Trial Outcomes & Findings for Effect of Ozurdex® 0.7 mg on Improvement of Efficacy of Bevacizumab for Central Retinal Vein Occlusion (NCT NCT01295112)
NCT ID: NCT01295112
Last Updated: 2025-09-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
68 participants
Primary outcome timeframe
24 weeks
Results posted on
2025-09-25
Participant Flow
A total of 68 participants ≥18 years of age with a diagnosis of central retinal vein occlusion (CRVO) as determined by fundus photography and fluorescein angiography were enrolled in the study at 5 clinical centers.
Participant milestones
| Measure |
Group 1
Active bevacizumab (Avastin®) and Sham Ozurdex®
Active bevacizumab and Sham dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe
|
Group 2
Active bevacizumab (Avastin®) and Active Ozurdex®
Active bevacizumab and Active dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
33
|
|
Overall Study
COMPLETED
|
35
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Ozurdex® 0.7 mg on Improvement of Efficacy of Bevacizumab for Central Retinal Vein Occlusion
Baseline characteristics by cohort
| Measure |
Group 1
n=35 Participants
Active bevacizumab (Avastin®) and Sham Ozurdex®
Active bevacizumab and Sham dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe
|
Group 2
n=33 Participants
Active bevacizumab (Avastin®) and Active Ozurdex®
Active bevacizumab and Active dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 15.0 • n=99 Participants
|
70.7 years
STANDARD_DEVIATION 12.6 • n=107 Participants
|
68.5 years
STANDARD_DEVIATION 14.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
25 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Previous Injections
Bevacizumab
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Previous Injections
No Injection
|
22 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Previous Injections
Ranibizumab
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Previous Injections
Bevacizumab and Ranibizumab
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Previous Injections
Bevacizumab and Aflibercept
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Study Eye
Right Eye
|
18 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Study Eye
Left Eye
|
17 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Baseline best corrected visual acuity (BCVA) in Study Eye
|
49.6 letters
STANDARD_DEVIATION 18.2 • n=99 Participants
|
55.7 letters
STANDARD_DEVIATION 17.2 • n=107 Participants
|
52.5 letters
STANDARD_DEVIATION 17.8 • n=206 Participants
|
|
Baselinen best corrected visual acuity (BCVA) in Fellow Eye
|
82.0 letters
STANDARD_DEVIATION 12.6 • n=99 Participants
|
82.2 letters
STANDARD_DEVIATION 9.6 • n=107 Participants
|
82.1 letters
STANDARD_DEVIATION 11.2 • n=206 Participants
|
|
Baseline Central Foveal Thickness in Study Eye
|
264.5 microns
STANDARD_DEVIATION 68.9 • n=99 Participants
|
262.1 microns
STANDARD_DEVIATION 70.0 • n=107 Participants
|
263.3 microns
STANDARD_DEVIATION 68.8 • n=206 Participants
|
|
Baseline Central Foveal Thickness in Fellow Eye
|
209.3 microns
STANDARD_DEVIATION 39.1 • n=99 Participants
|
213.1 microns
STANDARD_DEVIATION 35.6 • n=107 Participants
|
211.2 microns
STANDARD_DEVIATION 36.9 • n=206 Participants
|
PRIMARY outcome
Timeframe: 24 weeksOutcome measures
| Measure |
Group 1
n=35 Participants
Active bevacizumab (Avastin®) and Sham Ozurdex®
Active bevacizumab and Sham dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe
|
Group 2
n=33 Participants
Active bevacizumab (Avastin®) and Active Ozurdex®
Active bevacizumab and Active dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose
|
|---|---|---|
|
The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks
2 PRN Injections
|
10 Participants
|
3 Participants
|
|
The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks
0 PRN Injections
|
5 Participants
|
19 Participants
|
|
The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks
1 PRN Injection
|
13 Participants
|
11 Participants
|
|
The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks
3 PRN Injections
|
6 Participants
|
0 Participants
|
|
The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks
4 PRN Injections
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 weeksThe secondary efficacy endpoint is the visual acuity score based on best corrected visual acuity (BCVA) at Week 24 Change in BCVA at Week 24 from baseline
Outcome measures
| Measure |
Group 1
n=35 Participants
Active bevacizumab (Avastin®) and Sham Ozurdex®
Active bevacizumab and Sham dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe
|
Group 2
n=33 Participants
Active bevacizumab (Avastin®) and Active Ozurdex®
Active bevacizumab and Active dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose
|
|---|---|---|
|
The Secondary Efficacy Endpoint is the Visual Acuity Score Based on Best Corrected Visual Acuity (BCVA) at Week 24
|
16.20 letters
Standard Deviation 15.49
|
13.55 letters
Standard Deviation 19.41
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place