Trial Outcomes & Findings for Ozurdex for Retinal Vein Occlusion Study (ORVO Study) (NCT NCT01790685)
NCT ID: NCT01790685
Last Updated: 2015-04-22
Results Overview
Vasoactive protein arrays and Enzyme linked immunosorbent assays were done for patients at baseline and week 4 visit to measure the levels of various pro-permeability factors including VEGF, SDF-1 and Angiopoietin-2.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
40 participants
Primary outcome timeframe
4 months
Results posted on
2015-04-22
Participant Flow
40 patients from the clinic population of the Wilmer Eye Institute were recruited,
Participant milestones
| Measure |
CRVO
Central Retinal Vein Occlusion
dexamethasone implant
|
BRVO
Branch Retinal Vein Occlusion
dexamethasone implant
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
17
|
|
Overall Study
COMPLETED
|
23
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ozurdex for Retinal Vein Occlusion Study (ORVO Study)
Baseline characteristics by cohort
| Measure |
CRVO
n=23 Participants
Central Retinal Vein Occlusion
dexamethasone implant
|
BRVO
n=17 Participants
Branch Retinal Vein Occlusion
dexamethasone implant
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74 years
n=5 Participants
|
72 years
n=7 Participants
|
73 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: All enrolled (23 CRVO and 17 BRVO) patients completed the study. All patients were injected with Ozurdex, however microarrays were run on only 11 CRVO and 17 BRVO patient samples. Microarray data from 11 CRVO and 11 BRVO patients was analyzed.
Vasoactive protein arrays and Enzyme linked immunosorbent assays were done for patients at baseline and week 4 visit to measure the levels of various pro-permeability factors including VEGF, SDF-1 and Angiopoietin-2.
Outcome measures
| Measure |
CRVO
n=11 Participants
Central Retinal Vein Occlusion
dexamethasone implant
|
BRVO
n=11 Participants
Branch Retinal Vein Occlusion
dexamethasone implant
|
|---|---|---|
|
Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex
IGF-BP3
|
7 participants
|
6 participants
|
|
Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex
Endostatin
|
7 participants
|
6 participants
|
|
Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex
HGF
|
7 participants
|
5 participants
|
|
Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex
EG-VEGF
|
7 participants
|
4 participants
|
|
Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex
Activin-A
|
4 participants
|
6 participants
|
|
Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex
IGFBP-1
|
7 participants
|
4 participants
|
|
Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex
IGFBP-2
|
7 participants
|
6 participants
|
Adverse Events
CRVO
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
BRVO
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CRVO
n=23 participants at risk
Central Retinal Vein Occlusion
dexamethasone implant
|
BRVO
n=17 participants at risk
Branch Retinal Vein Occlusion
dexamethasone implant
|
|---|---|---|
|
Injury, poisoning and procedural complications
Patient fell down the stairs and was hospitalized for a cerebral bleed.
|
4.3%
1/23 • Number of events 1
|
0.00%
0/17
|
|
Infections and infestations
The patient was hospitalized for an infection
|
0.00%
0/23
|
5.9%
1/17 • Number of events 1
|
|
Injury, poisoning and procedural complications
Patient fell and hit head on the back of a chair resulting in trauma and infection in the study eye
|
0.00%
0/23
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
The patient was hospitalized for stomach pain
|
0.00%
0/23
|
5.9%
1/17 • Number of events 1
|
Other adverse events
| Measure |
CRVO
n=23 participants at risk
Central Retinal Vein Occlusion
dexamethasone implant
|
BRVO
n=17 participants at risk
Branch Retinal Vein Occlusion
dexamethasone implant
|
|---|---|---|
|
Eye disorders
Increase in IOP in study eye
|
13.0%
3/23 • Number of events 3
|
17.6%
3/17 • Number of events 3
|
|
Eye disorders
Redness of study eye after drug injection
|
8.7%
2/23 • Number of events 2
|
11.8%
2/17 • Number of events 2
|
|
General disorders
Patient had an uneventful fall
|
13.0%
3/23 • Number of events 3
|
0.00%
0/17
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There is a restriction on the PI regarding disclosure of study results, which will be updated once the manuscript is published.
- Publication restrictions are in place
Restriction type: OTHER