Trial Outcomes & Findings for Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema (NCT NCT00989989)
NCT ID: NCT00989989
Last Updated: 2012-10-18
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 average change from baseline of BCVA indicates improvement.
COMPLETED
PHASE3
396 participants
12 months
2012-10-18
Participant Flow
Participant milestones
| Measure |
Adjunctive Treatment
Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
|
Monotherapy Treatment
Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
|
Laser Control
Active laser treatment plus sham intravitreal injections.
|
|---|---|---|---|
|
Overall Study
STARTED
|
132
|
133
|
131
|
|
Overall Study
COMPLETED
|
114
|
123
|
108
|
|
Overall Study
NOT COMPLETED
|
18
|
10
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
Adjunctive Treatment
n=132 Participants
Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
|
Monotherapy Treatment
n=133 Participants
Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
|
Laser Control
n=131 Participants
Active laser treatment plus sham intravitreal injections.
|
Total
n=396 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
61.2 years
STANDARD_DEVIATION 10.52 • n=93 Participants
|
60.7 years
STANDARD_DEVIATION 9.37 • n=4 Participants
|
61.5 years
STANDARD_DEVIATION 9.68 • n=27 Participants
|
61.1 years
STANDARD_DEVIATION 9.85 • n=483 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
56 Participants
n=27 Participants
|
173 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=93 Participants
|
81 Participants
n=4 Participants
|
75 Participants
n=27 Participants
|
223 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The Full Analysis Set (FAS) consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had at least one post-baseline assessment for Best-Corrected Visual Acuity.
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 average change from baseline of BCVA indicates improvement.
Outcome measures
| Measure |
Adjunctive Treatment
n=129 Participants
Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
|
Monotherapy Treatment
n=133 Participants
Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
|
Laser Control
n=128 Participants
Active laser treatment plus sham intravitreal injections.
|
|---|---|---|---|
|
Average Change From Baseline of Best-Corrected Visual Acuity (BCVA) Over 12 Months (From Month 1 to Month 12 Compared to Baseline)
|
5.7 Letters
Standard Deviation 7.20
|
5.9 Letters
Standard Deviation 6.02
|
1.4 Letters
Standard Deviation 6.49
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had Central Retinal Subfield Thickness value with signal strength ≥ 5 for Carl Zeiss Optical Coherence Tomography 3 system.
Central Retinal Subfield Thickness (CRST) was measured using Optical Coherence Tomography (OCT) in micrometers. A negative change from baseline of CRST indicates improvement.
Outcome measures
| Measure |
Adjunctive Treatment
n=115 Participants
Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
|
Monotherapy Treatment
n=116 Participants
Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
|
Laser Control
n=115 Participants
Active laser treatment plus sham intravitreal injections.
|
|---|---|---|---|
|
Change From Baseline on Central Retinal Subfield Thickness (CRST) at Month 12
|
-171.8 micrometers
Standard Deviation 160.85
|
-134.6 micrometers
Standard Deviation 131.17
|
-57.2 micrometers
Standard Deviation 118.60
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had intra-retinal cysts in any of the 6 sections of the study eye at baseline - not applicable means there was no intra-retinal cyst at baseline.
Presence or absence of intra-retinal cysts in any of the 6 sections of the study eye was measured using Optical Coherence Tomography (OCT). A complete resolution or decrease from baseline of intra-retinal cysts indicates improvement.
Outcome measures
| Measure |
Adjunctive Treatment
n=78 Participants
Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
|
Monotherapy Treatment
n=77 Participants
Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
|
Laser Control
n=77 Participants
Active laser treatment plus sham intravitreal injections.
|
|---|---|---|---|
|
Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline
missing
|
31.2 percentage of participants
|
28.2 percentage of participants
|
32.5 percentage of participants
|
|
Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline
complete resolution
|
19.5 percentage of participants
|
21.8 percentage of participants
|
6.5 percentage of participants
|
|
Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline
decrease
|
40.3 percentage of participants
|
42.3 percentage of participants
|
35.1 percentage of participants
|
|
Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline
no change
|
5.2 percentage of participants
|
5.1 percentage of participants
|
15.6 percentage of participants
|
|
Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline
increase
|
1.3 percentage of participants
|
1.3 percentage of participants
|
10.4 percentage of participants
|
|
Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline
not applicable
|
2.6 percentage of participants
|
1.3 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had sub-retinal fluid in any of the 6 sections of the study eye at baseline. Not applicable means there was no sub-retinal fluid at baseline.
Presence or absence of sub-retinal fluid in any of the 6 sections of the study eye was measured using Optical Coherence Tomography (OCT). A complete resolution or decrease from baseline of sub-retinal fluid indicates improvement.
Outcome measures
| Measure |
Adjunctive Treatment
n=22 Participants
Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
|
Monotherapy Treatment
n=27 Participants
Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
|
Laser Control
n=16 Participants
Active laser treatment plus sham intravitreal injections.
|
|---|---|---|---|
|
Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline
complete resolution
|
13.6 percentage of participants
|
33.3 percentage of participants
|
25.0 percentage of participants
|
|
Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline
decrease
|
18.2 percentage of participants
|
11.1 percentage of participants
|
18.8 percentage of participants
|
|
Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline
no change
|
4.5 percentage of participants
|
0 percentage of participants
|
6.3 percentage of participants
|
|
Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline
increase
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline
not applicable
|
31.8 percentage of participants
|
18.5 percentage of participants
|
12.5 percentage of participants
|
|
Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline
missing
|
31.8 percentage of participants
|
37.0 percentage of participants
|
37.5 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.
Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at month 12 indicates a positive outcome.
Outcome measures
| Measure |
Adjunctive Treatment
n=122 Participants
Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
|
Monotherapy Treatment
n=121 Participants
Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
|
Laser Control
n=118 Participants
Active laser treatment plus sham intravitreal injections.
|
|---|---|---|---|
|
Percent of Participants With Visual Acuity Above 73 Letters at Month 12
|
20.5 percentage of participants
|
16.5 percentage of participants
|
8.5 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.
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 gain of 10 or more BCVA letters from baseline indicates improvement. A BCVA of 84 letters or more at Month 12 indicates improvement.
Outcome measures
| Measure |
Adjunctive Treatment
n=129 Participants
Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
|
Monotherapy Treatment
n=133 Participants
Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
|
Laser Control
n=128 Participants
Active laser treatment plus sham intravitreal injections.
|
|---|---|---|---|
|
Percent of Participants Who Gained >= 10 Letters at Month 12 Compared to Baseline
|
37.2 Percentage of participants
37.2
|
33.8 Percentage of participants
33.8
|
13.3 Percentage of participants
13.3
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.
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 loss of 10 or more BCVA letters from baseline indicates worsening.
Outcome measures
| Measure |
Adjunctive Treatment
n=129 Participants
Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
|
Monotherapy Treatment
n=133 Participants
Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
|
Laser Control
n=128 Participants
Active laser treatment plus sham intravitreal injections.
|
|---|---|---|---|
|
Percent of Participants Who Lost >= 10 Letters at Month 12 Compared to Baseline
|
5.4 Percentage of participants
|
3.0 Percentage of participants
|
6.3 Percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.
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 gain of 15 or more BCVA letters from baseline indicates improvement. A BCVA of 84 letters or more at Month 12 indicates improvement.
Outcome measures
| Measure |
Adjunctive Treatment
n=129 Participants
Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
|
Monotherapy Treatment
n=133 Participants
Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
|
Laser Control
n=128 Participants
Active laser treatment plus sham intravitreal injections.
|
|---|---|---|---|
|
Percent of Participants Who Gained >= 15 Letters at Month 12 Compared to Baseline
|
17.8 Percentage of participants
|
18.8 Percentage of participants
|
7.8 Percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.
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 loss of 15 or more BCVA letters from baseline indicates worsening.
Outcome measures
| Measure |
Adjunctive Treatment
n=129 Participants
Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
|
Monotherapy Treatment
n=133 Participants
Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
|
Laser Control
n=128 Participants
Active laser treatment plus sham intravitreal injections.
|
|---|---|---|---|
|
Percent of Participants Who Lost >= 15 Letters at Month 12 Compared to Baseline
|
3.9 Percentage of participants
|
1.5 Percentage of participants
|
3.9 Percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.
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 |
Adjunctive Treatment
n=129 Participants
Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
|
Monotherapy Treatment
n=133 Participants
Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
|
Laser Control
n=128 Participants
Active laser treatment plus sham intravitreal injections.
|
|---|---|---|---|
|
Best-Corrected Visual Acuity (BCVA) Mean Change From Baseline at Month 12
|
6.4 Letters
Standard Deviation 10.67
|
6.6 Letters
Standard Deviation 7.68
|
1.8 Letters
Standard Deviation 8.27
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had at least one post-baseline assessment for Best-Corrected Visual Acuity.
The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Participants self-rate their health on a visual, vertical analogue scale from 0 to 100 where the endpoints are labeled "Best imaginable health state" (100) and "worst imaginable health state" (0).
Outcome measures
| Measure |
Adjunctive Treatment
n=127 Participants
Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
|
Monotherapy Treatment
n=129 Participants
Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
|
Laser Control
n=125 Participants
Active laser treatment plus sham intravitreal injections.
|
|---|---|---|---|
|
Patient Outcome Measure Euro Quality of Life Questionnaire (EQ-5D)
|
2.8 units on a scale
Standard Deviation 14.38
|
-1.1 units on a scale
Standard Deviation 12.74
|
1.0 units on a scale
Standard Deviation 13.90
|
Adverse Events
Monotherapy Treatment
Adjunctive Treatment
Laser Control
Serious adverse events
| Measure |
Monotherapy Treatment
n=133 participants at risk
Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
|
Adjunctive Treatment
n=132 participants at risk
Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
|
Laser Control
n=128 participants at risk
Active laser treatment plus sham intravitreal injections.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.00%
0/133
|
0.76%
1/132
|
0.00%
0/128
|
|
Cardiac disorders
Acute myocardial infarction
|
0.75%
1/133
|
0.00%
0/132
|
0.00%
0/128
|
|
Cardiac disorders
Angina pectoris
|
1.5%
2/133
|
0.00%
0/132
|
0.78%
1/128
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/133
|
0.76%
1/132
|
0.00%
0/128
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/133
|
1.5%
2/132
|
0.00%
0/128
|
|
Cardiac disorders
Myocardial infarction
|
0.75%
1/133
|
0.00%
0/132
|
0.00%
0/128
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/133
|
0.76%
1/132
|
0.00%
0/128
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.75%
1/133
|
0.00%
0/132
|
0.00%
0/128
|
|
Eye disorders
Cataract (Fellow eye)
|
0.75%
1/133
|
1.5%
2/132
|
0.00%
0/128
|
|
Eye disorders
Cataract (Study eye)
|
0.00%
0/133
|
1.5%
2/132
|
0.00%
0/128
|
|
Eye disorders
Diabetic retinal oedema (Fellow eye)
|
0.75%
1/133
|
0.00%
0/132
|
0.00%
0/128
|
|
Eye disorders
Diabetic retinopathy (Fellow eye)
|
0.75%
1/133
|
0.76%
1/132
|
0.00%
0/128
|
|
Eye disorders
Maculopathy (Fellow eye)
|
1.5%
2/133
|
0.00%
0/132
|
0.00%
0/128
|
|
Eye disorders
Retinal detachment (Fellow eye)
|
0.00%
0/133
|
0.76%
1/132
|
0.00%
0/128
|
|
Eye disorders
Retinal detachment (Study eye)
|
0.00%
0/133
|
0.76%
1/132
|
0.00%
0/128
|
|
Eye disorders
Retinal haemorrhage (Fellow eye)
|
0.75%
1/133
|
0.00%
0/132
|
0.00%
0/128
|
|
Eye disorders
Vitreous haemorrhage (Fellow eye)
|
1.5%
2/133
|
0.00%
0/132
|
0.78%
1/128
|
|
Eye disorders
Vitreous haemorrhage (Study eye)
|
0.00%
0/133
|
0.00%
0/132
|
0.78%
1/128
|
|
Gastrointestinal disorders
Epulis
|
0.00%
0/133
|
0.00%
0/132
|
0.78%
1/128
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/133
|
0.00%
0/132
|
0.78%
1/128
|
|
Gastrointestinal disorders
Polyp colorectal
|
0.75%
1/133
|
0.00%
0/132
|
0.00%
0/128
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/133
|
0.76%
1/132
|
0.00%
0/128
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/133
|
0.76%
1/132
|
0.00%
0/128
|
|
Infections and infestations
Cellulitis
|
0.00%
0/133
|
0.76%
1/132
|
0.78%
1/128
|
|
Infections and infestations
Conjunctivitis bacterial (Study eye)
|
0.00%
0/133
|
0.76%
1/132
|
0.00%
0/128
|
|
Infections and infestations
Diabetic gangrene
|
0.00%
0/133
|
0.00%
0/132
|
0.78%
1/128
|
|
Infections and infestations
Endophthalmitis (Study eye)
|
0.75%
1/133
|
1.5%
2/132
|
0.00%
0/128
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/133
|
0.76%
1/132
|
0.00%
0/128
|
|
Infections and infestations
Pneumonia
|
0.00%
0/133
|
0.76%
1/132
|
0.78%
1/128
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/133
|
0.76%
1/132
|
0.00%
0/128
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/133
|
0.76%
1/132
|
0.00%
0/128
|
|
Infections and infestations
Tuberculous pleurisy
|
0.75%
1/133
|
0.00%
0/132
|
0.00%
0/128
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/133
|
0.00%
0/132
|
0.78%
1/128
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/133
|
0.76%
1/132
|
0.00%
0/128
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/133
|
0.76%
1/132
|
0.00%
0/128
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/133
|
0.00%
0/132
|
0.78%
1/128
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.75%
1/133
|
0.00%
0/132
|
0.00%
0/128
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/133
|
0.76%
1/132
|
0.00%
0/128
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.75%
1/133
|
0.00%
0/132
|
0.00%
0/128
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/133
|
0.00%
0/132
|
0.78%
1/128
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
1.5%
2/133
|
0.00%
0/132
|
0.00%
0/128
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/133
|
0.00%
0/132
|
0.78%
1/128
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/133
|
0.00%
0/132
|
0.78%
1/128
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/133
|
0.00%
0/132
|
0.78%
1/128
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/133
|
0.00%
0/132
|
0.78%
1/128
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/133
|
0.00%
0/132
|
1.6%
2/128
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.75%
1/133
|
0.00%
0/132
|
0.00%
0/128
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.75%
1/133
|
0.00%
0/132
|
0.00%
0/128
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/133
|
0.00%
0/132
|
0.78%
1/128
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.00%
0/133
|
0.76%
1/132
|
0.00%
0/128
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.75%
1/133
|
0.00%
0/132
|
0.00%
0/128
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/133
|
0.00%
0/132
|
1.6%
2/128
|
|
Nervous system disorders
Diabetic neuropathy (Study eye)
|
0.00%
0/133
|
0.76%
1/132
|
0.00%
0/128
|
|
Nervous system disorders
Lacunar infarction
|
0.75%
1/133
|
0.00%
0/132
|
0.00%
0/128
|
|
Nervous system disorders
Spondylitic myelopathy
|
0.00%
0/133
|
0.00%
0/132
|
0.78%
1/128
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/133
|
0.76%
1/132
|
0.00%
0/128
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/133
|
0.00%
0/132
|
0.78%
1/128
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/133
|
0.76%
1/132
|
0.00%
0/128
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/133
|
0.76%
1/132
|
0.00%
0/128
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/133
|
0.76%
1/132
|
0.00%
0/128
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/133
|
0.00%
0/132
|
0.78%
1/128
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/133
|
0.76%
1/132
|
0.00%
0/128
|
Other adverse events
| Measure |
Monotherapy Treatment
n=133 participants at risk
Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
|
Adjunctive Treatment
n=132 participants at risk
Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
|
Laser Control
n=128 participants at risk
Active laser treatment plus sham intravitreal injections.
|
|---|---|---|---|
|
Eye disorders
Conjunctival haemorrhage (Study eye)
|
12.8%
17/133
|
9.1%
12/132
|
5.5%
7/128
|
|
Eye disorders
Diabetic retinal oedema (Fellow eye)
|
8.3%
11/133
|
6.1%
8/132
|
1.6%
2/128
|
|
Infections and infestations
Nasopharyngitis
|
7.5%
10/133
|
7.6%
10/132
|
6.2%
8/128
|
|
Vascular disorders
Hypertension
|
4.5%
6/133
|
5.3%
7/132
|
4.7%
6/128
|
Additional Information
Study Director
Novartis Pharmaceuticals
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