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To evaluate, specifically within the Canadian medical environment, the efficacy, safety and cost-efficacy of ranibizumab administered either as combination therapy (ranibizumab plus laser photocoagulation), or as monotherapy in comparison with the current standard of care (laser photocoagulation monotherapy), in patients with visual impairment due to DME.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Therapy | Experimental | Participants received ranibizumab intravitreal injection and laser photocoagulation treatments |
|
| Ranibizumab Monotherapy | Experimental | Participants received ranibizumab intravitreal injection therapy only |
|
| Laser Monotherapy | Active Comparator | Participants received Laser photocoagulation therapy only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab | Drug | Ranibizumab 0.5 mg fixed loading dose via intravitreal injection, given once per month for 3 consecutive months (Day 1, Month 1 and Month 2). This treatment could be reapllied, depending on symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Best Corrected Visual Acuity- (BCVA) 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 BCVA (EDTRS) is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement. | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Months 3,6 and 9 | 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 BCVA (EDTRS)is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Calgary Retina Consultants | Calgary | Alberta | Canada | |||
| UBC - Eye Care Center |
3 treatment arms: Group C - laser photocoagulation per ETDRS guidelines, Group B - ranibizumab intravitreal injections (3 monthly injections during loading phase, and subsequent treatments per protocol-defined criteria), or Group A - combination therapy, where decisions to treat with laser were independent of decisions to treat with ranibizumab.
A total of 239 patients were enrolled in the study. An additional 2 patients were enrolled but were removed from the database because consent was not signed in accordance with GCP principles."
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| ID | Title | Description |
|---|---|---|
| FG000 | Combination Therapy | Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments. |
| FG001 | Ranibizumab Monotherapy | Participants received ranibizumab intravitreal injection therapy only |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Laser | Procedure | Laser photocoagulation treatment was administered on Day 1. Subsequent laser treatments could be administered if needed, in accordance with Early Treatment Diabetic Retinopathy Study (ETDRS) guidelines. |
|
| Baseline, 3, 6 and 9 months |
| Change From Baseline in Central Retinal Thickness (CRT) at Months 3,6,9 and 12 | OCT is a diagnostic imaging technique using low-coherence interferometry to produce cross-sectional tomograms of the posterior segment eye structures. OCT was performed prior to study treatment to assess CRT, presence of fluid in the macula (intra-retinal cyst or fluid) and evaluation of image to monitor disease progression/treatment effect and to determine the need to stop/re-initiate ranibizumab treatment | Baseline, 3, 6, 9 and 12 months |
| Percentage of Patients Achieving a Gain of 15-letters or More (3-lines) in BCVA From 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 BCVA (EDTRS) is 0 to 100 letters. A higher percent of patients achieving a gain of ≥15 letters BCVA indicates a better response. | Baseline, 3, 6, 9 and 12 months |
| Percentage of Patients Achieving Gain of Letters From Baseline in BCVA | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of BCVA (EDTRS) is 0 to 100 letters. A gain of 5,10,15 or more BCVA letters from baseline indicates improvement. | 12 months |
| National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) Composite Score at Month 12 | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure the influence of visual disability and visual symptoms on general health domains. 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. For each question, the patient was asked to rate their condition on a scale of 1-5 or 1-6, where a low number reflects a better outcome. A composite score for a patient is calculated by aggregating and averaging the scores from the 11 sub-scales (excluding general health sub-scale), and an algorithm is apply to give equal weight to each sub-scale. Sub-scales and composite scores are calculated by converting the response from questionnaires into a 0-100 scale, with 0 as the worst possible outcome and 100 as the best. Missing data was not imputed | 12 month |
| EuroQoL (EQ-5D) Utility Score at Month 12 | The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to 5 dimensions, namely: mobility, self-care, usual activities, pain-discomfort, and anxiety/depression. The possible range for each dimension was 1 to 3, where 1="no problems", 2="some problems" and 3="extreme problems". Missing values were not imputed. Using the scoring algorithm derived from the Canadian value sets (Bansback et al., 2012), a utility score for a patient was calculated based on the EQ-5D responses for a given time-point at which the questionnaire was presented to the patient. This mean EQ-5D utility score ranged between 0 (worst health) to 1 (perfect health). | 12 month |
| Time Trade-Off Questionnaire - 25 (TTO) Composite Score at Month 12 | (TTO) questionnaire was used to help determine the patients' health utility. Reported health utility represents the patients' quality of life at the current health state, and is a cardinal value that ranges from 0 (worst possible health or death) to 1 (best possible health). In this questionnaire, patients were first asked to estimate their remaining life expectancy. Second, the patients were presented with a hypothetical situation where a technology existed that could permanently return their vision to normal. This technology would always work, but would decrease their length of survival. Patients were then asked how much of their remaining life expectancy, if any, they would be willing to trade in return for use of the technology and thus for normal vision. The principle of this measure is that if patients were content with their current vision status (i.e., have a utility value of 1.0), they would not want to trade any of their remaining life years to improve their vision. | 12 month |
| Vancouver |
| British Columbia |
| Canada |
| Retina Consultants of Victoria | Victoria | British Columbia | Canada |
| Memorial University Health Sciences Centre / Bense Eye Centre | St. John's | Newfoundland and Labrador | Canada |
| Victoria General Hospital, Department of Ophthalmology | Halifax | Nova Scotia | Canada |
| Ivey Eye Institute | London | Ontario | Canada |
| Canadian Centre for Advanced Eye Therapeutics | Mississauga | Ontario | Canada |
| The Ottawa Hospital - General Campus | Ottawa | Ontario | Canada |
| St-Michael's Hospital - Dept of Ophthalmology | Toronto | Ontario | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada |
| Toronto Western Hospital | Toronto | Ontario | Canada |
| Clinique ChirurgiVision | Drummondville | Quebec | Canada |
| Hôpital Maisonneuve-Rosemont | Montreal | Quebec | Canada |
| Hôpital Notre Dame (CHUM) | Montreal | Quebec | Canada |
| Royal Victoria Hospital | Montreal | Quebec | Canada |
| Centre Oculaire de Québec | Québec | Quebec | Canada |
| Dr.Michel Giunta Clinique Médicale | Sherbrooke | Quebec | Canada |
| Saskatoon City Hospital / Spadina Clinic | Saskatoon | Saskatchewan | Canada |
| Institut de l'oeil des Laurentides | Québec | Canada |
| Memorial University Health Sciences Centre / Newfoundland Drive Medical Clinic | St. John's | Canada |
| FG002 | Laser Monotherapy | Participants received Laser photocoagulation therapy only |
| Intent to Treat (ITT) Population |
|
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Intent to Treat (ITT) population was defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from a center were excluded from ITT.
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| ID | Title | Description |
|---|---|---|
| BG000 | Combination Therapy | Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments. |
| BG001 | Ranibizumab Monotherapy | Participants received ranibizumab intravitreal injection therapy only |
| BG002 | Laser Monotherapy | Participants received Laser photocoagulation therapy only |
| 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 | Mean Change From Baseline in Best Corrected Visual Acuity- (BCVA) 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 BCVA (EDTRS) is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement. | ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. patients with both baseline and 12 month data were included. | Posted | Mean | Standard Deviation | Letters | Baseline and 12 months |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Months 3,6 and 9 | 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 BCVA (EDTRS)is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement. | The ITT population was defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one site were excluded from ITT. | Posted | Mean | Standard Deviation | Letters | Baseline, 3, 6 and 9 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Central Retinal Thickness (CRT) at Months 3,6,9 and 12 | OCT is a diagnostic imaging technique using low-coherence interferometry to produce cross-sectional tomograms of the posterior segment eye structures. OCT was performed prior to study treatment to assess CRT, presence of fluid in the macula (intra-retinal cyst or fluid) and evaluation of image to monitor disease progression/treatment effect and to determine the need to stop/re-initiate ranibizumab treatment | The ITT population was defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one site were excluded from ITT. | Posted | Mean | Standard Deviation | um | Baseline, 3, 6, 9 and 12 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Achieving a Gain of 15-letters or More (3-lines) in BCVA From 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 BCVA (EDTRS) is 0 to 100 letters. A higher percent of patients achieving a gain of ≥15 letters BCVA indicates a better response. | The ITT population was defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one site were excluded from ITT | Posted | Number | Percentage of Patients | Baseline, 3, 6, 9 and 12 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Achieving Gain of Letters From Baseline in BCVA | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of BCVA (EDTRS) is 0 to 100 letters. A gain of 5,10,15 or more BCVA letters from baseline indicates improvement. | ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. Patients with 12 month data were included | Posted | Number | Percentage of Patients | 12 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) Composite Score at Month 12 | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure the influence of visual disability and visual symptoms on general health domains. 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. For each question, the patient was asked to rate their condition on a scale of 1-5 or 1-6, where a low number reflects a better outcome. A composite score for a patient is calculated by aggregating and averaging the scores from the 11 sub-scales (excluding general health sub-scale), and an algorithm is apply to give equal weight to each sub-scale. Sub-scales and composite scores are calculated by converting the response from questionnaires into a 0-100 scale, with 0 as the worst possible outcome and 100 as the best. Missing data was not imputed | ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. Patients with both baseline and 12 month data were included | Posted | Mean | Standard Deviation | Units on a Scale | 12 month |
| |||||||||||||||||||||||||||||||||
| Secondary | EuroQoL (EQ-5D) Utility Score at Month 12 | The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to 5 dimensions, namely: mobility, self-care, usual activities, pain-discomfort, and anxiety/depression. The possible range for each dimension was 1 to 3, where 1="no problems", 2="some problems" and 3="extreme problems". Missing values were not imputed. Using the scoring algorithm derived from the Canadian value sets (Bansback et al., 2012), a utility score for a patient was calculated based on the EQ-5D responses for a given time-point at which the questionnaire was presented to the patient. This mean EQ-5D utility score ranged between 0 (worst health) to 1 (perfect health). | ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. Patients with both baseline and 12 month data were included | Posted | Mean | Standard Deviation | Units on a scale | 12 month |
| |||||||||||||||||||||||||||||||||
| Secondary | Time Trade-Off Questionnaire - 25 (TTO) Composite Score at Month 12 | (TTO) questionnaire was used to help determine the patients' health utility. Reported health utility represents the patients' quality of life at the current health state, and is a cardinal value that ranges from 0 (worst possible health or death) to 1 (best possible health). In this questionnaire, patients were first asked to estimate their remaining life expectancy. Second, the patients were presented with a hypothetical situation where a technology existed that could permanently return their vision to normal. This technology would always work, but would decrease their length of survival. Patients were then asked how much of their remaining life expectancy, if any, they would be willing to trade in return for use of the technology and thus for normal vision. The principle of this measure is that if patients were content with their current vision status (i.e., have a utility value of 1.0), they would not want to trade any of their remaining life years to improve their vision. | ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. Patients with both baseline and 12 month data were included | Posted | Mean | Standard Deviation | Units on a scale | 12 month |
|
Not provided
The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site
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 | Combination Therapy | Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments. | 9 | 73 | 26 | 73 | ||
| EG001 | Ranibizumab Monotherapy | Participants received ranibizumab intravitreal injection therapy only | 10 | 75 | 26 | 75 | ||
| EG002 | Laser Monotherapy | Participants received Laser photocoagulation therapy only | 5 | 74 | 17 | 74 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Vitreous haemorrhage (Fellow eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vitreous haemorrhage (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA | Systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Diabetic foot infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Endometrial cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Neurogenic bladder | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract (Fellow eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Cataract (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Conjunctival haemorrhage (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eye irritation (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vision blurred (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vitreous haemorrhage (Fellow eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vitreous haemorrhage (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Intraocular pressure increased (Fellow eye) | Investigations | MedDRA | Systematic Assessment |
| |
| Intraocular pressure increased (Study eye) | Investigations | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system 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 publication of the pooled data (i.e. data from all sites) in the clinical trial or dislcosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D003920 | Diabetes Mellitus |
| D008269 | Macular Edema |
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| D007834 | Lasers |
| 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 |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
Not provided
Not provided
| Male |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Ranibizumab Monotherapy |
Participants received ranibizumab intravitreal injection therapy only |
| OG002 | Laser Monotherapy | Participants received Laser photocoagulation therapy only |
|
|
| OG002 | Laser Monotherapy | Participants received Laser photocoagulation therapy only |
|
|
| OG001 |
| Ranibizumab Monotherapy |
Participants received ranibizumab intravitreal injection therapy only |
| OG002 | Laser Monotherapy | Participants received Laser photocoagulation therapy only |
|
|