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Study was terminated based on the results of analyses performed as planned at Month 12.
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This study will evaluate the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity compared to ranibizumab monotherapy and the durability of response observed in patients with choroidal neovascularization secondary to age-related macular degeneration
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verteporfin + Ranibizumab | Experimental | Verteporfin (6 mg/m^2) photodynamic therapy (PDT) and ranibizumab (0.5 mg). Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA). |
|
| Ranibizumab Monotherapy | Active Comparator | Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verteporfin Photodynamic Therapy | Drug | After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m^2 body surface area, verteporfin was activated by light application of 50 J/cm^2 to the study eye, begun 15 minutes after the start of the infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Best-corrected Visual Acuity (BCVA) at Month 12. | 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 increase in the VA score indicates improvement in visual acuity. | Baseline and Month 12 |
| Percent of Participants With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit | The number of patients with a ranibizumab treatment-free interval, ie, no active ranibizumab treatments for at least 3 months duration (at least 2 consecutive monthly visits), anytime following the Month 2 ranibizumab treatment. Only active ranibizumab treatments were considered. | Month 2 to Month 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12 | The proportion of patients with leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA). | Month 12 |
| Mean Change in Total Area of Leakage (Observed) of the Study Eye at Month 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative site | Vienna | Austria | ||||
| Novartis Investigative site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25079064 | Derived | Ritter M, Simader C, Bolz M, Deak GG, Mayr-Sponer U, Sayegh R, Kundi M, Schmidt-Erfurth UM. Intraretinal cysts are the most relevant prognostic biomarker in neovascular age-related macular degeneration independent of the therapeutic strategy. Br J Ophthalmol. 2014 Dec;98(12):1629-35. doi: 10.1136/bjophthalmol-2014-305186. Epub 2014 Jul 30. | |
| 22424834 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Verteporfin + Ranibizumab | Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
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Not provided
Not provided
|
| Ranibizumab | Drug | Ranibizumab 0.5 mg (0.05 mL of 10 mg/mL solution for injection) administered as an intravitreal injection |
|
|
| Placebo | Drug | As a placebo for verteporfin photodynamic therapy (for masking purposes), patients were administered a 10-minute intravenous infusion of 5% dextrose solution, followed by light application of 50 J/cm^2 to the study eye, begun 15 minutes after the start of infusion. |
|
Fluorescein angiography (FA) was used to assess the mean change of leakage of the study eye at the Central Reading Center (CRC). A negative change from baseline indicates improvement, ie, less leakage. |
| Baseline and Month 12 |
| Mean Change in Central Retinal Thickness of the Study Eye at Month 12 | Optical coherence tomography (OCT) was used to assess the mean change in retinal thickness of the study eye at the Central Reading Center (CRC). A negative change from baseline indicates improvement, ie, less thickness. | Baseline and Month 12 |
| Antwerp |
| Belgium |
| Novartis Investigative site | Aalborg | Denmark |
| Novartis Investigative site | Créteil | France |
| Novartis Investigative site | Regensburg | Germany |
| Novartis Investigative site | Budapest | Hungary |
| Novartis Investigative site | Florence | Italy |
| Novartis Investigative site | Rotterdam | Netherlands |
| Novartis Investigative site | Warsaw | Poland |
| Novartis Investigative site | Madrid | Spain |
| Novartis Investigative site | Geneva | Switzerland |
| Novartis Investigative site | Manchester | United Kingdom |
| Larsen M, Schmidt-Erfurth U, Lanzetta P, Wolf S, Simader C, Tokaji E, Pilz S, Weisberger A; MONT BLANC Study Group. Verteporfin plus ranibizumab for choroidal neovascularization in age-related macular degeneration: twelve-month MONT BLANC study results. Ophthalmology. 2012 May;119(5):992-1000. doi: 10.1016/j.ophtha.2012.02.002. Epub 2012 Mar 17. |
| FG001 | Ranibizumab | Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA). |
| Completed 12 Month Phase |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Verteporfin + Ranibizumab | Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA). |
| BG001 | Ranibizumab | Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA). |
| 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 | Change From Baseline in Best-corrected Visual Acuity (BCVA) at Month 12. | 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 increase in the VA score indicates improvement in visual acuity. | Performed on the Full analysis set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. FAS consisted of all patients as randomized that received at least one application of study drug and had at least one post-baseline assessment for best corrected visual acuity in the study eye. | Posted | Mean | Standard Deviation | Letters | Baseline and Month 12 |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Percent of Participants With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit | The number of patients with a ranibizumab treatment-free interval, ie, no active ranibizumab treatments for at least 3 months duration (at least 2 consecutive monthly visits), anytime following the Month 2 ranibizumab treatment. Only active ranibizumab treatments were considered. | Full analysis set. Includes number of participants in the treatment group with at least one visit assessment of re-treatment. | Posted | Number | Percentage of Participants | Month 2 to Month 11 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12 | The proportion of patients with leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA). | The Full Analysis Set (FAS) based on observed data. | Posted | Number | Percentage of participants | Month 12 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in Total Area of Leakage (Observed) of the Study Eye at Month 12 | Fluorescein angiography (FA) was used to assess the mean change of leakage of the study eye at the Central Reading Center (CRC). A negative change from baseline indicates improvement, ie, less leakage. | Full analysis set based on observed data. | Posted | Mean | Standard Deviation | mm^2 | Baseline and Month 12 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in Central Retinal Thickness of the Study Eye at Month 12 | Optical coherence tomography (OCT) was used to assess the mean change in retinal thickness of the study eye at the Central Reading Center (CRC). A negative change from baseline indicates improvement, ie, less thickness. | Full analysis set, LOCF | Posted | Mean | Standard Deviation | μm | Baseline and Month 12 |
|
Includes cumulative data through 24 months.
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 | Verteporfin + Ranibizumab | Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA). | 25 | 122 | 64 | 122 | ||
| EG001 | Ranibizumab | Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA). | 28 | 133 | 63 | 133 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANGINA PECTORIS | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| ARRHYTHMIA | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CARDIAC VALVE DISEASE | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CATARACT (Fellow eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| CATARACT (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| CHORIORETINAL ATROPHY (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| GLAUCOMA (Fellow eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| GLAUCOMA (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| LAGOPHTHALMOS (Fellow eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| PARALYTIC LAGOPHTHALMOS (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| RETINAL ARTERY OCCLUSION (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| RETINAL CYST (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| RETINAL DEGENERATION (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| RETINAL OEDEMA (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| ULCERATIVE KERATITIS (Fellow eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| VISUAL ACUITY REDUCED (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| HIATUS HERNIA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| SALIVARY GLAND CALCULUS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| VISCEROPTOSIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA | Systematic Assessment |
| |
| BILE DUCT STENOSIS | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| BILE DUCT STONE | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| LABYRINTHITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| MASTOIDITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA | Systematic Assessment |
| |
| SIALOADENITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| WOUND INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| CARTILAGE INJURY | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| HEAD INJURY | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| JOINT DISLOCATION | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| LUMBAR VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| MULTIPLE INJURIES | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| CARBOHYDRATE ANTIGEN 125 INCREASED | Investigations | MedDRA | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| OSTEOPOROSIS | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| BLADDER NEOPLASM | 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 |
| |
| GENITAL NEOPLASM MALIGNANT FEMALE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| MEDIASTINUM NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| METASTASES TO PERITONEUM | 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 NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| SKIN CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| CAROTID ARTERY STENOSIS | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| CEREBRAL ISCHAEMIA | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| FACIAL PARESIS | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| AORTIC ANEURYSM | Vascular disorders | MedDRA | Systematic Assessment |
| |
| ARTERIAL STENOSIS LIMB | Vascular disorders | MedDRA | Systematic Assessment |
| |
| ARTERIAL THROMBOSIS LIMB | Vascular disorders | MedDRA | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA | Systematic Assessment |
| |
| ILIAC ARTERY OCCLUSION | Vascular disorders | MedDRA | Systematic Assessment |
| |
| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA | Systematic Assessment |
| |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | MedDRA | Systematic Assessment |
| |
| THROMBOSIS | Vascular disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONJUNCTIVAL HAEMORRHAGE (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| EYE PAIN (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| MACULAR DEGENERATION (Fellow eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| OCULAR HYPERAEMIA (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| RETINAL HAEMORRHAGE (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| INTRAOCULAR PRESSURE INCREASED (Study eye) | Investigations | MedDRA | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862 778-8300 |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077362 | Verteporfin |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D011166 | Porphyrins |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| 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
| Male |
|
| Change from Baseline |
|
|
|
|
|
|
|
|
|