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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018852-29 | EudraCT Number |
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European drug approval.
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This study was designed to confirm the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in patients with visual impairment due to Diabetic Macular Edema. A subgroup of patients with Proliferative Diabetic Retinopathy were included to evaluate the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active laser photocoagulation and ranibizumab | Experimental | Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment. Ranibizumab intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment. |
|
| Active laser photocoagulation and sham injection | Active Comparator | Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment. Sham intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active laser photocoagulation | Procedure | Active laser photocoagulation procedure at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12 | Mean change in Best-Corrected Visual Acuity (BCVA) letters at 12 months compared to baseline was measured using Visual acuity (VA). VA accounts for the number of letters a participant can see using Early Treatment Diabetic Retinopathy Study (EDTRS)-like visual acuity testing charts, from a sitting position at a testing distance of 4 meters. BCVA means that the participant's refraction is already taken into account when VA is determined. A higher BCVA number at 12 months in reference to baseline indicates improved BCVA. | 12 months |
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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 |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Aschaffenburg | Germany | ||||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Click here for more information about this study: | View source |
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Participants did not complete study due to early termination. Study was terminated because of drug approval.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Laser Photocoagulation and Ranibizumab | Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment. Ranibizumab intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Sham injections | Drug | Sham intravitreal injections at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment. |
|
| Ranibizumab 0.5 mg | Drug | Ranibizumab 0.5 mg/0.05 ml intravitreal injection at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment. |
|
| Berlin |
| Germany |
| Novartis Investigative Site | Bonn | Germany |
| Novartis Investigative Site | Bremen | Germany |
| Novartis Investigative Site | Chemnitz | Germany |
| Novartis Investigative Site | Cologne | Germany |
| Novartis Investigative Site | Darmstadt | Germany |
| Novartis Investigative Site | Dessau | Germany |
| Novartis Investigative Site | Dortmund | Germany |
| Novartis Investigative Site | Dresden | Germany |
| Novartis Investigative Site | Eichstätt | Germany |
| Novartis Investigative Site | Essen | Germany |
| Novartis Investigative Site | Frankfurt | Germany |
| Novartis Investigative Site | Freiburg im Breisgau | Germany |
| Novartis Investigative Site | Giessen | Germany |
| Novartis Investigative Site | Hamburg | Germany |
| Novartis Investigative Site | Heidelberg | Germany |
| Novartis Investigative Site | Karlsruhe | Germany |
| Novartis Investigative Site | Kiel | Germany |
| Novartis Investigative Site | Landshut | Germany |
| Novartis Investigative Site | Leipzig | Germany |
| Novartis Investigative Site | Marburg | Germany |
| Novartis Investigative Site | Mühlheim | Germany |
| Novartis Investigative Site | München | Germany |
| Novartis Investigative Site | Münster | Germany |
| Novartis Investigative Site | Nuremberg | Germany |
| Novartis Investigative Site | Postdam | Germany |
| Novartis Investigative Site | Recklinghausen | Germany |
| Novartis Investigative Site | Regensburg | Germany |
| Novartis Investigative Site | Rosenheim | Germany |
| Novartis Investigative Site | Siegburg | Germany |
| Novartis Investigative Site | Stuttgart | Germany |
| Novartis Investigative Site | Ulm | Germany |
| Novartis Investigative Site | Würzburg | Germany |
| Active Laser Photocoagulation and Sham Injection |
Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment. Sham intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Laser Photocoagulation and Ranibizumab | Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment. Ranibizumab intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment. |
| BG001 | Active Laser Photocoagulation and Sham Injection | Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment. Sham intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment. |
| 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 in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12 | Mean change in Best-Corrected Visual Acuity (BCVA) letters at 12 months compared to baseline was measured using Visual acuity (VA). VA accounts for the number of letters a participant can see using Early Treatment Diabetic Retinopathy Study (EDTRS)-like visual acuity testing charts, from a sitting position at a testing distance of 4 meters. BCVA means that the participant's refraction is already taken into account when VA is determined. A higher BCVA number at 12 months in reference to baseline indicates improved BCVA. | Full Analysis Set consisted of all participants who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. No patient completed the 12 months observational period due to study early termination; therefore, the last observation carried forward (LOCF) method was used with data from 11.1 months. | Posted | Mean | Standard Deviation | Letters | 12 months |
|
|
|
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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 | Active Laser Photocoagulation and Ranibizumab | Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment. Ranibizumab intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment. | 14 | 85 | 32 | 85 | ||
| EG001 | Active Laser Photocoagulation and Sham Injection | Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment. Sham intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment. | 5 | 43 | 10 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | 14.0 | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | 14.0 | Systematic Assessment |
| |
| CORONARY ARTERY STENOSIS | Cardiac disorders | 14.0 | Systematic Assessment |
| |
| DIABETIC RETINAL OEDEMA (Study eye) | Eye disorders | 14.0 | Systematic Assessment |
| |
| DIABETIC RETINOPATHY (Fellow eye) | Eye disorders | 14.0 | Systematic Assessment |
| |
| RETINAL DETACHMENT (Fellow eye) | Eye disorders | 14.0 | Systematic Assessment |
| |
| VITREOUS HAEMORRHAGE (Fellow eye) | Eye disorders | 14.0 | Systematic Assessment |
| |
| ANAL SPHINCTER ATONY | Gastrointestinal disorders | 14.0 | Systematic Assessment |
| |
| CONCOMITANT DISEASE PROGRESSION | General disorders | 14.0 | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | 14.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | 14.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | 14.0 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | 14.0 | Systematic Assessment |
| |
| DIABETIC FOOT | Metabolism and nutrition disorders | 14.0 | Systematic Assessment |
| |
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | 14.0 | Systematic Assessment |
| |
| TYPE 1 DIABETES MELLITUS | Metabolism and nutrition disorders | 14.0 | Systematic Assessment |
| |
| CHONDROPATHY | Musculoskeletal and connective tissue disorders | 14.0 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | 14.0 | Systematic Assessment |
| |
| GASTROINTESTINAL TRACT ADENOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 14.0 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | 14.0 | Systematic Assessment |
| |
| LOSS OF CONSCIOUSNESS | Nervous system disorders | 14.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | 14.0 | Systematic Assessment |
| |
| HYPERTENSIVE CRISIS | Vascular disorders | 14.0 | Systematic Assessment |
| |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | 14.0 | Systematic Assessment |
| |
| THROMBOPHLEBITIS | Vascular disorders | 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| EYE IRRITATION (Study eye) | Eye disorders | 14.0 | Systematic Assessment |
| |
| EYE PAIN (Study eye) | Eye disorders | 14.0 | Systematic Assessment |
| |
| LACRIMATION INCREASED (Study eye) | Eye disorders | 14.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | 14.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | 14.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | 14.0 | Systematic Assessment |
|
Early study termination due to European drug approval.
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 |
|---|---|
| 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 |
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| Male |
|