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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002350-31 | EudraCT Number |
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The present study provided additional efficacy and safety data for 0.5-mg ranibizumab using as needed (PRN) dosing over 24 months in patients with visual impairment due to macular edema secondary to Central Retinal Vein Occlusion (CRVO). Spectral domain high-definition optical coherence tomography (OCT) images was analyzed to gain insights into predictive factors for disease progression and the possibility of reduced monitoring was assessed in Year 2. The results of this open-label study provided long-term safety and efficacy data to further guide recommendations on the use of ranibizumab in this indication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab arm | Experimental | Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab 0.5 mg/0.05 ml | Drug | Patients will receive the first dose at Baseline, as an intravitreal injection with a standard dose of 0.5 mg/0.05 ml. Patients will receive at least 3 study treatments at monthly intervals (Day 1, Month 1 and Month 2). The last mandatory dose during treatment initiation will be administered approximately 60 days after the first study treatment. If there is no improvement in VA over the course of the first 3 injections, continued treatment is not recommended and the patient may receive alternative treatment at the investigator's discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Best Corrected Visual Acuity (BCVA) at Month 12 Compared to Baseline | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement | Baseline to month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Best Corrected Visual Acuity (BCVA) at Month 24 Compared to Baseline | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Parramatta | New South Wales | 2150 | Australia | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34934034 | Derived | Pawloff M, Bogunovic H, Gruber A, Michl M, Riedl S, Schmidt-Erfurth U. SYSTEMATIC CORRELATION OF CENTRAL SUBFIELD THICKNESS WITH RETINAL FLUID VOLUMES QUANTIFIED BY DEEP LEARNING IN THE MAJOR EXUDATIVE MACULAR DISEASES. Retina. 2022 May 1;42(5):831-841. doi: 10.1097/IAE.0000000000003385. | |
| 31047340 | Derived |
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No data were excluded from the Full Analysis Set (FAS )analyses because of protocol deviations.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranibizumab Arm | Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Baseline to Month 24 |
| Mean Average Change in Best Corrected Visual Acuity (BCVA From Baseline Month 12 and Month 24 | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 12 (or Month 24). Then, mean average change is calculated as the average of average changes across all patients. | Baseline and Month 1 to 12 or Month 24 |
| Mean Average Change in BCVA From First Treatment Interruption (Due to BCVA Stabilization) to Month 12 and Month 24 | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. Stability in visual acuity after treatment interruption indicates longer duration of the drug efficacy | Month 12 and Month 24 |
| Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 and Month 24 in the Study Eye | 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 increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters of visual acuity at month 12 as compared with baseline | Month 12 and Month 24 |
| Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 and Month 24 | Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at month 12 and month 24 indicates a positive outcome. | Month 12 and Month 24 |
| Mean Change in Central Reading Center (CRC)-Assessed Central Subfield Thickness (CSFT) From Month 12 and Month 24 Compared to Baseline | Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation | Baseline, Month 12 and Month 24 |
| Mean Change in Patient-reported Outcomes in NEI-VFQ-25 Composite and Subscale Scores at Month 12 and Month 24 Compared to Baseline | The survey consists of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranges from 0 (worst) to 100 which indicates the best possible response. The composite score and score of each of each construct also range from 0 to 100 as they are calculated as total scores divided by the number of questions. The higher the values of total scores represent better outcome. Scores per visit and of the change descriptively by visit. | Month 12 and Month 24 |
| Sydney |
| New South Wales |
| 2000 |
| Australia |
| Novartis Investigative Site | Melbourne | Victoria | 3002 | Australia |
| Novartis Investigative Site | Nedlands | Western Australia | 6009 | Australia |
| Novartis Investigative Site | Vienna | Austria | 1090 | Austria |
| Novartis Investigative Site | Linz | 4021 | Austria |
| Novartis Investigative Site | Calgary | Alberta | T2H0C8 | Canada |
| Novartis Investigative Site | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Novartis Investigative Site | Victoria | British Columbia | V8V 4X3 | Canada |
| Novartis Investigative Site | London | Ontario | N6A 4G5 | Canada |
| Novartis Investigative Site | Boisbriand | Quebec | J7H 1S6 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H1T 2M4 | Canada |
| Novartis Investigative Site | Olomouc | 775 20 | Czechia |
| Novartis Investigative Site | Prague | 100 34 | Czechia |
| Novartis Investigative Site | Glostrup Municipality | DK-2600 | Denmark |
| Novartis Investigative Site | Pátrai | Greece | 26504 | Greece |
| Novartis Investigative Site | Thessaloniki | Greece | GR 54636 | Greece |
| Novartis Investigative Site | Athens | GR | 124 62 | Greece |
| Novartis Investigative Site | Heraklion Crete | GR | 711 10 | Greece |
| Novartis Investigative Site | Larissa | GR | 411 10 | Greece |
| Novartis Investigative Site | Thessaloniki | GR | 546 29 | Greece |
| Novartis Investigative Site | Budapest | 1133 | Hungary |
| Novartis Investigative Site | Budapest | H-1083 | Hungary |
| Novartis Investigative Site | Debrecen | 4032 | Hungary |
| Novartis Investigative Site | Dublin | Ireland | Ireland |
| Novartis Investigative Site | Dublin | Ireland |
| Novartis Investigative Site | Bologna | BO | 40138 | Italy |
| Novartis Investigative Site | Florence | FI | 50134 | Italy |
| Novartis Investigative Site | Milan | MI | 20100 | Italy |
| Novartis Investigative Site | Milan | MI | 20132 | Italy |
| Novartis Investigative Site | Roma | RM | 00144 | Italy |
| Novartis Investigative Site | Torino | TO | 10122 | Italy |
| Novartis Investigative Site | Udine | 33100 | Italy |
| Novartis Investigative Site | Leiden 2333 ZA | Netherlands | 2333 | Netherlands |
| Novartis Investigative Site | Amsterdam | 1081 | Netherlands |
| Novartis Investigative Site | Nijmegen | 6525 GA | Netherlands |
| Novartis Investigative Site | Rotterdam | 3011 BH | Netherlands |
| Novartis Investigative Site | Tilburg | 5022 GC | Netherlands |
| Novartis Investigative Site | Bielsko-Biala | 43-300 | Poland |
| Novartis Investigative Site | Gdansk | 80-809 | Poland |
| Novartis Investigative Site | Krakow | 31-501 | Poland |
| Novartis Investigative Site | Lublin | 20-079 | Poland |
| Novartis Investigative Site | Warsaw | 02-005 | Poland |
| Novartis Investigative Site | Wroclaw | 50-556 | Poland |
| Novartis Investigative Site | Porto | Porto District | 4200-319 | Portugal |
| Novartis Investigative Site | Coimbra | Portugal | 3000-354 | Portugal |
| Novartis Investigative Site | Coimbra | Portugal | 3030-163 | Portugal |
| Novartis Investigative Site | Porto | Portugal | 4099-001 | Portugal |
| Novartis Investigative Site | Lisbon | 1050-085 | Portugal |
| Novartis Investigative Site | Lisbon | 1349-019 | Portugal |
| Novartis Investigative Site | Žilina | Slovak Republic | 010 01 | Slovakia |
| Novartis Investigative Site | Bratislava | Slovakia | 826 06 | Slovakia |
| Novartis Investigative Site | Banská Bystrica | 975 17 | Slovakia |
| Novartis Investigative Site | Bilbao | Basque Country | 48006 | Spain |
| Novartis Investigative Site | Valladolid | Castille and León | 47011 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08022 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | Spain |
| Novartis Investigative Site | L'Hospitalet de Llobregat | Catalonia | 08907 | Spain |
| Novartis Investigative Site | Santiago de Compostela | Galicia | 15706 | Spain |
| Novartis Investigative Site | Alicante | Valencia | 03016 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46014 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46015 | Spain |
| Novartis Investigative Site | Örebro | 701 85 | Sweden |
| Novartis Investigative Site | Zurich | Switzerland | 8063 | Switzerland |
| Novartis Investigative Site | Bern | 3012 | Switzerland |
| Novartis Investigative Site | Lausanne | 1007 | Switzerland |
| Novartis Investigative Site | Ankara | Turkey | 06100 | Turkey (Türkiye) |
| Novartis Investigative Site | Frimley | Surrey | GU16 7UJ | United Kingdom |
| Novartis Investigative Site | London | United Kingdom | EC1V 2PD | United Kingdom |
| Novartis Investigative Site | Belfast | BT12 6BA | United Kingdom |
| Novartis Investigative Site | Birmingham | B9 5SS | United Kingdom |
| Novartis Investigative Site | Bristol | BS1 2LX | United Kingdom |
| Novartis Investigative Site | Hull | HU3 2JZ | United Kingdom |
| Novartis Investigative Site | Liverpool | L69 3GA | United Kingdom |
| Novartis Investigative Site | London | NW1 5QH | United Kingdom |
| Novartis Investigative Site | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Novartis Investigative Site | Plymouth | PL4 6PL | United Kingdom |
| Novartis Investigative Site | Southampton | SO16 6YD | United Kingdom |
| Larsen M, Waldstein SM, Priglinger S, Hykin P, Barnes E, Gekkieva M, Das Gupta A, Wenzel A, Mones J; CRYSTAL Study Group. Sustained Benefits from Ranibizumab for Central Retinal Vein Occlusion with Macular Edema: 24-Month Results of the CRYSTAL Study. Ophthalmol Retina. 2018 Feb;2(2):134-142. doi: 10.1016/j.oret.2017.05.016. Epub 2017 Sep 9. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ranibizumab Arm | Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN |
| 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 | Mean Change in Best Corrected Visual Acuity (BCVA) at Month 12 Compared to Baseline | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement | The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. One patient was excluded from the FAS for not having ≥ 1 post-baseline study eye VA assessment. | Posted | Mean | Standard Deviation | Letters | Baseline to month 12 |
|
|
| |||||||||||||||||||||||||
| Secondary | Mean Change in Best Corrected Visual Acuity (BCVA) at Month 24 Compared to Baseline | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement | The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. One patient was excluded from the FAS for not having ≥ 1 post-baseline study eye VA assessment. | Posted | Mean | Standard Deviation | Letters | Baseline to Month 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Mean Average Change in Best Corrected Visual Acuity (BCVA From Baseline Month 12 and Month 24 | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 12 (or Month 24). Then, mean average change is calculated as the average of average changes across all patients. | The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. One patient was excluded from the FAS for not having ≥ 1 post-baseline study eye VA assessment. | Posted | Mean | Standard Deviation | letters | Baseline and Month 1 to 12 or Month 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Mean Average Change in BCVA From First Treatment Interruption (Due to BCVA Stabilization) to Month 12 and Month 24 | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. Stability in visual acuity after treatment interruption indicates longer duration of the drug efficacy | Full analysis set with use of LOCF consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. The number of patients shown was with a value at treatment interruption and an average for the post treatment interruption visits. | Posted | Mean | Standard Deviation | Letters | Month 12 and Month 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 and Month 24 in the Study Eye | 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 increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters of visual acuity at month 12 as compared with baseline | The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. No data were excluded from the FAS analyses because of protocol deviations. | Posted | Number | Letters | Month 12 and Month 24 |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 and Month 24 | Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at month 12 and month 24 indicates a positive outcome. | The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. No data were excluded from the FAS analyses because of protocol deviations. | Posted | Number | Letters | Month 12 and Month 24 |
|
| |||||||||||||||||||||||||||
| Secondary | Mean Change in Central Reading Center (CRC)-Assessed Central Subfield Thickness (CSFT) From Month 12 and Month 24 Compared to Baseline | Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation | The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. No data were excluded from the FAS analyses because of protocol deviations. | Posted | Mean | Standard Deviation | Microns | Baseline, Month 12 and Month 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Mean Change in Patient-reported Outcomes in NEI-VFQ-25 Composite and Subscale Scores at Month 12 and Month 24 Compared to Baseline | The survey consists of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranges from 0 (worst) to 100 which indicates the best possible response. The composite score and score of each of each construct also range from 0 to 100 as they are calculated as total scores divided by the number of questions. The higher the values of total scores represent better outcome. Scores per visit and of the change descriptively by visit. | The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. The number of patients shown was with a value for both baseline and the post-baseline visit. | Posted | Mean | Standard Deviation | Score on a scale | Month 12 and Month 24 |
|
|
Not provided
Not provided
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 0.5mg | Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN | 64 | 357 | 244 | 357 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Cataract (Fellow untreated eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Cataract (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Glaucoma (Fellow untreated eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Glaucoma (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Hyphaema (Fellow untreated eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Hyphaema (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Myopia (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Retinal haemorrhage (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Retinal ischaemia (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Retinal vascular thrombosis (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Visual acuity reduced (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vitreous haemorrhage (Fellow untreated eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vitreous haemorrhage (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Abdominal adhesions | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal polyp haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Death | General disorders | MedDRA | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Ophthalmic herpes zoster (Fellow untreated eye) | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Limb traumatic amputation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Scapula fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Intraocular pressure increased (Study eye) | Investigations | MedDRA | Systematic Assessment |
| |
| Visual acuity tests abnormal (Study eye) | Investigations | MedDRA | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Brain hypoxia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal mass | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Haemorrhagic ovarian cyst | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Aneurysm ruptured | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Angiopathy | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Diabetic vascular disorder | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Peripheral artery aneurysm | Vascular disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blepharitis (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Cataract (Fellow untreated eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Cataract (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Conjunctival haemorrhage (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Dry eye (Fellow untreated eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Dry eye (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eye pain (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eyelid oedema (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Glaucoma (Fellow untreated eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Glaucoma (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 |
| |
| Ocular hypertension (Fellow untreated eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Ocular hypertension (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 |
| |
| Vitreous detachment (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vitreous floaters (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Injection site pain (Study eye) | General disorders | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Conjunctivitis (Fellow untreated eye) | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Conjunctivitis (Study eye) | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Intraocular pressure increased (Fellow untreated eye) | Investigations | MedDRA | Systematic Assessment |
| |
| Intraocular pressure increased (Study eye) | Investigations | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cough | 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 | 862-778-8300 |
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| 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 |
Not provided
Not provided
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