Trial Outcomes & Findings for Safety and Efficacy of Ranibizumab in Diabetic Macular Edema (NCT NCT01131585)
NCT ID: NCT01131585
Last Updated: 2012-08-30
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
128 participants
Primary outcome timeframe
12 months
Results posted on
2012-08-30
Participant Flow
Participants did not complete study due to early termination. Study was terminated because of drug approval.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
85
|
43
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
85
|
43
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Abnormal laboratory value
|
1
|
0
|
|
Overall Study
Unsatisfactory therapeutic effect
|
0
|
3
|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Administrative problems
|
1
|
1
|
|
Overall Study
Study termination
|
78
|
32
|
Baseline Characteristics
Safety and Efficacy of Ranibizumab in Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
Active Laser Photocoagulation and Ranibizumab
n=85 Participants
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.
|
Active Laser Photocoagulation and Sham Injection
n=43 Participants
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.
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
>=18 years
|
63.5 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
63.5 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
63.5 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Active Laser Photocoagulation and Ranibizumab
n=85 Participants
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.
|
Active Laser Photocoagulation and Sham Injection
n=43 Participants
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.
|
|---|---|---|
|
Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12
|
6.5 Letters
Standard Deviation 8.6
|
1.4 Letters
Standard Deviation 7.3
|
Adverse Events
Active Laser Photocoagulation and Ranibizumab
Serious events: 14 serious events
Other events: 32 other events
Deaths: 0 deaths
Active Laser Photocoagulation and Sham Injection
Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Laser Photocoagulation and Ranibizumab
n=85 participants at risk
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.
|
Active Laser Photocoagulation and Sham Injection
n=43 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
1.2%
1/85
|
0.00%
0/43
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/85
|
2.3%
1/43
|
|
Cardiac disorders
CORONARY ARTERY STENOSIS
|
0.00%
0/85
|
2.3%
1/43
|
|
Eye disorders
DIABETIC RETINAL OEDEMA (Study eye)
|
1.2%
1/85
|
0.00%
0/43
|
|
Eye disorders
DIABETIC RETINOPATHY (Fellow eye)
|
1.2%
1/85
|
0.00%
0/43
|
|
Eye disorders
RETINAL DETACHMENT (Fellow eye)
|
0.00%
0/85
|
4.7%
2/43
|
|
Eye disorders
VITREOUS HAEMORRHAGE (Fellow eye)
|
0.00%
0/85
|
2.3%
1/43
|
|
Gastrointestinal disorders
ANAL SPHINCTER ATONY
|
1.2%
1/85
|
0.00%
0/43
|
|
General disorders
CONCOMITANT DISEASE PROGRESSION
|
0.00%
0/85
|
2.3%
1/43
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
1.2%
1/85
|
0.00%
0/43
|
|
Infections and infestations
CELLULITIS
|
1.2%
1/85
|
0.00%
0/43
|
|
Infections and infestations
PNEUMONIA
|
1.2%
1/85
|
0.00%
0/43
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
1.2%
1/85
|
0.00%
0/43
|
|
Metabolism and nutrition disorders
DIABETIC FOOT
|
1.2%
1/85
|
0.00%
0/43
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
2.4%
2/85
|
0.00%
0/43
|
|
Metabolism and nutrition disorders
TYPE 1 DIABETES MELLITUS
|
0.00%
0/85
|
2.3%
1/43
|
|
Musculoskeletal and connective tissue disorders
CHONDROPATHY
|
0.00%
0/85
|
2.3%
1/43
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/85
|
2.3%
1/43
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTROINTESTINAL TRACT ADENOMA
|
1.2%
1/85
|
0.00%
0/43
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
1.2%
1/85
|
0.00%
0/43
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
1.2%
1/85
|
0.00%
0/43
|
|
Vascular disorders
HYPERTENSION
|
1.2%
1/85
|
0.00%
0/43
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
1.2%
1/85
|
0.00%
0/43
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
1.2%
1/85
|
0.00%
0/43
|
|
Vascular disorders
THROMBOPHLEBITIS
|
1.2%
1/85
|
0.00%
0/43
|
Other adverse events
| Measure |
Active Laser Photocoagulation and Ranibizumab
n=85 participants at risk
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.
|
Active Laser Photocoagulation and Sham Injection
n=43 participants at risk
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.
|
|---|---|---|
|
Eye disorders
EYE IRRITATION (Study eye)
|
5.9%
5/85 • Number of events 5
|
0.00%
0/43
|
|
Eye disorders
EYE PAIN (Study eye)
|
15.3%
13/85 • Number of events 13
|
9.3%
4/43 • Number of events 4
|
|
Eye disorders
LACRIMATION INCREASED (Study eye)
|
5.9%
5/85 • Number of events 5
|
2.3%
1/43 • Number of events 1
|
|
Infections and infestations
NASOPHARYNGITIS
|
15.3%
13/85 • Number of events 13
|
14.0%
6/43 • Number of events 6
|
|
Nervous system disorders
HEADACHE
|
5.9%
5/85 • Number of events 5
|
2.3%
1/43 • Number of events 1
|
|
Vascular disorders
HYPERTENSION
|
4.7%
4/85 • Number of events 4
|
9.3%
4/43 • Number of events 4
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 41 61 324 1111
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