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Study was prematurely discontinued as it was unethical to continue based on a change in ranibizumab (RFB) marketing authorization.
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The study was designed to assess the efficacy and safety of Lucentis® (ranibizumab 0.5 mg) in diabetic patients presenting with reduced visual acuity due to diabetic macular edema and evaluating spacing out of follow-up after initial intensive treatment phase.
This was a multicenteric, open-label, phase IIIb study, which comprised of 2 groups: the Main Group and the Rescue Group.
Patient's eligibility was assessed during a screening visit (Visit 1) which took place 14 days maximum before treatment initiation (Visit 2 [Day 0]). All patients were initially included in the Main Group and were to receive an initial loading treatment (6 injections during the intensive treatment phase i.e. every month from Day 0 to Month 5, followed by 2 additional injections at Months 8 and 11). Patients were to be followed-up every 3 months for 18 months (spaced-out follow-up period). Their visual acuity was to be checked at each study visit (Months 3, 6, 8, 11, 14, 17, 20, and 23) to assess their response to treatment. Patients who responded to treatment were maintained in the Main Group. Patients who did not meet pre defined criteria were moved to the Rescue Group and treated at the investigator's discretion.
The trial was terminated before any patient reached month 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab 0.5mg | Experimental | Intravitreal injection with standard dose of 0.5 mg/0.05mL Pro re nata (PRN) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab 0.5mg | Drug | Intravitreal injection with standard dose of 0.5 mg/0.05mL Pro re nata (PRN) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Stable BCVA in the Study Eye at 24 Months Compared With BCVA at 6 Months | Best-Corrected Visual Acuity (BCVA) letters were 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. Best value on the scale 100, worst 0. The number of participants with a stable BCVA (BCVA score at 6 months minus BCVA score at 24 months ≤4 letters) were reported. | Month 6 and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Stable BCVA in the Study Eye at 24 Months Compared With BCVA at 11 Months | Best-Corrected Visual Acuity (BCVA) letters were 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. Best value on the scale 100, worst 0. The number of participants with a stable BCVA (BCVA score at 11 months minus BCVA score at 24 months ≤4 letters) was calculated as well as its confidence interval at 95%. |
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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 | Bobigny | Seine Saint Denis | 93009 | France | ||
| Novartis Investigative Site |
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Participants were recruited from 10 centers across France.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranibizumab | Intravitreal injection with standard dose of 0.5 mg/0.05mL Pro re nata (PRN) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Month 11 and 24 |
| Visual Acuity: Number of Participants Keeping a BCVA Score Gain ≥10 Letters | 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. Best value on the scale 100, worst 0. The number of participants maintaining ≥10 letters gains in BCVA (compared to the baseline BCVA [Day 0]) value for each visit from Month 3 onwards were reported. | Baseline, Month 3, 6, 8 and 11 |
| Visual Acuity: Number of Participants Keeping a BCVA Score Gain ≥15 Letters | 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. Best value on the scale 100, worst 0. The number of participants maintaining ≥15 letters gains in BCVA (compared to the baseline BCVA [Day 0]) value for each visit from Month 3 onwards were reported. | Baseline, Months 3, 6, 8 and 11 |
| Visual Acuity: Number of Participants With a BCVA Loss ≥15 Letters at Months 8 and 11 Compared to Month 6 in the Study Eye. | Best-Corrected Visual Acuity (BCVA) letters were 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. Best value on the scale 100, worst 0. Number of participants presenting with a ≥15 letter loss in BCVA (compared to the value observed at 6 months) and leading to a treatment change (Rescue Group) for month 8 and 11 were analyzed. | Months 6, 8 and 11 |
| Visual Acuity : Change of BCVA From Baseline in the Study Eye (ETDRS) | 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. Best value on the scale 100, worst 0. The mean variation in BCVA was compared to the baseline BCVA value [Day 0] over a period of 24 months for patients in the Main Group. | Baseline, months 1, 2, 3, 4, 5, 6, 8 and 11 |
| Central Retinal Thickness : Change of Log OCT From Baseline in the Study Eye | Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative mean change from baseline indicates an improvement and a positive mean change from baseline indicates a worsening.The absolute variations of the Central Retinal Thickness (CRT) was measured using a Spectral Domain-Optical Coherence Tomography (SD-OCT) at each visit. Values were calculated as a log OCT (=log[CRT/200]). | Baseline, months 1, 2, 3, 4, 5, 6, 8 and 11 |
| Visual Acuity : Change of BCVA From Baseline in the Study Eye (ETDRS) - Rescue Group | 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. Best value on the scale 100, worst 0. The mean variation in BCVA was compared to the baseline BCVA value [Day 0] over a period of 24 months for patients in the Rescue Group. | Baseline, Months 3, 6, 8 and 11 |
| Central Retinal Thickness : Change of Log OCT From Baseline in the Study Eye - Rescue Group | Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative mean change from baseline indicates an improvement and a positive mean change from baseline indicates a worsening.The absolute variations of the Central Retinal Thickness (CRT) measured using a Spectral Domain-Optical Coherence Tomography (SD-OCT) at each visit. Values were calculated as a log OCT (=log[CRT/200]). | Baseline, Months 3, 6, 8 and 11 |
| Evaluation of the Spaced Out Follow-up on Visual Functions and Quality of Life | The global score obtained on the Visual Function Questionnaire 25 (VFQ 25) was compared from baseline to months 11 and 24 for the Main group and from baseline to months 12 and 24 for the Rescue group. | baseline, months 11, 12 and 24 |
| Bordeaux |
| 33000 |
| France |
| Novartis Investigative Site | Bordeaux | F-33076 | France |
| Novartis Investigative Site | Créteil | 94000 | France |
| Novartis Investigative Site | Le Kremlin-Bicêtre | 94275 | France |
| Novartis Investigative Site | Lyon | 69002 | France |
| Novartis Investigative Site | Nice | 06000 | France |
| Novartis Investigative Site | Paris | 75015 | France |
| Novartis Investigative Site | Paris | 75940 | France |
| Novartis Investigative Site | Poitiers | 86021 | France |
| Included Population - Main Group | Included population with evaluable patients at specific time points |
|
| Rescue Group | Participants who did not meet the pre-defined criteria were moved to Rescue Group |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranibizumab | Intravitreal injection with standard dose of 0.5 mg/0.05mL Pro re nata (PRN) |
| 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 | Number of Participants With a Stable BCVA in the Study Eye at 24 Months Compared With BCVA at 6 Months | Best-Corrected Visual Acuity (BCVA) letters were 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. Best value on the scale 100, worst 0. The number of participants with a stable BCVA (BCVA score at 6 months minus BCVA score at 24 months ≤4 letters) were reported. | Included population: No subjects included as analysis required data at month 24 and trial terminated before any subject reached month 12 | Posted | Month 6 and 24 |
|
| |||||||||||||||||||
| Secondary | Number of Participants With a Stable BCVA in the Study Eye at 24 Months Compared With BCVA at 11 Months | Best-Corrected Visual Acuity (BCVA) letters were 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. Best value on the scale 100, worst 0. The number of participants with a stable BCVA (BCVA score at 11 months minus BCVA score at 24 months ≤4 letters) was calculated as well as its confidence interval at 95%. | Included population: No subjects included as analysis required data at month 24 and trial terminated before any subject reached month 12 | Posted | Month 11 and 24 |
|
| |||||||||||||||||||
| Secondary | Visual Acuity: Number of Participants Keeping a BCVA Score Gain ≥10 Letters | 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. Best value on the scale 100, worst 0. The number of participants maintaining ≥10 letters gains in BCVA (compared to the baseline BCVA [Day 0]) value for each visit from Month 3 onwards were reported. | Included population with evaluable patients at specific time points. | Posted | Count of Participants | Participants | Baseline, Month 3, 6, 8 and 11 |
|
| |||||||||||||||||
| Secondary | Visual Acuity: Number of Participants Keeping a BCVA Score Gain ≥15 Letters | 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. Best value on the scale 100, worst 0. The number of participants maintaining ≥15 letters gains in BCVA (compared to the baseline BCVA [Day 0]) value for each visit from Month 3 onwards were reported. | Included population with evaluable patients at specific time points. | Posted | Count of Participants | Participants | Baseline, Months 3, 6, 8 and 11 |
|
| |||||||||||||||||
| Secondary | Visual Acuity: Number of Participants With a BCVA Loss ≥15 Letters at Months 8 and 11 Compared to Month 6 in the Study Eye. | Best-Corrected Visual Acuity (BCVA) letters were 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. Best value on the scale 100, worst 0. Number of participants presenting with a ≥15 letter loss in BCVA (compared to the value observed at 6 months) and leading to a treatment change (Rescue Group) for month 8 and 11 were analyzed. | Included population with evaluable patients at specific time points. | Posted | Count of Participants | Participants | Months 6, 8 and 11 |
|
| |||||||||||||||||
| Secondary | Visual Acuity : Change of BCVA From Baseline in the Study Eye (ETDRS) | 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. Best value on the scale 100, worst 0. The mean variation in BCVA was compared to the baseline BCVA value [Day 0] over a period of 24 months for patients in the Main Group. | Included population with evaluable patients at specific time points. | Posted | Mean | Standard Deviation | Letters | Baseline, months 1, 2, 3, 4, 5, 6, 8 and 11 |
|
| ||||||||||||||||
| Secondary | Central Retinal Thickness : Change of Log OCT From Baseline in the Study Eye | Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative mean change from baseline indicates an improvement and a positive mean change from baseline indicates a worsening.The absolute variations of the Central Retinal Thickness (CRT) was measured using a Spectral Domain-Optical Coherence Tomography (SD-OCT) at each visit. Values were calculated as a log OCT (=log[CRT/200]). | Included population: No subjects included as analysis required data at month 24 and trial terminated before any subject reached month 12 | Posted | Mean | Standard Deviation | log[μm/200] | Baseline, months 1, 2, 3, 4, 5, 6, 8 and 11 |
|
| ||||||||||||||||
| Secondary | Visual Acuity : Change of BCVA From Baseline in the Study Eye (ETDRS) - Rescue Group | 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. Best value on the scale 100, worst 0. The mean variation in BCVA was compared to the baseline BCVA value [Day 0] over a period of 24 months for patients in the Rescue Group. | Included population for subjects entering Rescue Group: No subjects provided evaluable data after switching to the Rescue Group | Posted | Baseline, Months 3, 6, 8 and 11 |
|
| |||||||||||||||||||
| Secondary | Central Retinal Thickness : Change of Log OCT From Baseline in the Study Eye - Rescue Group | Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative mean change from baseline indicates an improvement and a positive mean change from baseline indicates a worsening.The absolute variations of the Central Retinal Thickness (CRT) measured using a Spectral Domain-Optical Coherence Tomography (SD-OCT) at each visit. Values were calculated as a log OCT (=log[CRT/200]). | Included population for subjects entering Rescue Group: No subjects provided evaluable data after switching to the Rescue Group | Posted | Baseline, Months 3, 6, 8 and 11 |
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| Secondary | Evaluation of the Spaced Out Follow-up on Visual Functions and Quality of Life | The global score obtained on the Visual Function Questionnaire 25 (VFQ 25) was compared from baseline to months 11 and 24 for the Main group and from baseline to months 12 and 24 for the Rescue group. | Included population: No subjects included as analysis required data at month 24 and trial terminated before any subject reached month 12 | Posted | baseline, months 11, 12 and 24 |
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Adverse events (AEs) were collected from the patient screening onwards. However, a safety observation period which started from first injection until 4 weeks after discontinuation - up to 11 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 | Ranibizumab | Intravitreal injection with standard dose of 0.5 mg/0.05mL Pro re nata (PRN) | 0 | 31 | 2 | 31 | 12 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery stenosis | Cardiac disorders | MedDRA | Systematic Assessment |
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| Eye allergy (Both eyes) | Eye disorders | MedDRA | Systematic Assessment |
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| Halo vision (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
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| Macular oedema (Contralateral eye) | Eye disorders | MedDRA | Systematic Assessment |
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| Posterior capsule opacification (Contralateral eye) | Eye disorders | MedDRA | Systematic Assessment |
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| Vitreous haemorrhage (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Chills | General disorders | MedDRA | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA | Systematic Assessment |
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| Conjunctivitis (Both eyes) | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Conjunctivitis viral (Study eye) | Infections and infestations | MedDRA | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Microalbuminuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Peripheral arterial occlusive disease | 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 trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-1873 |
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D008268 | Macular Degeneration |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 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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