Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study was designed to confirm the efficacy and safety of ranibizumab (0.5 mg) as adjunctive therapy when added to laser photocoagulation and/or as monotherapy in Asian patients with visual impairment due to Diabetic Macular Edema (DME).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjunctive treatment | Experimental | Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser. |
|
| Monotherapy treatment | Experimental | Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser. |
|
| Laser control | Active Comparator | Active laser treatment plus sham intravitreal injections. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | Ranibizumab 0.5 mg intravitreal injection at day 1, month 1 and month 2. If stable vision not reached at month 3, one injection per month continued until stable vision was reached. Intravitreal injections re-initiated if needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Change From Baseline of Best-Corrected Visual Acuity (BCVA) Over 12 Months (From Month 1 to Month 12 Compared to Baseline) | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline on Central Retinal Subfield Thickness (CRST) at Month 12 | Central Retinal Subfield Thickness (CRST) was measured using Optical Coherence Tomography (OCT) in micrometers. A negative change from baseline of CRST indicates improvement. | 12 months |
| Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline |
Not provided
Inclusion Criteria:
Patients with Type 1 or Type 2 diabetes mellitus according to American Diabetes Association (ADA) or World Health Organization (WHO) guidelines with HbA1c not more than 10.0% at screening (Visit 1). Patients should be on diet, exercise, and/or pharmacological treatment for diabetes.
Patients with visual impairment due to focal or diffuse Diabetic Macular Edema in at least one eye who are eligible for laser treatment in the opinion of the investigator. If both eyes are eligible, the one with the worse visual acuity, as assessed at Visit 1, will be selected for study treatment unless, based on medical reasons, the investigator deems the other eye the more appropriate candidate for study treatment.
The study eye must fulfill the following criteria at Visit 1:
Exclusion Criteria:
Ocular concomitant conditions/ diseases:
Ocular treatments:
Systemic conditions or treatments:
Compliance/ Administrative:
Other protocol-defined inclusion/exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Beijing | China | ||||
| Novartis Investigative Site |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Adjunctive Treatment | Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser. |
| FG001 | Monotherapy Treatment | Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Laser photocoagulation | Procedure | Active laser treatment administered at day 1. Subsequent laser treatments administered if needed at intervals no shorter than 3 months from previous laser treatment. |
|
| Sham ranibizumab | Drug | Sham intravitreal injections to ranibizumab at day 1, month 1 and month 2. Intravitreal injections re-initiated if needed. |
|
| Sham laser photocoagulation | Procedure | Sham laser treatment administered at day 1. |
|
Presence or absence of intra-retinal cysts in any of the 6 sections of the study eye was measured using Optical Coherence Tomography (OCT). A complete resolution or decrease from baseline of intra-retinal cysts indicates improvement. |
| Up to 12 months |
| Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline | Presence or absence of sub-retinal fluid in any of the 6 sections of the study eye was measured using Optical Coherence Tomography (OCT). A complete resolution or decrease from baseline of sub-retinal fluid indicates improvement. | Up to 12 months |
| Percent of Participants With Visual Acuity Above 73 Letters at Month 12 | 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 indicates a positive outcome. | 12 months |
| Percent of Participants Who Gained >= 10 Letters at Month 12 Compared to Baseline | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A gain of 10 or more BCVA letters from baseline indicates improvement. A BCVA of 84 letters or more at Month 12 indicates improvement. | 12 months |
| Percent of Participants Who Lost >= 10 Letters at Month 12 Compared to Baseline | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A loss of 10 or more BCVA letters from baseline indicates worsening. | 12 months |
| Percent of Participants Who Gained >= 15 Letters at Month 12 Compared to Baseline | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A gain of 15 or more BCVA letters from baseline indicates improvement. A BCVA of 84 letters or more at Month 12 indicates improvement. | 12 months |
| Percent of Participants Who Lost >= 15 Letters at Month 12 Compared to Baseline | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A loss of 15 or more BCVA letters from baseline indicates worsening. | 12 months |
| Best-Corrected Visual Acuity (BCVA) Mean Change From Baseline at Month 12 | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement. | 12 months |
| Patient Outcome Measure Euro Quality of Life Questionnaire (EQ-5D) | 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). | 12 months |
| Changsha |
| China |
| Novartis Investigative Site | Chengdu | China |
| Novartis Investigative Site | Chongqing | China |
| Novartis Investigative Site | Guangzhou | China |
| Novartis Investigative Site | Hangzhou | China |
| Novartis Investigational Site | Shanghai | China |
| Novartis Investigative Site | Wenzhou | China |
| Novartis Investigative Site | Xi'an | China |
| Novartis Investigative Site | Hong Kong | Hong Kong |
| Novartis Investigative Site | Chiba | Japan |
| Novartis Investigative Site | Chiyoda-ku | Japan |
| Novartis Investigative Site | Chūōku | Japan |
| Novartis Investigative Site | Fukuoka | Japan |
| Novartis Investigative Site | Fukushima | Japan |
| Novartis Investigative Site | Hirakata | Japan |
| Novartis Investigative Site | Kita-gun | Japan |
| Novartis Investigative Site | Kobe | Japan |
| Novartis Investigative Site | Kyoto | Japan |
| Novartis Investigative Site | Mitaka | Japan |
| Novartis Investigative Site | Nagoya | Japan |
| Novartis Investigative Site | Osaka | Japan |
| Novartis Investigative Site | Ōtsu | Japan |
| Novartis Investigative Site | Shimotsuke | Japan |
| Novartis Investigative Site | Shinjuku-ku | Japan |
| Novartis Investigative Site | Suita | Japan |
| Novartis Investigative Site | Toyko | Japan |
| Novartis Investigative Site | Urayasu | Japan |
| Novartis Investigative Site | Wakayama | Japan |
| Novartis Investigative Site | Yamagata | Japan |
| Novartis Investigative Site | Singapore | Singapore |
| Novartis Investigative Site | Seoul | South Korea |
| Novartis Investigative Site | Kaohsiung City | Taiwan |
| Novartis Investigative Site | Linkou District | Taiwan |
| Novartis Investigative Site | Taipei | Taiwan |
| FG002 | Laser Control | Active laser treatment plus sham intravitreal injections. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Adjunctive Treatment | Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser. |
| BG001 | Monotherapy Treatment | Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser. |
| BG002 | Laser Control | Active laser treatment plus sham intravitreal injections. |
| BG003 | 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 | Average Change From Baseline of Best-Corrected Visual Acuity (BCVA) Over 12 Months (From Month 1 to Month 12 Compared to Baseline) | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement. | The Full Analysis Set (FAS) consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had at least one post-baseline assessment for Best-Corrected Visual Acuity. | Posted | Mean | Standard Deviation | Letters | 12 months |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline on Central Retinal Subfield Thickness (CRST) at Month 12 | Central Retinal Subfield Thickness (CRST) was measured using Optical Coherence Tomography (OCT) in micrometers. A negative change from baseline of CRST indicates improvement. | The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had Central Retinal Subfield Thickness value with signal strength ≥ 5 for Carl Zeiss Optical Coherence Tomography 3 system. | Posted | Mean | Standard Deviation | micrometers | 12 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline | Presence or absence of intra-retinal cysts in any of the 6 sections of the study eye was measured using Optical Coherence Tomography (OCT). A complete resolution or decrease from baseline of intra-retinal cysts indicates improvement. | The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had intra-retinal cysts in any of the 6 sections of the study eye at baseline - not applicable means there was no intra-retinal cyst at baseline. | Posted | Number | percentage of participants | Up to 12 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline | Presence or absence of sub-retinal fluid in any of the 6 sections of the study eye was measured using Optical Coherence Tomography (OCT). A complete resolution or decrease from baseline of sub-retinal fluid indicates improvement. | The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had sub-retinal fluid in any of the 6 sections of the study eye at baseline. Not applicable means there was no sub-retinal fluid at baseline. | Posted | Number | percentage of participants | Up to 12 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percent of Participants With Visual Acuity Above 73 Letters at Month 12 | 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 indicates a positive outcome. | The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity. | Posted | Number | percentage of participants | 12 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percent of Participants Who Gained >= 10 Letters at Month 12 Compared to Baseline | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A gain of 10 or more BCVA letters from baseline indicates improvement. A BCVA of 84 letters or more at Month 12 indicates improvement. | The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity. | Posted | Number | Percentage of participants | 12 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percent of Participants Who Lost >= 10 Letters at Month 12 Compared to Baseline | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A loss of 10 or more BCVA letters from baseline indicates worsening. | The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity. | Posted | Number | Percentage of participants | 12 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percent of Participants Who Gained >= 15 Letters at Month 12 Compared to Baseline | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A gain of 15 or more BCVA letters from baseline indicates improvement. A BCVA of 84 letters or more at Month 12 indicates improvement. | The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity. | Posted | Number | Percentage of participants | 12 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percent of Participants Who Lost >= 15 Letters at Month 12 Compared to Baseline | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A loss of 15 or more BCVA letters from baseline indicates worsening. | The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity. | Posted | Number | Percentage of participants | 12 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Best-Corrected Visual Acuity (BCVA) Mean Change From Baseline at Month 12 | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement. | The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity. | Posted | Mean | Standard Deviation | Letters | 12 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Patient Outcome Measure Euro Quality of Life Questionnaire (EQ-5D) | 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). | The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had at least one post-baseline assessment for Best-Corrected Visual Acuity. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
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 | Monotherapy Treatment | Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser. | 21 | 133 | 36 | 133 | ||
| EG001 | Adjunctive Treatment | Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser. | 22 | 132 | 36 | 132 | ||
| EG002 | Laser Control | Active laser treatment plus sham intravitreal injections. | 19 | 128 | 23 | 128 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nephrogenic anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Cataract (Fellow eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Cataract (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Diabetic retinal oedema (Fellow eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Diabetic retinopathy (Fellow eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Maculopathy (Fellow eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Retinal detachment (Fellow eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Retinal detachment (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Retinal haemorrhage (Fellow eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vitreous haemorrhage (Fellow eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vitreous haemorrhage (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Epulis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Polyp colorectal | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Conjunctivitis bacterial (Study eye) | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Diabetic gangrene | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Endophthalmitis (Study eye) | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tuberculous pleurisy | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Bile duct cancer | 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 |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Diabetic neuropathy (Study eye) | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Spondylitic myelopathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Diabetic nephropathy | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary bladder polyp | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Diabetic retinal oedema (Fellow eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 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 | 41 61 324 1111 |
| ID | Term |
|---|---|
| D004487 | Edema |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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
| Male |
|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|