Trial Outcomes & Findings for Dexamethasone Intravitreal Implant for the Treatment of Persistent Diabetic Macular Edema (NCT NCT02471651)
NCT ID: NCT02471651
Last Updated: 2019-02-19
Results Overview
Mean change in central 1 mm sub-field thickness between baseline and 9 months as measured by Spectral Domain Optical Coherence Tomography (SDOCT).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
baseline and 9 months
Results posted on
2019-02-19
Participant Flow
Participant milestones
| Measure |
Implant
Subjects randomized to dexamethasone intravitreal implant (0.7mg) will receive the initial treatment at Month 3 (visit 4) and Month 6 (visit 7) and are eligible to receive one additional dose at Month 9 (visit 10), Month 10 (visit 11) or Month 11 (visit 12) for persistent or recurrent macular edema documented on SDOCT. If dexamethasone intravitreal implant (0.7mg) is administered at Month 10 (visit 11) or Month 11 (visit 12) an additional safety study visit will be required at one to two months following Month 12 (visit 13). The investigator can withhold treatment with dexamethasone intravitreal implant (0.7mg) beginning at Month 9 if there is complete resolution of diabetic macular edema document on SDOCT.
Dexamethasone intravitreal implant (0.7 mg): Subjects with persistent DME who are randomized to this arm may get up to 3 treatments with the implant (0.7 mg dexamethasone).
|
Intravitreal Anti-VEGF Injection
Subjects randomized to continue on anti-vegf therapy will receive intravitreal anti-vegf injections at Month 3 (visit 4) Month 4 (visit 5) and Month 5 (visit 6). Beginning at Month 6 (visit 7), subjects who have received 6 intravitreal anti-vegf injections and continue to present with persistent diabetic macular edema defined as less than 10% reduction or any increase in CST compared to baseline values and CST is greater than 300 microns, will receive dexamethasone intravitreal implant (0.7mg) at Month 6 (visit 7) and Month 9 (visit 10). The follow-up period for all subjects will continue through 12 months from the baseline study visit.
Intravitreal anti-VEGF injection: This injection may be ranibizumab, bevacizumab, or aflibercept.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age assessment was done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
Baseline characteristics by cohort
| Measure |
Implant
n=20 Participants
Subjects randomized to dexamethasone intravitreal implant (0.7mg) will receive the initial treatment at Month 3 (visit 4) and Month 6 (visit 7) and are eligible to receive one additional dose at Month 9 (visit 10), Month 10 (visit 11) or Month 11 (visit 12) for persistent or recurrent macular edema documented on SDOCT. If dexamethasone intravitreal implant (0.7mg) is administered at Month 10 (visit 11) or Month 11 (visit 12) an additional safety study visit will be required at one to two months following Month 12 (visit 13). The investigator can withhold treatment with dexamethasone intravitreal implant (0.7mg) beginning at Month 9 if there is complete resolution of diabetic macular edema document on SDOCT.
Dexamethasone intravitreal implant (0.7 mg): Subjects with persistent DME who are randomized to this arm may get up to 3 treatments with the implant (0.7 mg dexamethasone).
|
Intravitreal Anti-VEGF Injection
n=20 Participants
Subjects randomized to continue on anti-vegf therapy will receive intravitreal anti-vegf injections at Month 3 (visit 4) Month 4 (visit 5) and Month 5 (visit 6). Beginning at Month 6 (visit 7), subjects who have received 6 intravitreal anti-vegf injections and continue to present with persistent diabetic macular edema defined as less than 10% reduction or any increase in CST compared to baseline values and CST is greater than 300 microns, will receive dexamethasone intravitreal implant (0.7mg) at Month 6 (visit 7) and Month 9 (visit 10). The follow-up period for all subjects will continue through 12 months from the baseline study visit.
Intravitreal anti-VEGF injection: This injection may be ranibizumab, bevacizumab, or aflibercept.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 8 • n=15 Participants • Age assessment was done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
65 years
STANDARD_DEVIATION 7 • n=15 Participants • Age assessment was done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
63 years
STANDARD_DEVIATION 8 • n=30 Participants • Age assessment was done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
|
Sex: Female, Male
Female
|
7 Participants
n=15 Participants • Gender assessment was done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
8 Participants
n=15 Participants • Gender assessment was done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
15 Participants
n=30 Participants • Gender assessment was done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
|
Sex: Female, Male
Male
|
8 Participants
n=15 Participants • Gender assessment was done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
7 Participants
n=15 Participants • Gender assessment was done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
15 Participants
n=30 Participants • Gender assessment was done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=15 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
7 Participants
n=15 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
14 Participants
n=30 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=15 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
8 Participants
n=15 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
16 Participants
n=30 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
0 Participants
n=15 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
0 Participants
n=30 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
0 Participants
n=15 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
0 Participants
n=30 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=15 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
0 Participants
n=15 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
0 Participants
n=30 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=15 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
0 Participants
n=15 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
1 Participants
n=30 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=15 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
0 Participants
n=15 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
0 Participants
n=30 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
|
Race (NIH/OMB)
White
|
14 Participants
n=15 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
15 Participants
n=15 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
29 Participants
n=30 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
0 Participants
n=15 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
0 Participants
n=30 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
0 Participants
n=15 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
0 Participants
n=30 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
|
Region of Enrollment
United States
|
15 participants
n=15 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
15 participants
n=15 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
30 participants
n=30 Participants • Assessments were done for subjects who completed the study; subjects who were dropped from the study prior to their month 12 visit were not analyzed.
|
PRIMARY outcome
Timeframe: baseline and 9 monthsMean change in central 1 mm sub-field thickness between baseline and 9 months as measured by Spectral Domain Optical Coherence Tomography (SDOCT).
Outcome measures
| Measure |
Implant
n=15 Participants
Subjects randomized to dexamethasone intravitreal implant (0.7mg) will receive the initial treatment at Month 3 (visit 4) and Month 6 (visit 7) and are eligible to receive one additional dose at Month 9 (visit 10), Month 10 (visit 11) or Month 11 (visit 12) for persistent or recurrent macular edema documented on SDOCT. If dexamethasone intravitreal implant (0.7mg) is administered at Month 10 (visit 11) or Month 11 (visit 12) an additional safety study visit will be required at one to two months following Month 12 (visit 13). The investigator can withhold treatment with dexamethasone intravitreal implant (0.7mg) beginning at Month 9 if there is complete resolution of diabetic macular edema document on SDOCT.
Dexamethasone intravitreal implant (0.7 mg): Subjects with persistent DME who are randomized to this arm may get up to 3 treatments with the implant (0.7 mg dexamethasone).
|
Intravitreal Anti-VEGF Injection
n=15 Participants
Subjects randomized to continue on anti-vegf therapy will receive intravitreal anti-vegf injections at Month 3 (visit 4) Month 4 (visit 5) and Month 5 (visit 6). Beginning at Month 6 (visit 7), subjects who have received 6 intravitreal anti-vegf injections and continue to present with persistent diabetic macular edema defined as less than 10% reduction or any increase in CST compared to baseline values and CST is greater than 300 microns, will receive dexamethasone intravitreal implant (0.7mg) at Month 6 (visit 7) and Month 9 (visit 10). The follow-up period for all subjects will continue through 12 months from the baseline study visit.
Intravitreal anti-VEGF injection: This injection may be ranibizumab, bevacizumab, or aflibercept.
|
|---|---|---|
|
Mean Change in Central 1 mm Subfield Thickness Between Baseline and 9 Months
|
-51 millimeters
Standard Deviation 117
|
-60 millimeters
Standard Deviation 149
|
SECONDARY outcome
Timeframe: baseline and 9 monthsMean change in standardized best-corrected visual acuity between baseline and 9 months as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) testing. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified
Outcome measures
| Measure |
Implant
n=15 Participants
Subjects randomized to dexamethasone intravitreal implant (0.7mg) will receive the initial treatment at Month 3 (visit 4) and Month 6 (visit 7) and are eligible to receive one additional dose at Month 9 (visit 10), Month 10 (visit 11) or Month 11 (visit 12) for persistent or recurrent macular edema documented on SDOCT. If dexamethasone intravitreal implant (0.7mg) is administered at Month 10 (visit 11) or Month 11 (visit 12) an additional safety study visit will be required at one to two months following Month 12 (visit 13). The investigator can withhold treatment with dexamethasone intravitreal implant (0.7mg) beginning at Month 9 if there is complete resolution of diabetic macular edema document on SDOCT.
Dexamethasone intravitreal implant (0.7 mg): Subjects with persistent DME who are randomized to this arm may get up to 3 treatments with the implant (0.7 mg dexamethasone).
|
Intravitreal Anti-VEGF Injection
n=15 Participants
Subjects randomized to continue on anti-vegf therapy will receive intravitreal anti-vegf injections at Month 3 (visit 4) Month 4 (visit 5) and Month 5 (visit 6). Beginning at Month 6 (visit 7), subjects who have received 6 intravitreal anti-vegf injections and continue to present with persistent diabetic macular edema defined as less than 10% reduction or any increase in CST compared to baseline values and CST is greater than 300 microns, will receive dexamethasone intravitreal implant (0.7mg) at Month 6 (visit 7) and Month 9 (visit 10). The follow-up period for all subjects will continue through 12 months from the baseline study visit.
Intravitreal anti-VEGF injection: This injection may be ranibizumab, bevacizumab, or aflibercept.
|
|---|---|---|
|
Mean Change in Standardized Best-corrected Visual Acuity (BCVA) Between Baseline and 9 Months
|
1.5 letters on the ETDRS scale
Standard Deviation 13
|
1.8 letters on the ETDRS scale
Standard Deviation 12
|
SECONDARY outcome
Timeframe: baseline and 9 monthsTotal number of treatments in each arm between baseline and 9 months.
Outcome measures
| Measure |
Implant
n=15 Participants
Subjects randomized to dexamethasone intravitreal implant (0.7mg) will receive the initial treatment at Month 3 (visit 4) and Month 6 (visit 7) and are eligible to receive one additional dose at Month 9 (visit 10), Month 10 (visit 11) or Month 11 (visit 12) for persistent or recurrent macular edema documented on SDOCT. If dexamethasone intravitreal implant (0.7mg) is administered at Month 10 (visit 11) or Month 11 (visit 12) an additional safety study visit will be required at one to two months following Month 12 (visit 13). The investigator can withhold treatment with dexamethasone intravitreal implant (0.7mg) beginning at Month 9 if there is complete resolution of diabetic macular edema document on SDOCT.
Dexamethasone intravitreal implant (0.7 mg): Subjects with persistent DME who are randomized to this arm may get up to 3 treatments with the implant (0.7 mg dexamethasone).
|
Intravitreal Anti-VEGF Injection
n=15 Participants
Subjects randomized to continue on anti-vegf therapy will receive intravitreal anti-vegf injections at Month 3 (visit 4) Month 4 (visit 5) and Month 5 (visit 6). Beginning at Month 6 (visit 7), subjects who have received 6 intravitreal anti-vegf injections and continue to present with persistent diabetic macular edema defined as less than 10% reduction or any increase in CST compared to baseline values and CST is greater than 300 microns, will receive dexamethasone intravitreal implant (0.7mg) at Month 6 (visit 7) and Month 9 (visit 10). The follow-up period for all subjects will continue through 12 months from the baseline study visit.
Intravitreal anti-VEGF injection: This injection may be ranibizumab, bevacizumab, or aflibercept.
|
|---|---|---|
|
Total Number of Treatments in Each Arm Between Baseline and 9 Months
|
43 injections
|
83 injections
|
Adverse Events
Implant
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Intravitreal Anti-VEGF Injection
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Implant
n=20 participants at risk
Subjects randomized to dexamethasone intravitreal implant (0.7mg) will receive the initial treatment at Month 3 (visit 4) and Month 6 (visit 7) and are eligible to receive one additional dose at Month 9 (visit 10), Month 10 (visit 11) or Month 11 (visit 12) for persistent or recurrent macular edema documented on SDOCT. If dexamethasone intravitreal implant (0.7mg) is administered at Month 10 (visit 11) or Month 11 (visit 12) an additional safety study visit will be required at one to two months following Month 12 (visit 13). The investigator can withhold treatment with dexamethasone intravitreal implant (0.7mg) beginning at Month 9 if there is complete resolution of diabetic macular edema document on SDOCT.
Dexamethasone intravitreal implant (0.7 mg): Subjects with persistent DME who are randomized to this arm may get up to 3 treatments with the implant (0.7 mg dexamethasone).
|
Intravitreal Anti-VEGF Injection
n=20 participants at risk
Subjects randomized to continue on anti-vegf therapy will receive intravitreal anti-vegf injections at Month 3 (visit 4) Month 4 (visit 5) and Month 5 (visit 6). Beginning at Month 6 (visit 7), subjects who have received 6 intravitreal anti-vegf injections and continue to present with persistent diabetic macular edema defined as less than 10% reduction or any increase in CST compared to baseline values and CST is greater than 300 microns, will receive dexamethasone intravitreal implant (0.7mg) at Month 6 (visit 7) and Month 9 (visit 10). The follow-up period for all subjects will continue through 12 months from the baseline study visit.
Intravitreal anti-VEGF injection: This injection may be ranibizumab, bevacizumab, or aflibercept.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin graft
|
5.0%
1/20 • Number of events 1 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
0.00%
0/20 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
|
Eye disorders
Rhegmatogenous Retinal Detachment
|
0.00%
0/20 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
5.0%
1/20 • Number of events 1 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
Other adverse events
| Measure |
Implant
n=20 participants at risk
Subjects randomized to dexamethasone intravitreal implant (0.7mg) will receive the initial treatment at Month 3 (visit 4) and Month 6 (visit 7) and are eligible to receive one additional dose at Month 9 (visit 10), Month 10 (visit 11) or Month 11 (visit 12) for persistent or recurrent macular edema documented on SDOCT. If dexamethasone intravitreal implant (0.7mg) is administered at Month 10 (visit 11) or Month 11 (visit 12) an additional safety study visit will be required at one to two months following Month 12 (visit 13). The investigator can withhold treatment with dexamethasone intravitreal implant (0.7mg) beginning at Month 9 if there is complete resolution of diabetic macular edema document on SDOCT.
Dexamethasone intravitreal implant (0.7 mg): Subjects with persistent DME who are randomized to this arm may get up to 3 treatments with the implant (0.7 mg dexamethasone).
|
Intravitreal Anti-VEGF Injection
n=20 participants at risk
Subjects randomized to continue on anti-vegf therapy will receive intravitreal anti-vegf injections at Month 3 (visit 4) Month 4 (visit 5) and Month 5 (visit 6). Beginning at Month 6 (visit 7), subjects who have received 6 intravitreal anti-vegf injections and continue to present with persistent diabetic macular edema defined as less than 10% reduction or any increase in CST compared to baseline values and CST is greater than 300 microns, will receive dexamethasone intravitreal implant (0.7mg) at Month 6 (visit 7) and Month 9 (visit 10). The follow-up period for all subjects will continue through 12 months from the baseline study visit.
Intravitreal anti-VEGF injection: This injection may be ranibizumab, bevacizumab, or aflibercept.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/20 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
5.0%
1/20 • Number of events 1 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
|
Nervous system disorders
Pinched Nerve
|
0.00%
0/20 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
5.0%
1/20 • Number of events 1 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
|
General disorders
tooth ache
|
0.00%
0/20 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
5.0%
1/20 • Number of events 1 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
|
Eye disorders
High IOP
|
20.0%
4/20 • Number of events 5 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
5.0%
1/20 • Number of events 1 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
|
Eye disorders
Eye Pain
|
5.0%
1/20 • Number of events 1 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
10.0%
2/20 • Number of events 2 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
|
Eye disorders
active neovascularization
|
0.00%
0/20 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
5.0%
1/20 • Number of events 1 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
|
General disorders
flu
|
0.00%
0/20 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
10.0%
2/20 • Number of events 3 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
|
Blood and lymphatic system disorders
hypertension
|
5.0%
1/20 • Number of events 1 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
5.0%
1/20 • Number of events 1 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
|
Vascular disorders
Continuing/increased macular edema
|
0.00%
0/20 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
5.0%
1/20 • Number of events 3 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
|
Eye disorders
subconjunctival irritation
|
0.00%
0/20 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
5.0%
1/20 • Number of events 1 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
|
Vascular disorders
vitreous hemorrhage
|
0.00%
0/20 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
5.0%
1/20 • Number of events 2 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
|
General disorders
tooth being pulled
|
0.00%
0/20 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
5.0%
1/20 • Number of events 1 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
|
General disorders
cold/cough
|
20.0%
4/20 • Number of events 6 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
0.00%
0/20 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
|
General disorders
iron deficiency
|
5.0%
1/20 • Number of events 1 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
0.00%
0/20 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
|
General disorders
headache
|
5.0%
1/20 • Number of events 1 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
0.00%
0/20 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
|
Eye disorders
Blepharitis
|
5.0%
1/20 • Number of events 1 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
0.00%
0/20 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
|
Eye disorders
viral conjunctivitis
|
5.0%
1/20 • Number of events 1 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
0.00%
0/20 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
|
General disorders
leg injury
|
5.0%
1/20 • Number of events 1 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
0.00%
0/20 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
|
Eye disorders
eye itchiness
|
5.0%
1/20 • Number of events 1 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
0.00%
0/20 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
|
Infections and infestations
Toe infection
|
5.0%
1/20 • Number of events 1 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
0.00%
0/20 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
|
Eye disorders
dry eye
|
0.00%
0/20 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
5.0%
1/20 • Number of events 1 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
|
General disorders
general fatigue
|
0.00%
0/20 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
5.0%
1/20 • Number of events 1 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
|
Gastrointestinal disorders
stomach virus
|
0.00%
0/20 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
5.0%
1/20 • Number of events 1 • 12 months.
AEs and SAEs were monitored at every visit and recorded.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place