Trial Outcomes & Findings for Diabetic Macular Edema Treated With Ozurdex (DMEO) (NCT NCT01951066)
NCT ID: NCT01951066
Last Updated: 2016-09-29
Results Overview
Changes in propermeability factor levels were correlated with changes in edema using the person correlation coefficient (this was calculated using data from all time points).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
1, 2, 3, and 4 months after injection of a dexamethasone implant or anti-VEGF agent
Results posted on
2016-09-29
Participant Flow
Participant milestones
| Measure |
Group 1 (Dexamethasone Implant/Anti-VEGF)
Patients in group 1 received an injection of an dexamethasone implant at baseline followed by PRN anti-VEGF injections after crossover at week 16.
Dexamethasone Implant: Patients will receive a single injection of a dexmethasone implant
Anti-VEGF injection: Patients will receive PRN injections of an anti-VEGF agent
|
Group 2 (Anti-VEGF/Dexamethasone Implant)
Patients in group 2 received prn anti-VEGF injections followed by injection of a dexamethasone implant after crossover at week 16.
Dexamethasone Implant: Patients will receive a single injection of a dexmethasone implant
Anti-VEGF injection: Patients will receive PRN injections of an anti-VEGF agent
|
|---|---|---|
|
First Intervention (Baseline to Week 16)
STARTED
|
10
|
10
|
|
First Intervention (Baseline to Week 16)
COMPLETED
|
10
|
10
|
|
First Intervention (Baseline to Week 16)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (Week 16 to Week 32)
STARTED
|
10
|
10
|
|
Second Intervention (Week 16 to Week 32)
COMPLETED
|
10
|
10
|
|
Second Intervention (Week 16 to Week 32)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Diabetic Macular Edema Treated With Ozurdex (DMEO)
Baseline characteristics by cohort
| Measure |
All Participants
n=20 Participants
|
|---|---|
|
Age, Continuous
|
61.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Baseline Intraretinal Fluid
Mild
|
3 participants
n=5 Participants
|
|
Baseline Intraretinal Fluid
Moderate
|
14 participants
n=5 Participants
|
|
Baseline Intraretinal Fluid
Severe
|
3 participants
n=5 Participants
|
|
Mean Disease Duration
|
48.1 Months
n=5 Participants
|
|
Prior Anti-VEGF injections
|
13.3 Injections
n=5 Participants
|
|
Prior Intraocular Steroids
|
5 participants
n=5 Participants
|
|
Prior Laser
Grid Laser
|
6 participants
n=5 Participants
|
|
Prior Laser
Scatter Laser Photocoagulation
|
6 participants
n=5 Participants
|
|
Baseline Best Corrected Visual Acuity
|
56.1 ETDRS Score
n=5 Participants
|
|
Baseline Central Subfield Thickness
|
464.3 Microns
n=5 Participants
|
PRIMARY outcome
Timeframe: 1, 2, 3, and 4 months after injection of a dexamethasone implant or anti-VEGF agentChanges in propermeability factor levels were correlated with changes in edema using the person correlation coefficient (this was calculated using data from all time points).
Outcome measures
| Measure |
Dexamethasone Implant
n=20 Participants
Patients received an injection of an dexamethasone implant
|
Anti-VEGF Agent
n=20 Participants
Patients received PRN injections of an Anti-VEGF agent
|
|---|---|---|
|
Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent
THSP-2
|
0.33 Pearson correlation coefficient (r)
|
0.064 Pearson correlation coefficient (r)
|
|
Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent
HGF
|
0.31 Pearson correlation coefficient (r)
|
0.226 Pearson correlation coefficient (r)
|
|
Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent
IL-8
|
0.30 Pearson correlation coefficient (r)
|
-0.184 Pearson correlation coefficient (r)
|
|
Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent
MIP-1a
|
0.34 Pearson correlation coefficient (r)
|
-0.107 Pearson correlation coefficient (r)
|
|
Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent
Angiopoietin-2
|
0.40 Pearson correlation coefficient (r)
|
0.229 Pearson correlation coefficient (r)
|
|
Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent
IGF-BP3
|
0.36 Pearson correlation coefficient (r)
|
0.435 Pearson correlation coefficient (r)
|
|
Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent
Persephin
|
0.35 Pearson correlation coefficient (r)
|
0.114 Pearson correlation coefficient (r)
|
|
Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent
IGF-BP1
|
0.47 Pearson correlation coefficient (r)
|
0.059 Pearson correlation coefficient (r)
|
|
Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent
Prolactin
|
0.45 Pearson correlation coefficient (r)
|
0.369 Pearson correlation coefficient (r)
|
|
Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent
MMP-9
|
0.45 Pearson correlation coefficient (r)
|
0.29 Pearson correlation coefficient (r)
|
|
Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent
EG-VEGF
|
0.43 Pearson correlation coefficient (r)
|
-0.004 Pearson correlation coefficient (r)
|
|
Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent
Endostatin
|
0.41 Pearson correlation coefficient (r)
|
0.189 Pearson correlation coefficient (r)
|
|
Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent
CXCL16
|
0.29 Pearson correlation coefficient (r)
|
0.027 Pearson correlation coefficient (r)
|
Adverse Events
All Participants
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Participants
n=20 participants at risk
|
|---|---|
|
Eye disorders
Cataract progression
|
5.0%
1/20
|
|
Nervous system disorders
Emergency room visit because of a possible seizure
|
5.0%
1/20
|
|
Cardiac disorders
Mitral valve repair surgery
|
5.0%
1/20
|
|
Eye disorders
Endophthalmitis
|
5.0%
1/20
|
Other adverse events
| Measure |
All Participants
n=20 participants at risk
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Steroid injection in the hip due to arthritis
|
5.0%
1/20
|
|
Cardiac disorders
Racing of heart
|
5.0%
1/20
|
|
Musculoskeletal and connective tissue disorders
Foot Infection
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.0%
1/20
|
|
Eye disorders
Vision loss
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20
|
|
General disorders
Patient had a fall
|
10.0%
2/20
|
|
Eye disorders
Increased Intraocular pressure
|
5.0%
1/20
|
|
Eye disorders
Eye soreness
|
5.0%
1/20
|
|
Eye disorders
Bruising of eyelid
|
5.0%
1/20
|
|
Blood and lymphatic system disorders
Blood transfusion due to severe anemia
|
5.0%
1/20
|
Additional Information
[Peter A. Campochiaro
Wilmer Eye Institute, Johns Hopkins University School of Medicine
Phone: (410) 955-5106
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER