. Each vial contained ranibizumab in an aqueous solution (pH 5.5) with histidine, trehalose and polysorbate 20. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | The number of participants who experienced Adverse events, serious AE and death | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Raw Mean Best Corrected Visual Acuity (BCVA) by Treatment Group | 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. An ETDRS visual acuity score of 85 is approximately 20/20. The range of BCVA (EDTRS) is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement |
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Inclusion Criteria:
Exclusion Criteria:
Patients who experienced an uncontrollable rise in IOP during the core study CRFB002EDE17 respectively CRFB002EDE18, i.e. IOP could not be decreased to a stable level of < 25mmHg.
Use of other investigational drugs
Current use or likely need of systemic medications known to be toxic to the lens, retina or optic nerve
History of hypersensitivity to Ranibizumab or Ozurdex or any component of the ranibizumab respectively Ozurdey formulation
Any type of advanced, severe or unstable disease or its treatment, that could interfere with evaluations or put the patient at special risk
Women
who were pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>5 mIU/mL)
who were menstruating and capable of becoming pregnant* and not practicing a medically approved method of contraception (Pearl Index <1**)*** during and up to at least 4 weeks after the end of treatment. A negative pregnancy test (serum) for all women and for girls entering menarche was required with sufficient lead time before randomization
definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/mL or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy
examples of particularly reliable methods with Pearl Index (PI) <1, according to guidelines of "Deutsche Gesellschaft für Gynäkologie und Geburtshilfe":
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Leipzig | Germany | 04103 | Germany | ||
| Novartis Investigative Site |
The Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. LOCF=last observation carried forward
A total of 140 patients with (BRVO) completed the core study CRFB002EDE17, and 127 patients with (CRVO) completed the core study CRFB002EDE18. 92 patients with BRVO and 83 patients with CRVO were enrolled into the extension study. A total of 175 patients (113 in the ranibizumab group and 62 in the dexamethasone group) were enrolled
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranibizumab (BRVO) | Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally |
| FG001 | Dexamethasone (BRVO) | A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Dexamethasone | Drug | Ozurdex (Dexamethasone): intravitreal implant as per commercial label (700 µg Dexamethasone; Dexamethasone was formulated as a rod shaped implant to be inserted into the eye by an applicator. The implant as well as the respective applicator were suitable for single use only. Dexamethasone had to be stored according to label instructions and it had to be kept in a secure locked facility |
|
| Baseline, 6 months and 12 months |
| Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters at Month 12 Compared to Baseline | BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who were gaining/losing ≥15, 10 or 5 more letters of visual acuity at month 12 as compared with baseline | 12 month |
| Change in Central Subfield Thickness (CSRT) From Baseline to Month 12 | High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center. | Baseline , Month 12 |
| Change of Foveal Center Point Thickness (FCPT) From Baseline to Month 12 | FCPT (foveal center point thickness) was assessed by central reading center to ensure error- corrected measurements of retinal thickness and volumes, | Baseline, Month 12 |
| Change in Mean Visual Function Questionnaire (VFQ-25) | The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function. | Baseline, 12 months |
| Change in SF-36 Summary Scores | The SF-36 measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health. A positive change from Baseline score indicates improvement in quality of life. | Baseline, month 12 |
| Change in Euro Quality of Life Questionnaire (EQ-5D) VAS Summary Scores | The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Participants self-rate their health on a visual, vertical analogue scale from 0 to 100 where the endpoints are labeled "Best imaginable health state" (100) and "worst imaginable health state" (0). | Baseline, month 12 |
| Time to the First Retreatment of Both Treatment Arms | Time to the first retreatment | 6 months |
| Regensburg |
| Germany |
| 93042 |
| Germany |
| Novartis Investigative Site | Augsburg | 85155 | Germany |
| Novartis Investigative Site | Bad Rothenfelde | 49214 | Germany |
| Novartis Investigative Site | Berlin | 10713 | Germany |
| Novartis Investigative Site | Berlin | 13353 | Germany |
| Novartis Investigative Site | Bonn | 53127 | Germany |
| Novartis Investigative Site | Bremen | 28209 | Germany |
| Novartis Investigative Site | Chemnitz | 09113 | Germany |
| Novartis Investigative Site | Cologne | 50935 | Germany |
| Novartis Investigative Site | Darmstadt | 64297 | Germany |
| Novartis Investigative Site | Dresden | 01307 | Germany |
| Novartis Investigative Site | Düsseldorf | 40212 | Germany |
| Novartis Investigative Site | Düsseldorf | 40225 | Germany |
| Novartis Investigative Site | Frankfurt | 60318 | Germany |
| Novartis Investigative Site | Freiburg I. Br | 79106 | Germany |
| Novartis Investigative Site | Glauchau | 08371 | Germany |
| Novartis Investigative Site | Göttingen | 37075 | Germany |
| Novartis Investigative Site | Halle | 06114 | Germany |
| Novartis Investigative Site | Hamburg | 20246 | Germany |
| Novartis Investigative Site | Ingolstadt | 85049 | Germany |
| Novartis Investigative Site | Karlsruhe | 76133 | Germany |
| Novartis Investigative Site | Karlsruhe | 76199 | Germany |
| Novartis Investigative Site | Ludwigshafen | 67063 | Germany |
| Novartis Investigative Site | Marburg | 35039 | Germany |
| Novartis Investigative Site | Minden | 32427 | Germany |
| Novartis Investigative Site | Mülheim | 45468 | Germany |
| Novartis Investigative Site | München | 80336 | Germany |
| Novartis Investigative Site | München | 81675 | Germany |
| Novartis Investigative Site | Münster | 48145 | Germany |
| Novartis Investigative Site | Münster | 48149 | Germany |
| Novartis Investigative Site | Recklinghausen | 45657 | Germany |
| Novartis Investigative Site | Sulzbach | 66280 | Germany |
| Novartis Investigative Site | Tübingen | 72076 | Germany |
| Novartis Investigative Site | Ulm | 89075 | Germany |
| Novartis Investigative Site | Wolfsburg | 38442 | Germany |
| Novartis Investigative Site | Würzburg | 97080 | Germany |
| FG002 | Ranibizumab (CRVO) | Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitrally |
| FG003 | Dexamethasone (CRVO) | A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ranibizumab | Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally |
| BG001 | Dexamethasone | A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | The number of participants who experienced Adverse events, serious AE and death | The Safety Set consisted of all patients from the safety sets of the respective core study who had received at least one application of study treatment and had at least one safety assessment during the extension study. Patients were analyzed according to treatment received. | Posted | Number | Participants | 6 months |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Raw Mean Best Corrected Visual Acuity (BCVA) by Treatment Group | 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. An ETDRS visual acuity score of 85 is approximately 20/20. The range of BCVA (EDTRS) is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement | FAS consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned. | Posted | Mean | Standard Deviation | Letters read correctly | Baseline, 6 months and 12 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters at Month 12 Compared to Baseline | BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who were gaining/losing ≥15, 10 or 5 more letters of visual acuity at month 12 as compared with baseline | Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned | Posted | Number | Percentage of participants | 12 month |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in Central Subfield Thickness (CSRT) From Baseline to Month 12 | High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center. | Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned. | Posted | Mean | Standard Deviation | um | Baseline , Month 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change of Foveal Center Point Thickness (FCPT) From Baseline to Month 12 | FCPT (foveal center point thickness) was assessed by central reading center to ensure error- corrected measurements of retinal thickness and volumes, | Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned. | Posted | Mean | Standard Deviation | um | Baseline, Month 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Mean Visual Function Questionnaire (VFQ-25) | The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function. | Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 12 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in SF-36 Summary Scores | The SF-36 measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health. A positive change from Baseline score indicates improvement in quality of life. | Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, month 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Euro Quality of Life Questionnaire (EQ-5D) VAS Summary Scores | The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Participants self-rate their health on a visual, vertical analogue scale from 0 to 100 where the endpoints are labeled "Best imaginable health state" (100) and "worst imaginable health state" (0). | Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, month 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to the First Retreatment of Both Treatment Arms | Time to the first retreatment | The Safety Set consisted of all patients from the safety sets of the respective core study who had received at least one application of study treatment and had at least one safety assessment during the extension study. Patients were analyzed according to treatment received. | Posted | Median | 95% Confidence Interval | Days | 6 months |
|
Not provided
The Safety Set consisted of all patients from the safety sets of the respective core study who had received at least one application of study treatment and had at least one safety assessment during the extension study. Patients were analyzed according to treatment received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ranibizumab (BRVO) | Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally | 2 | 52 | 35 | 52 | ||
| EG001 | Dexamethasone (BRVO) | A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required | 3 | 40 | 28 | 40 | ||
| EG002 | Ranibizumab (CRVO) | Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally | 6 | 61 | 45 | 61 | ||
| EG003 | Dexamethasone (CRVO) | A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required | 1 | 22 | 16 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GLAUCOMA (Fellow eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| GLAUCOMA (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| IRIS NEOVASCULARISATION (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| MACULAR OEDEMA (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| OCULAR ISCHAEMIC SYNDROME (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| RETINAL DETACHMENT (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| VISUAL ACUITY REDUCED (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| VITREOUS HAEMORRHAGE (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF SKIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| LUMBAR RADICULOPATHY | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| SUBSTANCE ABUSE | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FACTOR V LEIDEN MUTATION | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
| |
| CATARACT (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| CONJUNCTIVAL HAEMORRHAGE (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| CONJUNCTIVAL HYPERAEMIA (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| CONJUNCTIVAL IRRITATION (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| CONJUNCTIVITIS ALLERGIC (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| DRY EYE (Fellow eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| DRY EYE (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| EYE PAIN (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| FOREIGN BODY SENSATION IN EYES (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| GLAUCOMA (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| LACRIMATION INCREASED (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| MACULAR FIBROSIS (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| MACULAR OEDEMA (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| OCULAR DISCOMFORT (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| OCULAR HYPERAEMIA (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| PHOTOPSIA (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| RETINAL EXUDATES (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| RETINAL ISCHAEMIA (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| RETINAL OEDEMA (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| VISION BLURRED (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| VISUAL ACUITY REDUCED (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| VISUAL IMPAIRMENT (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| VITREOUS DETACHMENT (Fellow eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| VITREOUS DETACHMENT (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| CHEST DISCOMFORT | General disorders | MedDRA | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| CONJUNCTIVITIS (Study eye) | Infections and infestations | MedDRA | Systematic Assessment |
| |
| CYSTITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| GASTROINTESTINAL INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| PERIODONTITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| MUSCLE STRAIN | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| POST PROCEDURAL SWELLING (Study eye) | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA | Systematic Assessment |
| |
| INTRAOCULAR PRESSURE DECREASED (Study eye) | Investigations | MedDRA | Systematic Assessment |
| |
| INTRAOCULAR PRESSURE INCREASED (Study eye) | Investigations | MedDRA | Systematic Assessment |
| |
| VITAMIN D DEFICIENCY | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| SJOGREN'S SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| SCIATICA | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| TRIGEMINAL NEURALGIA | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA | Systematic Assessment |
|
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 | 862-778-8300 | trialandresults.registries@novartis.com |
| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| D008268 | Macular Degeneration |
| D008269 | Macular Edema |
| D020256 | Choroidal Neovascularization |
| D012816 | Signs and Symptoms |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D015354 | Vision, Low |
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015785 | Eye Diseases, Hereditary |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| Male |
|
| Serious adverse event |
|
| Death |
|
| Ranibizumab (CRVO) |
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally |
| OG003 | Dexamethasone (CRVO) | A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required |
|
|
| OG002 | Ranibizumab (CRVO) | Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally |
| OG003 | Dexamethasone (CRVO) | A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required |
|
|
| OG002 |
| Ranibizumab (CRVO) |
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally |
| OG003 | Dexamethasone (CRVO) | A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required |
|
|
| OG003 | Dexamethasone (CRVO) | A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required |
|
|
| OG002 | Ranibizumab (CRVO) | Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally |
| OG003 | Dexamethasone (CRVO) | A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required |
|
|
| OG002 | Ranibizumab (CRVO) | Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally |
| OG003 | Dexamethasone (CRVO) | A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required |
|
|
| OG002 |
| Ranibizumab (CRVO) |
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally |
| OG003 | Dexamethasone (CRVO) | A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required |
|
|
A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required |
|
|