Trial Outcomes & Findings for Efficacy and Safety of Lucentis® (Ranibizumab Intravitreal Injections) in Chilean Patients With Diabetic Macular Edema. (NCT NCT02140411)
NCT ID: NCT02140411
Last Updated: 2019-02-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
21 participants
Primary outcome timeframe
baseline, week 48
Results posted on
2019-02-20
Participant Flow
Participant milestones
| Measure |
Ranibizumab
Ranibizumab 0.5 mg administered as an intravitreal injection
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Ranibizumab
Ranibizumab 0.5 mg administered as an intravitreal injection
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Efficacy and Safety of Lucentis® (Ranibizumab Intravitreal Injections) in Chilean Patients With Diabetic Macular Edema.
Baseline characteristics by cohort
| Measure |
Ranibizumab
n=21 Participants
Ranibizumab 0.5 mg administered as an intravitreal injection
|
|---|---|
|
Age, Continuous
|
64.43 Years
STANDARD_DEVIATION 8.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, week 48Population: Full Analysis Set (FAS) include all patients who received at least one dose of study medication, and have at least one post-baseline efficacy assessment. The FAS is analyzed according to the intention to treat ideal.
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.
Outcome measures
| Measure |
Ranibizumab
n=20 Participants
Ranibizumab 0.5 mg administered as an intravitreal injection
|
|---|---|
|
Mean Change From Baseline in Best Correct Visual Acuity (BCVA)
|
9.55 Letters
Standard Deviation 6.57
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 8, 12, 24 and 36Population: Full Analysis Set (FAS) include all patients who received at least one dose of study medication, and have at least one post-baseline efficacy assessment. The FAS is analyzed according to the intention to treat ideal
BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.
Outcome measures
| Measure |
Ranibizumab
n=20 Participants
Ranibizumab 0.5 mg administered as an intravitreal injection
|
|---|---|
|
Change From Baseline in Best-corrected Visual Acuity (BCVA) After Week 4, 8, 12, 24 and 36
Week 4
|
5.65 Letters
Standard Deviation 5.25
|
|
Change From Baseline in Best-corrected Visual Acuity (BCVA) After Week 4, 8, 12, 24 and 36
Week 8
|
6.90 Letters
Standard Deviation 4.27
|
|
Change From Baseline in Best-corrected Visual Acuity (BCVA) After Week 4, 8, 12, 24 and 36
Week 12
|
8.50 Letters
Standard Deviation 6.13
|
|
Change From Baseline in Best-corrected Visual Acuity (BCVA) After Week 4, 8, 12, 24 and 36
Week 24
|
8.05 Letters
Standard Deviation 7.32
|
|
Change From Baseline in Best-corrected Visual Acuity (BCVA) After Week 4, 8, 12, 24 and 36
Week 36
|
8.40 Letters
Standard Deviation 7.18
|
SECONDARY outcome
Timeframe: Baseline, week 48Population: Full Analysis Set (FAS) include all patients who received at least one dose of study medication, and have at least one post-baseline efficacy assessment. The FAS is analyzed according to the intention to treat ideal
Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation, an increase in thickness as compared to baseline may indicate a progression of the underlying disease.
Outcome measures
| Measure |
Ranibizumab
n=20 Participants
Ranibizumab 0.5 mg administered as an intravitreal injection
|
|---|---|
|
Change Over Time of the Intraretinal Thickness in Optical Coherence Tomography (OCT)
Left eye
|
367.06 Microns
Standard Deviation 91.44
|
|
Change Over Time of the Intraretinal Thickness in Optical Coherence Tomography (OCT)
Right eye
|
388.50 Microns
Standard Deviation 151.39
|
SECONDARY outcome
Timeframe: Week 48Population: Full Analysis Set (FAS) include all patients who received at least one dose of study medication, and have at least one post-baseline efficacy assessment. The FAS is analyzed according to the intention to treat ideal
Outcome measures
| Measure |
Ranibizumab
n=20 Participants
Ranibizumab 0.5 mg administered as an intravitreal injection
|
|---|---|
|
Number of Participants Receiving Injections of Ranibizumab 0.5 mg Over a 48 Week Treatment Period.
|
7 Count of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Full Analysis Set (FAS) include all patients who received at least one dose of study medication, and have at least one post-baseline efficacy assessment. The FAS is analyzed according to the intention to treat ideal
Number of participants with letters correctly identified were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.
Outcome measures
| Measure |
Ranibizumab
n=21 Participants
Ranibizumab 0.5 mg administered as an intravitreal injection
|
|---|---|
|
Number of Participants With Letters Gain / Loss at Week 52
5 or more letters gained
|
14 Count of Participants
|
|
Number of Participants With Letters Gain / Loss at Week 52
10 or more letters gained
|
8 Count of Participants
|
|
Number of Participants With Letters Gain / Loss at Week 52
15 or more letters gained
|
5 Count of Participants
|
|
Number of Participants With Letters Gain / Loss at Week 52
5 or more letters lost
|
0 Count of Participants
|
|
Number of Participants With Letters Gain / Loss at Week 52
10 or more letters lost
|
0 Count of Participants
|
|
Number of Participants With Letters Gain / Loss at Week 52
15 or more letters lost
|
0 Count of Participants
|
SECONDARY outcome
Timeframe: Baseline, week 48Population: Full Analysis Set (FAS) include all patients who received at least one dose of study medication, and have at least one post-baseline efficacy assessment. The FAS is analyzed according to the intention to treat ideal
"Visual functioning was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in visual functioning, while a negative change value indicates a worsening."
Outcome measures
| Measure |
Ranibizumab
n=20 Participants
Ranibizumab 0.5 mg administered as an intravitreal injection
|
|---|---|
|
Change in Mean Visual Function Questionnaire (VFQ-25)
Ocular pain
|
11.88 Score on a scale
Standard Deviation 23.81
|
|
Change in Mean Visual Function Questionnaire (VFQ-25)
Near activities
|
7.50 Score on a scale
Standard Deviation 16.64
|
|
Change in Mean Visual Function Questionnaire (VFQ-25)
Social Functioning
|
13.13 Score on a scale
Standard Deviation 15.95
|
|
Change in Mean Visual Function Questionnaire (VFQ-25)
Mental health
|
9.69 Score on a scale
Standard Deviation 31.90
|
|
Change in Mean Visual Function Questionnaire (VFQ-25)
Color vision
|
15 Score on a scale
Standard Deviation 27.39
|
|
Change in Mean Visual Function Questionnaire (VFQ-25)
Peripheral vision
|
7.50 Score on a scale
Standard Deviation 31.52
|
|
Change in Mean Visual Function Questionnaire (VFQ-25)
General health
|
12.50 Score on a scale
Standard Deviation 28.68
|
|
Change in Mean Visual Function Questionnaire (VFQ-25)
General vision
|
13 Score on a scale
Standard Deviation 14.90
|
|
Change in Mean Visual Function Questionnaire (VFQ-25)
Distance activities
|
9.62 Score on a scale
Standard Deviation 16.26
|
|
Change in Mean Visual Function Questionnaire (VFQ-25)
Role difficulties
|
10.63 Score on a scale
Standard Deviation 34.24
|
|
Change in Mean Visual Function Questionnaire (VFQ-25)
Dependency
|
13.75 Score on a scale
Standard Deviation 26.94
|
|
Change in Mean Visual Function Questionnaire (VFQ-25)
Driving
|
-0.0 Score on a scale
Standard Deviation 22.05
|
Adverse Events
Ranibizumab 0.5 mg
Serious events: 6 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ranibizumab 0.5 mg
n=21 participants at risk
Ranibizumab 0.5 mg administered as an intravitreal injection
|
|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Eye disorders
Vitreous haemorrhage
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Infections and infestations
Pharyngitis
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Infections and infestations
Pneumonia
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Infections and infestations
Pyelonephritis
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Nervous system disorders
Ischaemic stroke
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
Other adverse events
| Measure |
Ranibizumab 0.5 mg
n=21 participants at risk
Ranibizumab 0.5 mg administered as an intravitreal injection
|
|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
9.5%
2/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Eye disorders
Conjunctivitis allergic
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Eye disorders
Dry eye
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Eye disorders
Ocular hypertension
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Eye disorders
Visual impairment
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Gastrointestinal disorders
Gastritis
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
General disorders
Influenza like illness
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
General disorders
Nodule
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
General disorders
Oedema peripheral
|
19.0%
4/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
General disorders
Pyrexia
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Immune system disorders
Hypersensitivity
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Infections and infestations
Bronchitis
|
9.5%
2/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Infections and infestations
Conjunctivitis
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Infections and infestations
Gastroenteritis
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Infections and infestations
Gastroenteritis viral
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Infections and infestations
Influenza
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Infections and infestations
Pharyngitis
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Infections and infestations
Tonsillitis
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Infections and infestations
Urinary tract infection
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Infections and infestations
Viral pharyngitis
|
9.5%
2/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Injury, poisoning and procedural complications
Contusion
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Injury, poisoning and procedural complications
Joint injury
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Injury, poisoning and procedural complications
Laceration
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Injury, poisoning and procedural complications
Rib fracture
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Investigations
Intraocular pressure increased
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.5%
2/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Nervous system disorders
Migraine
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Psychiatric disorders
Anxiety disorder
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Social circumstances
Menopause
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
|
Surgical and medical procedures
Carpal tunnel decompression
|
4.8%
1/21 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months.
AE additional description
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-1873
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER