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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number: 2008-003550-15 |
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The study will assess the safety and efficacy of Everolimus (RAD001) alone or in combination with Lucentis in patients with neo-vascular age related macular degeneration (AMD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Everolimus 5 mg | Experimental | 5 mg orally once daily plus sham ocular injection on Day 1 (Baseline) until Day 28 |
|
| Ranibizumab 0.5 mg | Active Comparator | Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (baseline) |
|
| Oral Everolimus (5mg) and Ranibizumab (0.5mg) | Active Comparator | Everolimus orally 5 mg once daily plus Ranibizumab Intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus | Drug | 5 mg oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Central Retinal Thickness From Baseline to Week 4, as Measured by Optical Coherence Tomography (OCT) | Central retinal thickness was assessed by Optical coherence tomography (OCT). The primary thickness endpoint was the mean thickness of the foveal field of the macula map produced by the analysis of the sequence of six radial scans. Foveal field thickness was the average thickness of a circular field with a diameter of 1 mm. OCT images were analyzed by a central reading center. | Baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Acuity From Baseline to Week 4 in Patients Treated With Everolimus | Best corrected visual acuity (BCVA) was assessed on both eyes. BCVA measurements were taken in sitting position using Early Treatment Diabetic Retinopathy Study (ETDRs)-like visual acuity testing charts at an initial testing distance specific to test charts. BCVA is measured from the number of letters the patient can read on the eye chart. |
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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 |
|---|---|---|---|---|---|---|
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | 90211 | United States | ||
| Retinal Consultants Medical Group, Inc. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Everolimus 5 mg | 5 mg orally once daily plus sham ocular injection on Day 1 (Baseline) |
| FG001 | Ranibizumab 0.5 mg | Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (baseline) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Ranibizumab | Drug | 0.5 mg administered by intravitreal injection |
|
| Baseline and week 4 |
| Sacramento |
| California |
| United States |
| Porter Adventist Hospital, Diagnostic Eye Laboratory | Denver | Colorado | 80210 | United States |
| Discover Vision Center | Independence | Missouri | 64055 | United States |
| Novartis Investigative Site | Bristol | United Kingdom |
| Novartis Investigative Site | Frimley | United Kingdom |
| Novartis Investigative Site | Liverpool | United Kingdom |
| Novartis Investigative Site | London | United Kingdom |
| Novartis Investigative Site | Oxford | United Kingdom |
| Novartis Investigative site | Portsmouth | United Kingdom |
| Novartis Investigative Site | Southampton | United Kingdom |
| Novartis Investigator Site | Wolverhampton | United Kingdom |
| FG002 | Everolimus and Ranibizumab | Everolimus oral 5 mg once daily plus ranibizumab Intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline) |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Everolimus 5 mg | 5 mg orally once daily plus sham ocular injection on Day 1 (Baseline) |
| BG001 | Ranibizumab 0.5 mg | Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (baseline) |
| BG002 | Everolimus and Ranibizumab | Everolimus oral 5 mg once daily plus ranibizumab Intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline) |
| 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 |
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| 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 in Central Retinal Thickness From Baseline to Week 4, as Measured by Optical Coherence Tomography (OCT) | Central retinal thickness was assessed by Optical coherence tomography (OCT). The primary thickness endpoint was the mean thickness of the foveal field of the macula map produced by the analysis of the sequence of six radial scans. Foveal field thickness was the average thickness of a circular field with a diameter of 1 mm. OCT images were analyzed by a central reading center. | The Per Protocol Analysis Set (PPAS)consisted of all patients in the Full Analysis Set (FAS)who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and had non-missing central retinal thickness values for the study eye at both baseline and Day 28. | Posted | Mean | Standard Deviation | µm | Baseline and 4 weeks |
|
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| |||||||||||||||||||||||||||||||||
| Secondary | Change in Visual Acuity From Baseline to Week 4 in Patients Treated With Everolimus | Best corrected visual acuity (BCVA) was assessed on both eyes. BCVA measurements were taken in sitting position using Early Treatment Diabetic Retinopathy Study (ETDRs)-like visual acuity testing charts at an initial testing distance specific to test charts. BCVA is measured from the number of letters the patient can read on the eye chart. | The Per Protocol Analysis Set (PPAS)consisted of all patients in the Full Analysis Set (FAS)who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and had non-missing central retinal thickness values for the study eye at both baseline and Day 28. | Posted | Mean | Standard Deviation | Letters | Baseline and week 4 |
|
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Only two arms are represented in the Serious Adverse Events and Adverse Events > 5% Tables. The Ranibizumab 0.5 mg IVT arm is omitted because there were no SAEs or AEs reported in that treatment group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Everolimus 5 mg | 5 mg once daily plus sham ocular injection on Day 1 (Baseline) | 0 | 8 | 6 | 8 | ||
| EG001 | Everolimus 5 mg and Ranibizumab 0.5 mg | Everolimus orally 5 mg once daily plus Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline) | 0 | 7 | 5 | 7 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lacrimation increased | Eye disorders | MedDRA | Systematic Assessment |
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| Macular degeneration | Eye disorders | MedDRA | Systematic Assessment |
| |
| Optic disc haemorrhage | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Tongue ulceration | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
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| Furuncle | Infections and infestations | MedDRA | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
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| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Blood cholesterol increased | Investigations | MedDRA | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA | Systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA | Systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Aortic wall hypertrophy | Vascular disorders | MedDRA | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
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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 the trial results in their entirety.
| 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 |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| 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 |
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| Male |
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| Change from Baseline |
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