Trial Outcomes & Findings for Performance Assessment Tests in Working Individuals With DME Following Treatment With Ranibizumab (NCT NCT02107131)
NCT ID: NCT02107131
Last Updated: 2018-12-19
Results Overview
A change between two time points (Baseline and 12 months) is reported for Maximum Reading Speed.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
Month 12
Results posted on
2018-12-19
Participant Flow
Participant milestones
| Measure |
Monthly
Monthly Intravitreal ranibizumab 0.3mg
|
PRN Group
PRN Intravitreal ranibizumab 0.3mg
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
Reasons for withdrawal
| Measure |
Monthly
Monthly Intravitreal ranibizumab 0.3mg
|
PRN Group
PRN Intravitreal ranibizumab 0.3mg
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
mental instability
|
1
|
0
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Monthly
n=20 Participants
Monthly Intravitreal ranibizumab 0.3mg
|
PRN Group
n=20 Participants
PRN Intravitreal ranibizumab 0.3mg
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
24 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Month 12Population: MNREAD words per minute
A change between two time points (Baseline and 12 months) is reported for Maximum Reading Speed.
Outcome measures
| Measure |
Monthly
n=12 Participants
Monthly Intravitreal ranibizumab 0.3mg
|
PRN Group
n=11 Participants
PRN Intravitreal ranibizumab 0.3mg
|
|---|---|---|
|
A Change Between Two Time Points is Reported for Maximum Reading Speed
|
161.94 words per minute
Standard Deviation 43.56
|
167.65 words per minute
Standard Deviation 32.30
|
SECONDARY outcome
Timeframe: Month 12To evaluate the mean change in activity impairment from baseline to 12 months using and activity impairment questionnaire. Scale is from 0-10 with 0 being lowest (no effect on my daily activities) and 10 being highest (completely prevented me from doing my daily activities).
Outcome measures
| Measure |
Monthly
n=12 Participants
Monthly Intravitreal ranibizumab 0.3mg
|
PRN Group
n=9 Participants
PRN Intravitreal ranibizumab 0.3mg
|
|---|---|---|
|
Change in Activity Productivity
|
-2.25 Units on a scale
Standard Deviation 3.14
|
-0.78 Units on a scale
Standard Deviation 2.44
|
SECONDARY outcome
Timeframe: Month 12To determine the mean change in best-corrected visual acuity on ETDRS visual acuity chart at a starting distance of 4 meters from baseline. Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard. A higher letter score represents better functioning.
Outcome measures
| Measure |
Monthly
n=12 Participants
Monthly Intravitreal ranibizumab 0.3mg
|
PRN Group
n=12 Participants
PRN Intravitreal ranibizumab 0.3mg
|
|---|---|---|
|
Change in Visual Acuity
|
17.42 Letters
Standard Deviation 15.13
|
14.92 Letters
Standard Deviation 11.60
|
SECONDARY outcome
Timeframe: 12 monthsTo measure the mean change in contrast sensitivity scores on Pelli-Robson charts from baseline. Scale in assessing the log of the contract sensitivity score (CS score) is from 0-2.25, with 0 being no letters read on the contrast sensitivity chart, and 2.25 being all letters read on the contrast sensitivity chart. Total CS score = \[(total # letters correct - 3) x 0.05\].
Outcome measures
| Measure |
Monthly
n=11 Participants
Monthly Intravitreal ranibizumab 0.3mg
|
PRN Group
n=11 Participants
PRN Intravitreal ranibizumab 0.3mg
|
|---|---|---|
|
Change in Contrast Sensitivity
|
0.39 Units on a scale
Standard Deviation 0.45
|
0.26 Units on a scale
Standard Deviation 0.40
|
Adverse Events
Monthly
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
PRN Group
Serious events: 4 serious events
Other events: 8 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Monthly
n=20 participants at risk
Monthly Intravitreal ranibizumab 0.3mg
|
PRN Group
n=20 participants at risk
PRN Intravitreal ranibizumab 0.3mg
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
|
Injury, poisoning and procedural complications
fractured humerus and tibia
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
0.00%
0/20 • Through study completion, an average of 1 year.
|
|
Infections and infestations
Septic Knee
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
0.00%
0/20 • Through study completion, an average of 1 year.
|
|
Cardiac disorders
stress, cardiomyopathy, acute renal disfunction
|
0.00%
0/20 • Through study completion, an average of 1 year.
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.00%
0/20 • Through study completion, an average of 1 year.
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
|
Gastrointestinal disorders
lower back and abdominal pain
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
0.00%
0/20 • Through study completion, an average of 1 year.
|
|
Cardiac disorders
congestive heart failure
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
0.00%
0/20 • Through study completion, an average of 1 year.
|
|
Renal and urinary disorders
Urinary Tract Infection with Sepsis
|
0.00%
0/20 • Through study completion, an average of 1 year.
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
|
Eye disorders
Blurry Vision
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
0.00%
0/20 • Through study completion, an average of 1 year.
|
Other adverse events
| Measure |
Monthly
n=20 participants at risk
Monthly Intravitreal ranibizumab 0.3mg
|
PRN Group
n=20 participants at risk
PRN Intravitreal ranibizumab 0.3mg
|
|---|---|---|
|
Reproductive system and breast disorders
Upper respiratory infection
|
10.0%
2/20 • Through study completion, an average of 1 year.
|
20.0%
4/20 • Through study completion, an average of 1 year.
|
|
Infections and infestations
Flu/cold
|
40.0%
8/20 • Through study completion, an average of 1 year.
|
10.0%
2/20 • Through study completion, an average of 1 year.
|
|
Eye disorders
Eye Pain
|
15.0%
3/20 • Through study completion, an average of 1 year.
|
20.0%
4/20 • Through study completion, an average of 1 year.
|
|
Eye disorders
Eye redness
|
20.0%
4/20 • Through study completion, an average of 1 year.
|
25.0%
5/20 • Through study completion, an average of 1 year.
|
|
Eye disorders
Eye Itchiness (ocular pruitis)
|
15.0%
3/20 • Through study completion, an average of 1 year.
|
0.00%
0/20 • Through study completion, an average of 1 year.
|
|
Eye disorders
Blurry/distorted vision
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
10.0%
2/20 • Through study completion, an average of 1 year.
|
|
Immune system disorders
Allergies/ Congestion
|
10.0%
2/20 • Through study completion, an average of 1 year.
|
0.00%
0/20 • Through study completion, an average of 1 year.
|
|
Infections and infestations
Shingles
|
0.00%
0/20 • Through study completion, an average of 1 year.
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
|
Eye disorders
Floaters
|
15.0%
3/20 • Through study completion, an average of 1 year.
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
|
Eye disorders
Photophobia
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
|
Surgical and medical procedures
Selective Laser Trabeculotomy
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
0.00%
0/20 • Through study completion, an average of 1 year.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • Through study completion, an average of 1 year.
|
10.0%
2/20 • Through study completion, an average of 1 year.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • Through study completion, an average of 1 year.
|
0.00%
0/20 • Through study completion, an average of 1 year.
|
|
General disorders
Anxiety
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
0.00%
0/20 • Through study completion, an average of 1 year.
|
|
General disorders
Insomnia
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
0.00%
0/20 • Through study completion, an average of 1 year.
|
|
General disorders
fall
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
|
Gastrointestinal disorders
diarrhea
|
10.0%
2/20 • Through study completion, an average of 1 year.
|
0.00%
0/20 • Through study completion, an average of 1 year.
|
|
Injury, poisoning and procedural complications
leg injury
|
10.0%
2/20 • Through study completion, an average of 1 year.
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
|
Surgical and medical procedures
herniea/hernia repair
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
0.00%
0/20 • Through study completion, an average of 1 year.
|
|
Surgical and medical procedures
Cataract Extraction
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
0.00%
0/20 • Through study completion, an average of 1 year.
|
|
Eye disorders
Subconjunctival Hemorrhage
|
10.0%
2/20 • Through study completion, an average of 1 year.
|
0.00%
0/20 • Through study completion, an average of 1 year.
|
|
Gastrointestinal disorders
Gastroenteritis
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
0.00%
0/20 • Through study completion, an average of 1 year.
|
|
Infections and infestations
Heart Infection
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
|
Gastrointestinal disorders
Food Poisoning
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
0.00%
0/20 • Through study completion, an average of 1 year.
|
|
General disorders
Hospitalization for swelling and fluid
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
0.00%
0/20 • Through study completion, an average of 1 year.
|
|
Renal and urinary disorders
Kidney stone
|
0.00%
0/20 • Through study completion, an average of 1 year.
|
5.0%
1/20 • Through study completion, an average of 1 year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place