Trial Outcomes & Findings for Effect of Dexamethasone on Reduction of Macular Thickness in Diabetic Patients, a Randomized Clinical Trial (NCT NCT03608839)
NCT ID: NCT03608839
Last Updated: 2019-10-08
Results Overview
Measure macular thickness at 3 days after intravitreous dexamethasone with OCT - unit µm
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Three days after intravitreous dexamethasone
Results posted on
2019-10-08
Participant Flow
Data from DME diagnosed volunteers was collected and analyzed at the Department of Ophthalmology, State University of Campinas (UNICAMP), Brazil between May 2016 and December 2017
Informed written consent was obtained from all patients, and approved by the ethics committee of the Clinical Hospital of the State University of Campinas
Participant milestones
| Measure |
0,01ml Dexamethasone Solution
One intravitreous injection of 0,01 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml: 0,01 ml intravitreous dexamethasone solution 4mg/ml injection.
|
0,03 ml Dexamethasone Solution
One intravitreous injection of 0,03 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml: 0,03 ml intravitreous dexamethasone solution 4mg/ml injection.
|
0,05 ml Dexamethasone Solution
One intravitreous injection of 0,05 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml: 0,05 ml intravitreous dexamethasone solution 4mg/ml injection.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Dexamethasone on Reduction of Macular Thickness in Diabetic Patients, a Randomized Clinical Trial
Baseline characteristics by cohort
| Measure |
0,01ml Dexamethasone Solution
n=9 Participants
One intravitreous injection of 0,01 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml: 0,01 ml intravitreous dexamethasone solution 4mg/ml injection.
|
0,03 ml Dexamethasone Solution
n=9 Participants
One intravitreous injection of 0,03 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml: 0,03 ml intravitreous dexamethasone solution 4mg/ml injection.
|
0,05 ml Dexamethasone Solution
n=9 Participants
One intravitreous injection of 0,05 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml: 0,05 ml intravitreous dexamethasone solution 4mg/ml injection.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 5.63 • n=5 Participants
|
65.5 years
STANDARD_DEVIATION 8.26 • n=7 Participants
|
71.3 years
STANDARD_DEVIATION 7.36 • n=5 Participants
|
67.9 years
STANDARD_DEVIATION 7.33 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Brazil
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
27 participants
n=4 Participants
|
|
Eye (Right)
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Epirretinal membrane
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Subretinal fluid
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Microaneurysms in foveal region
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Posterior vitreous detachment
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Central macular thickness
|
527.6 µm
STANDARD_DEVIATION 154.21 • n=5 Participants
|
630 µm
STANDARD_DEVIATION 254.68 • n=7 Participants
|
453.3 µm
STANDARD_DEVIATION 140.39 • n=5 Participants
|
537.4 µm
STANDARD_DEVIATION 196.94 • n=4 Participants
|
|
Best corrected visual acuity
|
52.5 ETDRS Letters
STANDARD_DEVIATION 13.98 • n=5 Participants
|
47.2 ETDRS Letters
STANDARD_DEVIATION 19.31 • n=7 Participants
|
60 ETDRS Letters
STANDARD_DEVIATION 15.31 • n=5 Participants
|
53.2 ETDRS Letters
STANDARD_DEVIATION 16.61 • n=4 Participants
|
|
Intraocular pressure
|
11.8 mmHg
STANDARD_DEVIATION 2.02 • n=5 Participants
|
13.22 mmHg
STANDARD_DEVIATION 2.53 • n=7 Participants
|
11.6 mmHg
STANDARD_DEVIATION 2.55 • n=5 Participants
|
12.2 mmHg
STANDARD_DEVIATION 2.39 • n=4 Participants
|
PRIMARY outcome
Timeframe: Three days after intravitreous dexamethasonePopulation: Macular thickness at 3 days after intravitreous dexamethasone
Measure macular thickness at 3 days after intravitreous dexamethasone with OCT - unit µm
Outcome measures
| Measure |
0,01ml Dexamethasone Solution
n=9 Participants
One intravitreous injection of 0,01 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml: 0,01 ml intravitreous dexamethasone solution 4mg/ml injection.
|
0,03 ml Dexamethasone Solution
n=9 Participants
One intravitreous injection of 0,03 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml: 0,03 ml intravitreous dexamethasone solution 4mg/ml injection.
|
0,05 ml Dexamethasone Solution
n=9 Participants
One intravitreous injection of 0,05 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml: 0,05 ml intravitreous dexamethasone solution 4mg/ml injection.
|
|---|---|---|---|
|
Macular Thickness at 3 Days After Intravitreous Dexamethasone
|
438.44 µm
Standard Deviation 124.55
|
465.22 µm
Standard Deviation 115.25
|
368.22 µm
Standard Deviation 126.92
|
SECONDARY outcome
Timeframe: 28 days after intravitreous dexamethasoneMeasure macular thickness at 28 days after intravitreous dexamethasone with OCT - unit µm
Outcome measures
| Measure |
0,01ml Dexamethasone Solution
n=9 Participants
One intravitreous injection of 0,01 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml: 0,01 ml intravitreous dexamethasone solution 4mg/ml injection.
|
0,03 ml Dexamethasone Solution
n=9 Participants
One intravitreous injection of 0,03 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml: 0,03 ml intravitreous dexamethasone solution 4mg/ml injection.
|
0,05 ml Dexamethasone Solution
n=9 Participants
One intravitreous injection of 0,05 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml: 0,05 ml intravitreous dexamethasone solution 4mg/ml injection.
|
|---|---|---|---|
|
Macular Thickness at 28 Days After Intravitreous Dexamethasone
|
554.66 µm
Standard Deviation 175.91
|
617.22 µm
Standard Deviation 245.83
|
451.44 µm
Standard Deviation 154.48
|
SECONDARY outcome
Timeframe: Three days after intravitreous dexamethasoneMeasure best corrected visual acuity (BCVA) at 3 days after intravitreous dexamethasone with ETDRS chart
Outcome measures
| Measure |
0,01ml Dexamethasone Solution
n=9 Participants
One intravitreous injection of 0,01 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml: 0,01 ml intravitreous dexamethasone solution 4mg/ml injection.
|
0,03 ml Dexamethasone Solution
n=9 Participants
One intravitreous injection of 0,03 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml: 0,03 ml intravitreous dexamethasone solution 4mg/ml injection.
|
0,05 ml Dexamethasone Solution
n=9 Participants
One intravitreous injection of 0,05 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml: 0,05 ml intravitreous dexamethasone solution 4mg/ml injection.
|
|---|---|---|---|
|
Best Corrected Visual Acuity (BCVA) at 3 Days After Intravitreous Dexamethasone
|
54.22 ETDRS Letters
Standard Deviation 12.77
|
52.33 ETDRS Letters
Standard Deviation 16.09
|
60.22 ETDRS Letters
Standard Deviation 17.28
|
SECONDARY outcome
Timeframe: 28 days after intravitreous dexamethasoneMeasure best corrected visual acuity (BCVA) at 28 days after intravitreous dexamethasone with ETDRS chart
Outcome measures
| Measure |
0,01ml Dexamethasone Solution
n=9 Participants
One intravitreous injection of 0,01 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml: 0,01 ml intravitreous dexamethasone solution 4mg/ml injection.
|
0,03 ml Dexamethasone Solution
n=9 Participants
One intravitreous injection of 0,03 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml: 0,03 ml intravitreous dexamethasone solution 4mg/ml injection.
|
0,05 ml Dexamethasone Solution
n=9 Participants
One intravitreous injection of 0,05 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml: 0,05 ml intravitreous dexamethasone solution 4mg/ml injection.
|
|---|---|---|---|
|
Best Corrected Visual Acuity (BCVA) at 28 Days After Intravitreous Dexamethasone
|
58.33 ETDRS letters
Standard Deviation 15.46
|
50.55 ETDRS letters
Standard Deviation 18.51
|
64.11 ETDRS letters
Standard Deviation 16.01
|
SECONDARY outcome
Timeframe: 3 days after intravitreous dexamethasoneMeasure intraocular pressure (IOP) 3 days after intravitreous dexamethasone - unit mmHg
Outcome measures
| Measure |
0,01ml Dexamethasone Solution
n=9 Participants
One intravitreous injection of 0,01 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml: 0,01 ml intravitreous dexamethasone solution 4mg/ml injection.
|
0,03 ml Dexamethasone Solution
n=9 Participants
One intravitreous injection of 0,03 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml: 0,03 ml intravitreous dexamethasone solution 4mg/ml injection.
|
0,05 ml Dexamethasone Solution
n=9 Participants
One intravitreous injection of 0,05 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml: 0,05 ml intravitreous dexamethasone solution 4mg/ml injection.
|
|---|---|---|---|
|
Intraocular Pressure (IOP) at 3 Days After Intravitreous Dexamethasone
|
12.33 mmHg
Standard Deviation 3.90
|
13.11 mmHg
Standard Deviation 2.42
|
12.44 mmHg
Standard Deviation 3.97
|
SECONDARY outcome
Timeframe: 28 days after intravitreous dexamethasoneMeasure intraocular pressure (IOP) 28 days intravitreous dexamethasone - unit mmHg
Outcome measures
| Measure |
0,01ml Dexamethasone Solution
n=9 Participants
One intravitreous injection of 0,01 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml: 0,01 ml intravitreous dexamethasone solution 4mg/ml injection.
|
0,03 ml Dexamethasone Solution
n=9 Participants
One intravitreous injection of 0,03 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml: 0,03 ml intravitreous dexamethasone solution 4mg/ml injection.
|
0,05 ml Dexamethasone Solution
n=9 Participants
One intravitreous injection of 0,05 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml: 0,05 ml intravitreous dexamethasone solution 4mg/ml injection.
|
|---|---|---|---|
|
Intraocular Pressure (IOP) at 28 Days After Intravitreous Dexamethasone
|
12.33 mmHg
Standard Deviation 3.16
|
12.44 mmHg
Standard Deviation 2.74
|
11.88 mmHg
Standard Deviation 2.80
|
Adverse Events
0,01ml Dexamethasone Solution
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
0,03 ml Dexamethasone Solution
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
0,05 ml Dexamethasone Solution
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0,01ml Dexamethasone Solution
n=9 participants at risk
One intravitreous injection of 0,01 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml: 0,01 ml intravitreous dexamethasone solution 4mg/ml injection.
|
0,03 ml Dexamethasone Solution
n=9 participants at risk
One intravitreous injection of 0,03 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml: 0,03 ml intravitreous dexamethasone solution 4mg/ml injection.
|
0,05 ml Dexamethasone Solution
n=9 participants at risk
One intravitreous injection of 0,05 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml: 0,05 ml intravitreous dexamethasone solution 4mg/ml injection.
|
|---|---|---|---|
|
Eye disorders
Endophthalmitis
|
0.00%
0/9 • Adverse event data were collected during the study period - 28 days.
Dexamethasone solution 4mg/ml used in the study does not have impact in cardiovascular events.
|
0.00%
0/9 • Adverse event data were collected during the study period - 28 days.
Dexamethasone solution 4mg/ml used in the study does not have impact in cardiovascular events.
|
0.00%
0/9 • Adverse event data were collected during the study period - 28 days.
Dexamethasone solution 4mg/ml used in the study does not have impact in cardiovascular events.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/9 • Adverse event data were collected during the study period - 28 days.
Dexamethasone solution 4mg/ml used in the study does not have impact in cardiovascular events.
|
0.00%
0/9 • Adverse event data were collected during the study period - 28 days.
Dexamethasone solution 4mg/ml used in the study does not have impact in cardiovascular events.
|
0.00%
0/9 • Adverse event data were collected during the study period - 28 days.
Dexamethasone solution 4mg/ml used in the study does not have impact in cardiovascular events.
|
Other adverse events
| Measure |
0,01ml Dexamethasone Solution
n=9 participants at risk
One intravitreous injection of 0,01 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml: 0,01 ml intravitreous dexamethasone solution 4mg/ml injection.
|
0,03 ml Dexamethasone Solution
n=9 participants at risk
One intravitreous injection of 0,03 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml: 0,03 ml intravitreous dexamethasone solution 4mg/ml injection.
|
0,05 ml Dexamethasone Solution
n=9 participants at risk
One intravitreous injection of 0,05 ml dexamethasone solution 4 mg/ml.
Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml: 0,05 ml intravitreous dexamethasone solution 4mg/ml injection.
|
|---|---|---|---|
|
Eye disorders
Intraocular pressure elevation (IOP) > 5 mmHg from baseline
|
0.00%
0/9 • Adverse event data were collected during the study period - 28 days.
Dexamethasone solution 4mg/ml used in the study does not have impact in cardiovascular events.
|
0.00%
0/9 • Adverse event data were collected during the study period - 28 days.
Dexamethasone solution 4mg/ml used in the study does not have impact in cardiovascular events.
|
0.00%
0/9 • Adverse event data were collected during the study period - 28 days.
Dexamethasone solution 4mg/ml used in the study does not have impact in cardiovascular events.
|
Additional Information
Dr Rodrigo Pessoa Cavalcanti Lira
State University of Campinas (UNICAMP)
Phone: 551935217396
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place