Trial Outcomes & Findings for Ozurdex as Adjunct to Avastin Compared to Avastin Alone in Treatment of Patients With Diabetic Macular Edema (NCT NCT01309451)
NCT ID: NCT01309451
Last Updated: 2014-10-29
Results Overview
Visual Acuity was measured with the Early Treatment of Diabetic Retinopathy Study (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
40 participants
Primary outcome timeframe
baseline to 12 month
Results posted on
2014-10-29
Participant Flow
The study was conducted at a single center. The sample size was 40 eyes (30 subjects, 10 subjects had both eyes in study)
Subjects were randomly assigned to either bevacizumab alone or bevacizumab plus Ozurdex in a 1:1 ratio. When both eyes were eligible, the right eye was randomized and the left eye was assigned to the other group. We had a total of 30 subjects, 10 with both eyes. 19 eyes were in the Bevacizumab Alone group and 21 eyes were in the Combined Group.
Participant milestones
| Measure |
Bevacizumab Alone
monthly injection of bevacizumab intravitreally when retreatment criteria met
|
Combined Group
bevacizumab plus Ozurdex group received bevacizumab at baseline followed by Ozurdex at the one month visit. Retreatment with bevaciumab given at monthly intervals when retreatment criteria met except for months 5 and 10 when retreatment with Ozurdex was given.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
21
|
|
Overall Study
COMPLETED
|
17
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ozurdex as Adjunct to Avastin Compared to Avastin Alone in Treatment of Patients With Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
Bevacizumab Alone
n=19 Participants
Bevacizumab only
|
Combine Group
n=21 Participants
Bevacizumab plus Ozurdex
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 9 • n=99 Participants
|
59 years
STANDARD_DEVIATION 12 • n=107 Participants
|
60.5 years
STANDARD_DEVIATION 10 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
19 eyes
n=99 Participants
|
21 eyes
n=107 Participants
|
40 eyes
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline to 12 monthPopulation: The unit of measure is EYES rather than actual number of participants
Visual Acuity was measured with the Early Treatment of Diabetic Retinopathy Study (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 |
Bevacizumab Alone
n=19 Participants
Bevacizumab: intravitreal, 1.25mg., monthly
|
Combined Group
n=21 Participants
Bevacizumab plus Ozurdex
Bevacizumab: intravitreal, 1.25mg., monthly
dexamethasone intravitreal implant: 0.7mg, intravitreal every 4 months
|
|---|---|---|
|
Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline
|
4.9 letters
Standard Deviation 12.3
|
5.4 letters
Standard Deviation 10.7
|
PRIMARY outcome
Timeframe: change in OCT CST from baseline to twelve monthschange in optical coherence tomography central subfield thickness
Outcome measures
| Measure |
Bevacizumab Alone
n=19 Participants
Bevacizumab: intravitreal, 1.25mg., monthly
|
Combined Group
n=21 Participants
Bevacizumab plus Ozurdex
Bevacizumab: intravitreal, 1.25mg., monthly
dexamethasone intravitreal implant: 0.7mg, intravitreal every 4 months
|
|---|---|---|
|
OCT CST
|
30 microns
Standard Deviation 100
|
45 microns
Standard Deviation 107
|
Adverse Events
Bevacizumab Alone Group
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Combined Group
Serious events: 8 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab Alone Group
n=9 participants at risk
bevacizumab 1.25mg intravitreally
|
Combined Group
n=21 participants at risk
bevacizumab 1.25mg intravitreally plus Ozurdex THIS GROUP ALSO INCLUDES PARTICIPANTS WHO HAD BOTH EYES IN THE STUDY (they received bevacizumab alone in one eye and bavacizumab + Ozurdex in the other.
|
|---|---|---|
|
Renal and urinary disorders
acute renal insufficiency
|
11.1%
1/9 • Number of events 1 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Infections and infestations
cellulitis
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Vascular disorders
cerebrovascular accident
|
11.1%
1/9 • Number of events 1 • 1 year
|
0.00%
0/21 • 1 year
|
|
Cardiac disorders
coronary artery disease
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
hyperkalemia
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
pancytopenia
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
spinal stenosis
|
11.1%
1/9 • Number of events 1 • 1 year
|
0.00%
0/21 • 1 year
|
|
General disorders
generalized weakness
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Cardiac disorders
worsening of hypertension
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Bevacizumab Alone Group
n=9 participants at risk
bevacizumab 1.25mg intravitreally
|
Combined Group
n=21 participants at risk
bevacizumab 1.25mg intravitreally plus Ozurdex THIS GROUP ALSO INCLUDES PARTICIPANTS WHO HAD BOTH EYES IN THE STUDY (they received bevacizumab alone in one eye and bavacizumab + Ozurdex in the other.
|
|---|---|---|
|
Nervous system disorders
headaches
|
11.1%
1/9 • Number of events 1 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
renal insufficiency
|
11.1%
1/9 • Number of events 1 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
anemia
|
0.00%
0/9 • 1 year
|
9.5%
2/21 • Number of events 2 • 1 year
|
|
Cardiac disorders
angina
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Psychiatric disorders
anxiety
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
blepharitis
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
osteophyte right foot
|
11.1%
1/9 • Number of events 1 • 1 year
|
0.00%
0/21 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis
|
0.00%
0/9 • 1 year
|
9.5%
2/21 • Number of events 2 • 1 year
|
|
Infections and infestations
canaliculitis
|
11.1%
1/9 • Number of events 1 • 1 year
|
0.00%
0/21 • 1 year
|
|
Musculoskeletal and connective tissue disorders
carpal tunnel syndrome
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Infections and infestations
cellulitis
|
0.00%
0/9 • 1 year
|
9.5%
2/21 • Number of events 2 • 1 year
|
|
Cardiac disorders
congestive heart failure
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
contusion left arm
|
11.1%
1/9 • Number of events 1 • 1 year
|
0.00%
0/21 • 1 year
|
|
Eye disorders
corneal abrasion
|
11.1%
1/9 • Number of events 1 • 1 year
|
0.00%
0/21 • 1 year
|
|
Eye disorders
corneal precipatates
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Cardiac disorders
coronary artery disease
|
0.00%
0/9 • 1 year
|
9.5%
2/21 • Number of events 2 • 1 year
|
|
General disorders
cough
|
0.00%
0/9 • 1 year
|
9.5%
2/21 • Number of events 2 • 1 year
|
|
Eye disorders
cyst lower eyelid
|
11.1%
1/9 • Number of events 1 • 1 year
|
0.00%
0/21 • 1 year
|
|
Psychiatric disorders
decreased ability to concentrate
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Eye disorders
decreased visual acuity
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
degenerative joint disease
|
11.1%
1/9 • Number of events 1 • 1 year
|
0.00%
0/21 • 1 year
|
|
Eye disorders
ocular discomfort
|
11.1%
1/9 • Number of events 1 • 1 year
|
0.00%
0/21 • 1 year
|
|
General disorders
dizziness
|
22.2%
2/9 • Number of events 2 • 1 year
|
0.00%
0/21 • 1 year
|
|
Eye disorders
dry eye syndrome
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Ear and labyrinth disorders
otitis media
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Eye disorders
epiretinal membrane
|
55.6%
5/9 • Number of events 5 • 1 year
|
19.0%
4/21 • Number of events 4 • 1 year
|
|
Infections and infestations
esophageal candidiasis
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
fallen arch left foot
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Eye disorders
vitreous floater
|
11.1%
1/9 • Number of events 1 • 1 year
|
19.0%
4/21 • Number of events 4 • 1 year
|
|
Renal and urinary disorders
peripheral edema
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
fracture ribs
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
adhesive capsulitis
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Eye disorders
suspected glaucoma
|
11.1%
1/9 • Number of events 1 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
heartburn
|
11.1%
1/9 • Number of events 1 • 1 year
|
0.00%
0/21 • 1 year
|
|
Renal and urinary disorders
hematuria
|
11.1%
1/9 • Number of events 1 • 1 year
|
0.00%
0/21 • 1 year
|
|
Eye disorders
hordeolum lower eyelid
|
11.1%
1/9 • Number of events 1 • 1 year
|
0.00%
0/21 • 1 year
|
|
Metabolism and nutrition disorders
hypokalemia
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Endocrine disorders
hypothyroidism
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Eye disorders
increased intraocular pressure
|
22.2%
2/9 • Number of events 2 • 1 year
|
28.6%
6/21 • Number of events 8 • 1 year
|
|
Infections and infestations
infection of toe
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Eye disorders
iritis
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Eye disorders
keratitis
|
0.00%
0/9 • 1 year
|
9.5%
2/21 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
knee pain
|
0.00%
0/9 • 1 year
|
9.5%
2/21 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
loss of blood sugar control
|
11.1%
1/9 • Number of events 1 • 1 year
|
23.8%
5/21 • Number of events 5 • 1 year
|
|
Musculoskeletal and connective tissue disorders
low back bain
|
0.00%
0/9 • 1 year
|
9.5%
2/21 • Number of events 2 • 1 year
|
|
Eye disorders
low tension glaucoma
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Eye disorders
macular scar
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
magnesium deficiency
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Infections and infestations
nail fungus
|
0.00%
0/9 • 1 year
|
9.5%
2/21 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
11.1%
1/9 • Number of events 1 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Eye disorders
neovascularization of retina
|
33.3%
3/9 • Number of events 3 • 1 year
|
4.8%
1/21 • Number of events 2 • 1 year
|
|
Cardiac disorders
peripheral vascular insufficiency
|
11.1%
1/9 • Number of events 1 • 1 year
|
0.00%
0/21 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.00%
0/9 • 1 year
|
14.3%
3/21 • Number of events 4 • 1 year
|
|
Infections and infestations
poison ivy
|
11.1%
1/9 • Number of events 1 • 1 year
|
0.00%
0/21 • 1 year
|
|
Eye disorders
posterior capsule opacification
|
0.00%
0/9 • 1 year
|
28.6%
6/21 • Number of events 6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
heel discomfort
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
laceration right leg
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Nervous system disorders
sciatica
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Infections and infestations
sinusitis
|
0.00%
0/9 • 1 year
|
23.8%
5/21 • Number of events 5 • 1 year
|
|
Musculoskeletal and connective tissue disorders
sleep apnea
|
11.1%
1/9 • Number of events 1 • 1 year
|
9.5%
2/21 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
ankle sprain
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Eye disorders
subconjunctival hemorrhage
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Eye disorders
tear film insufficiency
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
tendonitis
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Infections and infestations
foot ulcer
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
22.2%
2/9 • Number of events 2 • 1 year
|
9.5%
2/21 • Number of events 2 • 1 year
|
|
Ear and labyrinth disorders
vertigo
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Eye disorders
visual disturbance
|
11.1%
1/9 • Number of events 1 • 1 year
|
0.00%
0/21 • 1 year
|
|
Metabolism and nutrition disorders
vitamin D deficiency
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Eye disorders
vitreous hemorrhage
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Eye disorders
worsening of cataract
|
77.8%
7/9 • Number of events 7 • 1 year
|
38.1%
8/21 • Number of events 8 • 1 year
|
|
Cardiac disorders
worsening of coronary artery disease
|
11.1%
1/9 • Number of events 1 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Endocrine disorders
worsening of diabetes mellitus
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Cardiac disorders
worsening of hypertension
|
0.00%
0/9 • 1 year
|
19.0%
4/21 • Number of events 4 • 1 year
|
|
Cardiac disorders
worsening of peripheral vascular disease
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Eye disorders
worsening of posterior capsule opacification
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Eye disorders
worsening of vitreoretinal traction
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Eye disorders
worsening of vitreous hemorrhage
|
0.00%
0/9 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place