Trial Outcomes & Findings for Anti-Vascular Endothelial Growth Factor (Anti-VEGF) Alone Versus Ozurdex Given Every 3 Months for Treatment of Persistent Diabetic Macular Edema (NCT NCT02036424)
NCT ID: NCT02036424
Last Updated: 2015-12-01
Results Overview
Visual acuity was obtained using ETDRS method and the total number of letters correct using that method was used to calculate mean visual acuity change.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
45 participants
Primary outcome timeframe
baseline to month 7
Results posted on
2015-12-01
Participant Flow
Subjects were recruited from the PI's clinical practice from January 2014 through October 2014.
This trial had 50 study eyes from a total of 45 participants. 5 participants had both eyes in the study.
Participant milestones
| Measure |
Bevacizumab
1.25 mg intravitreal injection given monthly during a 6 month period
Bevacizumab: antiVEGF
|
Ozurdex
Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections
Ozurdex: intravitreal steroid
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
27
|
|
Overall Study
COMPLETED
|
23
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anti-Vascular Endothelial Growth Factor (Anti-VEGF) Alone Versus Ozurdex Given Every 3 Months for Treatment of Persistent Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
Bevacizumab
n=23 Participants
1.25 mg intravitreal injection given monthly during a 6 month period
Bevacizumab: antiVEGF
|
Ozurdex
n=27 Participants
Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections
Ozurdex: intravitreal steroid
|
Total
n=50 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
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 9 • n=5 Participants
|
65 years
STANDARD_DEVIATION 11 • n=7 Participants
|
63 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 study eyes
n=5 Participants
|
27 study eyes
n=7 Participants
|
50 study eyes
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to month 7Visual acuity was obtained using ETDRS method and the total number of letters correct using that method was used to calculate mean visual acuity change.
Outcome measures
| Measure |
Bevacizumab
n=23 eyes
1.25 mg intravitreal injection given monthly during a 6 month period
Bevacizumab: antiVEGF
|
Ozurdex
n=27 eyes
Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections
Ozurdex: intravitreal steroid
|
|---|---|---|
|
Mean Visual Acuity Change
|
5.6 ETDRS letters
Standard Deviation 6.1
|
5.8 ETDRS letters
Standard Deviation 7.6
|
PRIMARY outcome
Timeframe: baseline to month sevenOptical coherence tomography (OCT) is an established medical imaging technique that uses light to capture micrometer-resolution, three-dimensional images. The image is presented in grid form which divides that retina into sections. The center most section (CST) is used for this outcome measurement.
Outcome measures
| Measure |
Bevacizumab
n=23 study eyes
1.25 mg intravitreal injection given monthly during a 6 month period
Bevacizumab: antiVEGF
|
Ozurdex
n=27 study eyes
Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections
Ozurdex: intravitreal steroid
|
|---|---|---|
|
Change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) From Baseline to Month Seven
|
-13 microns
Standard Deviation 105
|
-122 microns
Standard Deviation 120
|
Adverse Events
Bevacizumab
Serious events: 7 serious events
Other events: 10 other events
Deaths: 0 deaths
Ozurdex
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab
n=23 participants at risk
1.25 mg intravitreal injection given monthly during a 6 month period
Bevacizumab: antiVEGF
|
Ozurdex
n=27 participants at risk；n=22 participants at risk
Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections
Ozurdex: intravitreal steroid
|
|---|---|---|
|
Eye disorders
vitreous hemorrhage
|
8.7%
2/23 • Number of events 2
Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
|
4.5%
1/22 • Number of events 1
Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
|
|
Eye disorders
cranial nerve VI palsy
|
4.3%
1/23 • Number of events 1
Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
|
0.00%
0/22
Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
|
|
Eye disorders
choroidal detachment
|
0.00%
0/23
Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
|
4.5%
1/22 • Number of events 1
Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
|
|
Cardiac disorders
bradycardia
|
4.3%
1/23 • Number of events 1
Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
|
0.00%
0/22
Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
4.3%
1/23 • Number of events 1
Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
|
0.00%
0/22
Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
|
|
Renal and urinary disorders
pyelonephritis
|
4.3%
1/23 • Number of events 1
Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
|
0.00%
0/22
Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
|
|
Gastrointestinal disorders
colon cancer
|
4.3%
1/23 • Number of events 1
Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
|
0.00%
0/22
Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
|
|
Cardiac disorders
congestive heart failure
|
0.00%
0/23
Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
|
4.5%
1/22 • Number of events 1
Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
|
Other adverse events
| Measure |
Bevacizumab
n=23 participants at risk
1.25 mg intravitreal injection given monthly during a 6 month period
Bevacizumab: antiVEGF
|
Ozurdex
n=27 participants at risk；n=22 participants at risk
Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections
Ozurdex: intravitreal steroid
|
|---|---|---|
|
Eye disorders
epiretinal membrane
|
0.00%
0/23
Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
|
7.4%
2/27 • Number of events 2
Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
|
|
Eye disorders
vitreous syneresis
|
8.7%
2/23 • Number of events 2
Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
|
11.1%
3/27 • Number of events 3
Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
|
|
Eye disorders
posterior capsule opacification
|
8.7%
2/23 • Number of events 2
Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
|
14.8%
4/27 • Number of events 4
Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
|
|
Eye disorders
vitreous hemorrhage
|
21.7%
5/23 • Number of events 5
Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
|
7.4%
2/27 • Number of events 2
Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
|
|
Eye disorders
worsening of cataract
|
17.4%
4/23 • Number of events 4
Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
|
25.9%
7/27 • Number of events 7
Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
|
|
Eye disorders
increased intraocular pressure
|
0.00%
0/23
Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
|
51.9%
14/27 • Number of events 14
Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place