Trial Outcomes & Findings for Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO) (NCT NCT01231633)
NCT ID: NCT01231633
Last Updated: 2018-04-03
Results Overview
The change in visual acuity (number of ETDRS - Early Treatment Diabetic Retinopathy Study letters), at Month 6 as compared with baseline in each treatment arm
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
Baseline - Month 6
Results posted on
2018-04-03
Participant Flow
Participant milestones
| Measure |
Ozurdex & Avastin
Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.
Ozurdex: Ozurdex, 0.7mg dexamethasone
Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.
|
Avastin Only
Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.
Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
|
Overall Study
COMPLETED
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO)
Baseline characteristics by cohort
| Measure |
Group 1
n=14 Participants
Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.
Ozurdex: Ozurdex, 0.7mg dexamethasone
Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.
|
Group 2
n=13 Participants
Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.
Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.
|
Total
n=27 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
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Continuous
|
68.8 years
n=5 Participants
|
74.3 years
n=7 Participants
|
71.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline - Month 6The change in visual acuity (number of ETDRS - Early Treatment Diabetic Retinopathy Study letters), at Month 6 as compared with baseline in each treatment arm
Outcome measures
| Measure |
Group 1
n=14 Participants
Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.
Ozurdex: Ozurdex, 0.7mg dexamethasone
Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.
|
Group 2
n=13 Participants
Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.
Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.
|
|---|---|---|
|
The Change in Visual Acuity (Number of ETDRS Early Treatment Diabetic Retinopathy Study Letters), at Month 6 as Compared With Baseline in Each Treatment Arm
|
11.1 Letters Gain/Loss
Interval -7.0 to 38.0
|
16.1 Letters Gain/Loss
Interval -2.0 to 39.0
|
PRIMARY outcome
Timeframe: Baseline - Month 6Total Number of addiitonal Avastin injections during study- From baseline to Month 6
Outcome measures
| Measure |
Group 1
n=14 Participants
Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.
Ozurdex: Ozurdex, 0.7mg dexamethasone
Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.
|
Group 2
n=13 Participants
Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.
Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.
|
|---|---|---|
|
The Total Number of Additional Avastin Injections Following Initial Treatment in Each Treatment Arm
|
2.5 Injections
Interval 1.0 to 6.0
|
5.1 Injections
Interval 3.0 to 6.0
|
SECONDARY outcome
Timeframe: Baseline to 6 MonthsChange in Central Mean Thickness based on OCT from baseline to Month 6t
Outcome measures
| Measure |
Group 1
n=14 Participants
Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.
Ozurdex: Ozurdex, 0.7mg dexamethasone
Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.
|
Group 2
n=13 Participants
Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.
Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.
|
|---|---|---|
|
Change in Central Mean Thickness Based on OCT
Initial OCT Measure at Basline
|
703 Microns on OCT
Interval 344.0 to 1255.0
|
790 Microns on OCT
Interval 496.0 to 1183.0
|
|
Change in Central Mean Thickness Based on OCT
Final OCT measure at Month 6
|
353 Microns on OCT
Interval 189.0 to 605.0
|
408 Microns on OCT
Interval 149.0 to 710.0
|
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
Vincent A. Deramo, MD
Long Island Vitreoretinal Consultants
Phone: 5164660390
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place