Trial Outcomes & Findings for Single Site, Masked, Randomized, Controlled Study to Assess Efficacy of Osurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Macular Edema Due to Central or Branch Retinal Vein Occlusion (NCT NCT01085734)
NCT ID: NCT01085734
Last Updated: 2014-04-21
Results Overview
Visual Acuity was measured with ETDRS visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
6 months
Results posted on
2014-04-21
Participant Flow
The study was conducted at a single center. The first subject for this study was screened on 18MAR2010 and enrolled on 26MAR2010. The subjects were existing patients in our medical clinic.
In total there were 10 screen failures; 4 did not meet the visual acuity requirements,3 did not meet the OCT requirements. One subject withdrew consent prior to randomization and one withdrew prior to randomization due to health issues
Participant milestones
| Measure |
Group 1
Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 micros
|
Group 2
Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
Group 1
Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 micros
|
Group 2
Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Single Site, Masked, Randomized, Controlled Study to Assess Efficacy of Osurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Macular Edema Due to Central or Branch Retinal Vein Occlusion
Baseline characteristics by cohort
| Measure |
Group 1
n=15 Participants
Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 micros
|
Group 2
n=15 Participants
Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 microns.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 13 • n=5 Participants
|
69 years
STANDARD_DEVIATION 19 • n=7 Participants
|
68 years
STANDARD_DEVIATION 16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsVisual Acuity was measured with ETDRS visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
Outcome measures
| Measure |
Group 1
n=14 Participants
Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
|
Group 2
n=11 Participants
Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
|
|---|---|---|
|
Change From Baseline Visual Acuity at 6 Months
|
2.3 ETDRS score
Standard Deviation 7.7
|
0.1 ETDRS score
Standard Deviation 13.3
|
SECONDARY outcome
Timeframe: baseline to 6 monthsnumber of Avastin and Ozurdex injections needed
Outcome measures
| Measure |
Group 1
n=14 Participants
Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
|
Group 2
n=11 Participants
Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
|
|---|---|---|
|
Number of Injections Needed
|
14 injections
|
11 injections
|
SECONDARY outcome
Timeframe: 6 monthsOCT central subfield thickness measured in microns
Outcome measures
| Measure |
Group 1
n=14 Participants
Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
|
Group 2
n=11 Participants
Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
|
|---|---|---|
|
Change in Macular Thickness and Macular Volume
|
45.4 microns
Standard Deviation 100.1
|
-55.6 microns
Standard Deviation 39.7
|
Adverse Events
Group 1
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Group 2
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=15 participants at risk
Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 micros
|
Group 2
n=15 participants at risk
Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 microns.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
breast cancer
|
6.7%
1/15 • Number of events 1 • 6 months
|
0.00%
0/15 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.00%
0/15 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
esophageal cancer
|
6.7%
1/15 • Number of events 1 • 6 months
|
0.00%
0/15 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
colon cancer
|
0.00%
0/15 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Immune system disorders
viral influenza
|
0.00%
0/15 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
osteoarthritis
|
6.7%
1/15 • Number of events 1 • 6 months
|
0.00%
0/15 • 6 months
|
|
Immune system disorders
organ transplant rejection
|
6.7%
1/15 • Number of events 1 • 6 months
|
0.00%
0/15 • 6 months
|
Other adverse events
| Measure |
Group 1
n=15 participants at risk
Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 micros
|
Group 2
n=15 participants at risk
Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 microns.
|
|---|---|---|
|
Eye disorders
worsening of cataract
|
6.7%
1/15 • Number of events 1 • 6 months
|
20.0%
3/15 • Number of events 3 • 6 months
|
|
Cardiac disorders
worsening of hypertension
|
6.7%
1/15 • Number of events 1 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
back pain
|
6.7%
1/15 • Number of events 1 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Ear and labyrinth disorders
Meniere's disease
|
6.7%
1/15 • Number of events 1 • 6 months
|
0.00%
0/15 • 6 months
|
|
Musculoskeletal and connective tissue disorders
osteoporosis
|
6.7%
1/15 • Number of events 1 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/15 • 6 months
|
13.3%
2/15 • Number of events 2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.00%
0/15 • 6 months
|
13.3%
2/15 • Number of events 2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis
|
0.00%
0/15 • 6 months
|
13.3%
2/15 • Number of events 2 • 6 months
|
|
General disorders
generalized weakness
|
0.00%
0/15 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Eye disorders
increased intraocular pressure
|
6.7%
1/15 • Number of events 1 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Eye disorders
worsening of epiretinal membrane
|
0.00%
0/15 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Eye disorders
subconjunctival hemorrhage
|
6.7%
1/15 • Number of events 1 • 6 months
|
0.00%
0/15 • 6 months
|
|
Renal and urinary disorders
urinary incontinence
|
0.00%
0/15 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
contusion left foot
|
0.00%
0/15 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Ear and labyrinth disorders
sinusitis
|
6.7%
1/15 • Number of events 1 • 6 months
|
0.00%
0/15 • 6 months
|
|
Ear and labyrinth disorders
inner ear infection
|
0.00%
0/15 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Eye disorders
vitreous floaters
|
0.00%
0/15 • 6 months
|
13.3%
2/15 • Number of events 2 • 6 months
|
|
Infections and infestations
infection left foot
|
0.00%
0/15 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Ear and labyrinth disorders
auditory disturbance
|
0.00%
0/15 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
puncture wounds to hands
|
0.00%
0/15 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Eye disorders
blurry vision
|
0.00%
0/15 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Infections and infestations
tooth infection
|
6.7%
1/15 • Number of events 1 • 6 months
|
0.00%
0/15 • 6 months
|
|
Eye disorders
discomfort right eye
|
6.7%
1/15 • Number of events 1 • 6 months
|
0.00%
0/15 • 6 months
|
|
Hepatobiliary disorders
nonfunctioning gallbladder
|
0.00%
0/15 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
anemia
|
6.7%
1/15 • Number of events 1 • 6 months
|
0.00%
0/15 • 6 months
|
|
Hepatobiliary disorders
cholescystitis
|
6.7%
1/15 • Number of events 1 • 6 months
|
0.00%
0/15 • 6 months
|
|
Musculoskeletal and connective tissue disorders
knee pain
|
0.00%
0/15 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
General disorders
headache
|
0.00%
0/15 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
6.7%
1/15 • Number of events 1 • 6 months
|
0.00%
0/15 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place