Trial Outcomes & Findings for Comparative Study of Dexamethasone Implant to Intravitreal Aflibercept in Subjects With Diabetic Macular Edema (NCT NCT04411693)
NCT ID: NCT04411693
Last Updated: 2026-07-29
Results Overview
It is defined as the mean change in the thickness between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) in the central 1mm. Discrepancy in total number relates to variable follow up for evaluation of change in parameter.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
23 participants
Primary outcome timeframe
6 months
Results posted on
2026-07-29
Participant Flow
Subjects will be given intravitreal aflibercept 2 mg (0.05 mL or 50 microliters) at run-in visit (run-in period is 1 month). If the DME resolves as determined by the investigator (e.g., complete resolution of foveal cystic changes), subjects will be exited from the study after completing the Month 0/Visit 1 encounter. If DME persists, the subject will be randomized between groups: Group A: Intravitreal dexamethasone implant and Group B: Intravitreal aflibercept (both given at month 0).
If participants had diabetic macular edema after the injection in the run-in period 4 weeks following the screening visit, they were then randomized to Group A or Group B. Participants were randomized at the subsequent month 1 visit. All 23 patients were enrolled though some had missing follow up visits resulting in discrepancy in the final outcome parameters sample size on various factors. All screened patients were enrolled resulting in matching enrollment and flow numbers.
Participant milestones
| Measure |
Group A: Intravitreal Dexamethasone Implant
Subjects in this arm will be given intravitreal Dexamethasone implant injection at month 0. PRN intravitreal Dexamethasone implant injections will be given for persistent edema, if it has been 10 weeks or more since last implant injection. If it has been less than 10 weeks since last implant injection, subjects will receive PRN intravitreal Aflibercept for persistent edema.
Dexamethasone implant: A sustained-release drug delivery system containing 0.7 mg of Dexamethasone. Implant is administered by intravitreal injection.
Aflibercept: A single dose, 2mg, drug administered by intravitreal injection.
|
Group B: Intravitreal Aflibercept
Subjects in this arm will be given Intravitreal aflibercept at month 0. PRN intravitreal Aflibercept will be given at months 1-6 for persistent edema.
Aflibercept: A single dose, 2mg, drug administered by intravitreal injection.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
13
|
|
Overall Study
Completed Sufficient for Analysis
|
10
|
11
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Study of Dexamethasone Implant to Intravitreal Aflibercept in Subjects With Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
Group A: Intravitreal Dexamethasone Implant
n=10 Participants
Subjects in this arm will be given intravitreal Dexamethasone implant injection at month 0. PRN intravitreal Dexamethasone implant injections will be given for persistent edema, if it has been 10 weeks or more since last implant injection. If it has been less than 10 weeks since last implant injection, subjects will receive PRN intravitreal Aflibercept for persistent edema.
Dexamethasone implant: A sustained-release drug delivery system containing 0.7 mg of Dexamethasone. Implant is administered by intravitreal injection.
Aflibercept: A single dose, 2mg, drug administered by intravitreal injection.
|
Group B: Intravitreal Aflibercept
n=11 Participants
Intravitreal aflibercept given at month 0. PRN intravitreal Aflibercept given at months 1-6 if foveal-involving DME persists.
Aflibercept: A single dose, 2mg, drug administered by intravitreal injection.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=9 Participants
|
11 Participants
n=27 Participants
|
21 Participants
n=267 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
13 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
12 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
9 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
9 Participants
n=267 Participants
|
|
Retinal-RPE (including Fluid) Volume (mm³)
|
12.07 mm3
STANDARD_DEVIATION 1.29 • n=9 Participants
|
11.80 mm3
STANDARD_DEVIATION 1.82 • n=27 Participants
|
11.93 mm3
STANDARD_DEVIATION 1.54 • n=267 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The data represents the change in microns at 6 months from initial treatment across both treatment arms. Any difference in group number from participant flow reflects variation in specific outcome measure follow up data availability due to image quality and variable follow up availability.
It is defined as the mean change in the thickness between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) in the central 1mm. Discrepancy in total number relates to variable follow up for evaluation of change in parameter.
Outcome measures
| Measure |
Group A: Intravitreal Dexamethasone Implant
n=9 Participants
Subjects in this arm will be given intravitreal Dexamethasone implant injection at month 0. PRN intravitreal Dexamethasone implant injections will be given for persistent edema, if it has been 10 weeks or more since last implant injection. If it has been less than 10 weeks since last implant injection, subjects will receive PRN intravitreal Aflibercept for persistent edema.
Dexamethasone implant: A sustained-release drug delivery system containing 0.7 mg of Dexamethasone. Implant is administered by intravitreal injection.
Aflibercept: A single dose, 2mg, drug administered by intravitreal injection.
|
Group B: Intravitreal Aflibercept
n=10 Participants
Subjects in this arm will be given Intravitreal aflibercept at month 0. PRN intravitreal Aflibercept will be given at months 1-6 for persistent edema.
Aflibercept: A single dose, 2mg, drug administered by intravitreal injection.
|
Group A Run in Period
Patients received an initial aflibercept injection as outlined in the methods. This group is the patients who were subsequently randomized into Group A for the treatment arms of the study. This includes AEs for only the run in period (of one injection of aflibercept)
|
Group B Run in Period
Patients received an initial aflibercept injection as outlined in the methods. This group is the patients who were subsequently randomized into Group B for the treatment arms of the study. This includes AEs for only the run in period (of one injection of aflibercept)
|
|---|---|---|---|---|
|
The Mean Change in Central Subfield Thickness
|
2.2 µm
Standard Deviation 6.6
|
4.7 µm
Standard Deviation 7.2
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Supplemental injections per group. Any difference in group number from participant flow reflects variation in specific outcome measure follow up data availability due to image quality and variable follow up availability.
Average number of Injections
Outcome measures
| Measure |
Group A: Intravitreal Dexamethasone Implant
n=9 Participants
Subjects in this arm will be given intravitreal Dexamethasone implant injection at month 0. PRN intravitreal Dexamethasone implant injections will be given for persistent edema, if it has been 10 weeks or more since last implant injection. If it has been less than 10 weeks since last implant injection, subjects will receive PRN intravitreal Aflibercept for persistent edema.
Dexamethasone implant: A sustained-release drug delivery system containing 0.7 mg of Dexamethasone. Implant is administered by intravitreal injection.
Aflibercept: A single dose, 2mg, drug administered by intravitreal injection.
|
Group B: Intravitreal Aflibercept
n=10 Participants
Subjects in this arm will be given Intravitreal aflibercept at month 0. PRN intravitreal Aflibercept will be given at months 1-6 for persistent edema.
Aflibercept: A single dose, 2mg, drug administered by intravitreal injection.
|
Group A Run in Period
Patients received an initial aflibercept injection as outlined in the methods. This group is the patients who were subsequently randomized into Group A for the treatment arms of the study. This includes AEs for only the run in period (of one injection of aflibercept)
|
Group B Run in Period
Patients received an initial aflibercept injection as outlined in the methods. This group is the patients who were subsequently randomized into Group B for the treatment arms of the study. This includes AEs for only the run in period (of one injection of aflibercept)
|
|---|---|---|---|---|
|
Number of Injections
|
3.5 number of injections (mean)
Standard Deviation 1.8
|
4.4 number of injections (mean)
Standard Deviation 2.3
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Any difference in group number from participant flow reflects variation in specific outcome measure follow up data availability due to image quality and variable follow up availability.
Outcome measures
| Measure |
Group A: Intravitreal Dexamethasone Implant
n=9 Participants
Subjects in this arm will be given intravitreal Dexamethasone implant injection at month 0. PRN intravitreal Dexamethasone implant injections will be given for persistent edema, if it has been 10 weeks or more since last implant injection. If it has been less than 10 weeks since last implant injection, subjects will receive PRN intravitreal Aflibercept for persistent edema.
Dexamethasone implant: A sustained-release drug delivery system containing 0.7 mg of Dexamethasone. Implant is administered by intravitreal injection.
Aflibercept: A single dose, 2mg, drug administered by intravitreal injection.
|
Group B: Intravitreal Aflibercept
n=10 Participants
Subjects in this arm will be given Intravitreal aflibercept at month 0. PRN intravitreal Aflibercept will be given at months 1-6 for persistent edema.
Aflibercept: A single dose, 2mg, drug administered by intravitreal injection.
|
Group A Run in Period
Patients received an initial aflibercept injection as outlined in the methods. This group is the patients who were subsequently randomized into Group A for the treatment arms of the study. This includes AEs for only the run in period (of one injection of aflibercept)
|
Group B Run in Period
Patients received an initial aflibercept injection as outlined in the methods. This group is the patients who were subsequently randomized into Group B for the treatment arms of the study. This includes AEs for only the run in period (of one injection of aflibercept)
|
|---|---|---|---|---|
|
Change in BCVA
|
-2.1 Letters ETDRS change over 6 months
Standard Deviation 4.8
|
7.2 Letters ETDRS change over 6 months
Standard Deviation 12.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Any difference in group number from participant flow reflects variation in specific outcome measure follow up data availability due to image quality and variable follow up availability.
Leakage index refers to the percentage of leakage measured across the region of interest which are both evaluated using an imaging software for analysis. Greater leakage represents increased disease activity. The leakage index goes from 0-100 at any timepoint, though the change parameter shown below can be negative.
Outcome measures
| Measure |
Group A: Intravitreal Dexamethasone Implant
n=9 Participants
Subjects in this arm will be given intravitreal Dexamethasone implant injection at month 0. PRN intravitreal Dexamethasone implant injections will be given for persistent edema, if it has been 10 weeks or more since last implant injection. If it has been less than 10 weeks since last implant injection, subjects will receive PRN intravitreal Aflibercept for persistent edema.
Dexamethasone implant: A sustained-release drug delivery system containing 0.7 mg of Dexamethasone. Implant is administered by intravitreal injection.
Aflibercept: A single dose, 2mg, drug administered by intravitreal injection.
|
Group B: Intravitreal Aflibercept
n=7 Participants
Subjects in this arm will be given Intravitreal aflibercept at month 0. PRN intravitreal Aflibercept will be given at months 1-6 for persistent edema.
Aflibercept: A single dose, 2mg, drug administered by intravitreal injection.
|
Group A Run in Period
Patients received an initial aflibercept injection as outlined in the methods. This group is the patients who were subsequently randomized into Group A for the treatment arms of the study. This includes AEs for only the run in period (of one injection of aflibercept)
|
Group B Run in Period
Patients received an initial aflibercept injection as outlined in the methods. This group is the patients who were subsequently randomized into Group B for the treatment arms of the study. This includes AEs for only the run in period (of one injection of aflibercept)
|
|---|---|---|---|---|
|
Change in Leakage Index
|
-1.59 percentage of total leakage
Standard Deviation 3.3
|
-4.7 percentage of total leakage
Standard Deviation 3.9
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Any difference in group number from participant flow reflects variation in specific outcome measure follow up data availability due to image quality and variable follow up availability.
Ischemic index represents the percentage of ischemia of the region of interest in fundus fluorescein angiography images. The range is 0-100 at each timepoint assessed. All things being equal greater ischemia corresponds to more severe disease. Given this parameter is a change between time points for this index, the number can be negative.
Outcome measures
| Measure |
Group A: Intravitreal Dexamethasone Implant
n=6 Participants
Subjects in this arm will be given intravitreal Dexamethasone implant injection at month 0. PRN intravitreal Dexamethasone implant injections will be given for persistent edema, if it has been 10 weeks or more since last implant injection. If it has been less than 10 weeks since last implant injection, subjects will receive PRN intravitreal Aflibercept for persistent edema.
Dexamethasone implant: A sustained-release drug delivery system containing 0.7 mg of Dexamethasone. Implant is administered by intravitreal injection.
Aflibercept: A single dose, 2mg, drug administered by intravitreal injection.
|
Group B: Intravitreal Aflibercept
n=9 Participants
Subjects in this arm will be given Intravitreal aflibercept at month 0. PRN intravitreal Aflibercept will be given at months 1-6 for persistent edema.
Aflibercept: A single dose, 2mg, drug administered by intravitreal injection.
|
Group A Run in Period
Patients received an initial aflibercept injection as outlined in the methods. This group is the patients who were subsequently randomized into Group A for the treatment arms of the study. This includes AEs for only the run in period (of one injection of aflibercept)
|
Group B Run in Period
Patients received an initial aflibercept injection as outlined in the methods. This group is the patients who were subsequently randomized into Group B for the treatment arms of the study. This includes AEs for only the run in period (of one injection of aflibercept)
|
|---|---|---|---|---|
|
Change in Ischemic Index
|
2.9 percentage of parameter in group
Standard Deviation 5.00
|
-7.3 percentage of parameter in group
Standard Deviation 4.98
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Any difference in group number from participant flow reflects variation in specific outcome measure follow up data availability due to image quality and variable follow up availability.
Microaneurysms are counted on the fluorescin angiography images. It is a count so there is not a set range though the vast majority of patients tend to fall between 0 to 2000 microaneurysms. All things being equal greater count represents more severe disease.
Outcome measures
| Measure |
Group A: Intravitreal Dexamethasone Implant
n=6 Participants
Subjects in this arm will be given intravitreal Dexamethasone implant injection at month 0. PRN intravitreal Dexamethasone implant injections will be given for persistent edema, if it has been 10 weeks or more since last implant injection. If it has been less than 10 weeks since last implant injection, subjects will receive PRN intravitreal Aflibercept for persistent edema.
Dexamethasone implant: A sustained-release drug delivery system containing 0.7 mg of Dexamethasone. Implant is administered by intravitreal injection.
Aflibercept: A single dose, 2mg, drug administered by intravitreal injection.
|
Group B: Intravitreal Aflibercept
n=9 Participants
Subjects in this arm will be given Intravitreal aflibercept at month 0. PRN intravitreal Aflibercept will be given at months 1-6 for persistent edema.
Aflibercept: A single dose, 2mg, drug administered by intravitreal injection.
|
Group A Run in Period
Patients received an initial aflibercept injection as outlined in the methods. This group is the patients who were subsequently randomized into Group A for the treatment arms of the study. This includes AEs for only the run in period (of one injection of aflibercept)
|
Group B Run in Period
Patients received an initial aflibercept injection as outlined in the methods. This group is the patients who were subsequently randomized into Group B for the treatment arms of the study. This includes AEs for only the run in period (of one injection of aflibercept)
|
|---|---|---|---|---|
|
Change in Microaneurysm Counts
|
-46 Microaneurysms
Standard Deviation 102.00
|
-445 Microaneurysms
Standard Deviation 101.99
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Any difference in group number from participant flow reflects variation in specific outcome measure follow up data availability due to image quality and variable follow up availability.
Change in ellipsoid zone integrity as measured by EZ-RPE volume. Reduced volume indicates increased disruption to the ellipsoid zone across the macular cube scan. The range is subject to differences between timepoints.
Outcome measures
| Measure |
Group A: Intravitreal Dexamethasone Implant
n=9 Participants
Subjects in this arm will be given intravitreal Dexamethasone implant injection at month 0. PRN intravitreal Dexamethasone implant injections will be given for persistent edema, if it has been 10 weeks or more since last implant injection. If it has been less than 10 weeks since last implant injection, subjects will receive PRN intravitreal Aflibercept for persistent edema.
Dexamethasone implant: A sustained-release drug delivery system containing 0.7 mg of Dexamethasone. Implant is administered by intravitreal injection.
Aflibercept: A single dose, 2mg, drug administered by intravitreal injection.
|
Group B: Intravitreal Aflibercept
n=8 Participants
Subjects in this arm will be given Intravitreal aflibercept at month 0. PRN intravitreal Aflibercept will be given at months 1-6 for persistent edema.
Aflibercept: A single dose, 2mg, drug administered by intravitreal injection.
|
Group A Run in Period
Patients received an initial aflibercept injection as outlined in the methods. This group is the patients who were subsequently randomized into Group A for the treatment arms of the study. This includes AEs for only the run in period (of one injection of aflibercept)
|
Group B Run in Period
Patients received an initial aflibercept injection as outlined in the methods. This group is the patients who were subsequently randomized into Group B for the treatment arms of the study. This includes AEs for only the run in period (of one injection of aflibercept)
|
|---|---|---|---|---|
|
Change in Ellipsoid Zone Integrity
|
0.05 change in EZ volume per group (mm^3)
Standard Deviation .078
|
0.00 change in EZ volume per group (mm^3)
Standard Deviation .069
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Any difference in group number from participant flow reflects variation in specific outcome measure follow up data availability due to image quality and variable follow up availability.
This parameter is the total intraretinal fluid measured on the OCT imaging platform across the entire macular cube scan. It is a quantitative measure of macular edema and higher volume represents worse swelling.
Outcome measures
| Measure |
Group A: Intravitreal Dexamethasone Implant
n=9 Participants
Subjects in this arm will be given intravitreal Dexamethasone implant injection at month 0. PRN intravitreal Dexamethasone implant injections will be given for persistent edema, if it has been 10 weeks or more since last implant injection. If it has been less than 10 weeks since last implant injection, subjects will receive PRN intravitreal Aflibercept for persistent edema.
Dexamethasone implant: A sustained-release drug delivery system containing 0.7 mg of Dexamethasone. Implant is administered by intravitreal injection.
Aflibercept: A single dose, 2mg, drug administered by intravitreal injection.
|
Group B: Intravitreal Aflibercept
n=8 Participants
Subjects in this arm will be given Intravitreal aflibercept at month 0. PRN intravitreal Aflibercept will be given at months 1-6 for persistent edema.
Aflibercept: A single dose, 2mg, drug administered by intravitreal injection.
|
Group A Run in Period
Patients received an initial aflibercept injection as outlined in the methods. This group is the patients who were subsequently randomized into Group A for the treatment arms of the study. This includes AEs for only the run in period (of one injection of aflibercept)
|
Group B Run in Period
Patients received an initial aflibercept injection as outlined in the methods. This group is the patients who were subsequently randomized into Group B for the treatment arms of the study. This includes AEs for only the run in period (of one injection of aflibercept)
|
|---|---|---|---|---|
|
Change in Intraretinal Fluid Volume
|
-0.22 mm^3
Standard Deviation .346
|
-0.65 mm^3
Standard Deviation .956
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This group number reflects availability of follow up imaging of sufficient quality for comparison to the screening visit to assess DRSS accurately. Any difference in group number from participant flow reflects variation in specific outcome measure follow up data availability due to image quality and variable follow up availability.
Diabetic retinopathy severity scale (DRSS) was assessed at the screening visit and the month 6 visit using color fundus photography across both the intravitreal dexamethasone implant (Group A) and the intravitreal aflibercept group (Group B). DRSS assesses disease severity by extent of diabetic involvement in the eye from microaneurysms only (low severity) to vitreous hemorrhage and/or neovascularization of the disc (high severity). The scale using the ETDRS Steps range from 1 to 12. A higher score represents more severe diabetic disease burden. Thus a more negative change in DRSS value corresponds to a better therapeutic response.
Outcome measures
| Measure |
Group A: Intravitreal Dexamethasone Implant
n=8 Participants
Subjects in this arm will be given intravitreal Dexamethasone implant injection at month 0. PRN intravitreal Dexamethasone implant injections will be given for persistent edema, if it has been 10 weeks or more since last implant injection. If it has been less than 10 weeks since last implant injection, subjects will receive PRN intravitreal Aflibercept for persistent edema.
Dexamethasone implant: A sustained-release drug delivery system containing 0.7 mg of Dexamethasone. Implant is administered by intravitreal injection.
Aflibercept: A single dose, 2mg, drug administered by intravitreal injection.
|
Group B: Intravitreal Aflibercept
n=6 Participants
Subjects in this arm will be given Intravitreal aflibercept at month 0. PRN intravitreal Aflibercept will be given at months 1-6 for persistent edema.
Aflibercept: A single dose, 2mg, drug administered by intravitreal injection.
|
Group A Run in Period
Patients received an initial aflibercept injection as outlined in the methods. This group is the patients who were subsequently randomized into Group A for the treatment arms of the study. This includes AEs for only the run in period (of one injection of aflibercept)
|
Group B Run in Period
Patients received an initial aflibercept injection as outlined in the methods. This group is the patients who were subsequently randomized into Group B for the treatment arms of the study. This includes AEs for only the run in period (of one injection of aflibercept)
|
|---|---|---|---|---|
|
Change in DRSS
|
-0.25 units on a scale
Standard Deviation 0.7
|
-1.3 units on a scale
Standard Deviation 1.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Parameters analyzed for AEs included subconjunctival hemorrhage, vitreous hemorrhage, pain, infection, bleeding.
Number of adverse events.
Outcome measures
| Measure |
Group A: Intravitreal Dexamethasone Implant
n=10 Participants
Subjects in this arm will be given intravitreal Dexamethasone implant injection at month 0. PRN intravitreal Dexamethasone implant injections will be given for persistent edema, if it has been 10 weeks or more since last implant injection. If it has been less than 10 weeks since last implant injection, subjects will receive PRN intravitreal Aflibercept for persistent edema.
Dexamethasone implant: A sustained-release drug delivery system containing 0.7 mg of Dexamethasone. Implant is administered by intravitreal injection.
Aflibercept: A single dose, 2mg, drug administered by intravitreal injection.
|
Group B: Intravitreal Aflibercept
n=11 Participants
Subjects in this arm will be given Intravitreal aflibercept at month 0. PRN intravitreal Aflibercept will be given at months 1-6 for persistent edema.
Aflibercept: A single dose, 2mg, drug administered by intravitreal injection.
|
Group A Run in Period
n=10 Participants
Patients received an initial aflibercept injection as outlined in the methods. This group is the patients who were subsequently randomized into Group A for the treatment arms of the study. This includes AEs for only the run in period (of one injection of aflibercept)
|
Group B Run in Period
n=11 Participants
Patients received an initial aflibercept injection as outlined in the methods. This group is the patients who were subsequently randomized into Group B for the treatment arms of the study. This includes AEs for only the run in period (of one injection of aflibercept)
|
|---|---|---|---|---|
|
The Incidence and Severity of Ocular and Non-ocular Adverse Events and Serious Adverse Events
|
6 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Group A: Intravitreal Dexamethasone Implant
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Group B: Intravitreal Aflibercept
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group A Run in Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B Run in Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A: Intravitreal Dexamethasone Implant
n=10 participants at risk
Subjects in this arm will be given intravitreal Dexamethasone implant injection at month 0. PRN intravitreal Dexamethasone implant injections will be given for persistent edema, if it has been 10 weeks or more since last implant injection. If it has been less than 10 weeks since last implant injection, subjects will receive PRN intravitreal Aflibercept for persistent edema.
Dexamethasone implant: A sustained-release drug delivery system containing 0.7 mg of Dexamethasone. Implant is administered by intravitreal injection.
Aflibercept: A single dose, 2mg, drug administered by intravitreal injection. AEs reported here for Group A includes any AEs for a subject who was randomized to Group A for the entire study including the run-in period
|
Group B: Intravitreal Aflibercept
n=11 participants at risk
Group B: Intravitreal Aflibercept Subjects in this arm will be given Intravitreal aflibercept at month 0. PRN intravitreal Aflibercept will be given at months 1-6 for persistent edema.
Aflibercept: A single dose, 2mg, drug administered by intravitreal injection. AEs reported here for Group B includes any AEs for a subject who was randomized to Group B for the entire study including the run-in period
|
Group A Run in Period
n=10 participants at risk
Patients received an initial aflibercept injection as outlined in the methods. This group is the patients who were subsequently randomized into Group A for the treatment arms of the study. This includes AEs for only the run in period (of one injection of aflibercept)
|
Group B Run in Period
n=11 participants at risk
Patients received an initial aflibercept injection as outlined in the methods. This group is the patients who were subsequently randomized into Group B for the treatment arms of the study. This includes AEs for only the run in period (of one injection of aflibercept)
|
|---|---|---|---|---|
|
Vascular disorders
Hypertensive urgency
|
10.0%
1/10 • Number of events 1 • 6 months
An adverse event (AE) is any untoward medical occurrence in a patient administered a study drug which may or may not have a causal relationship with the study drug. An AE also includes any worsening of a pre-existing condition that is temporally associated with the use of the study drug. Patients are listed here based on their randomized group. All subjects were randomized and all AEs are listed for a subjects from the time of enrollment including the run-in period.
|
0.00%
0/11 • 6 months
An adverse event (AE) is any untoward medical occurrence in a patient administered a study drug which may or may not have a causal relationship with the study drug. An AE also includes any worsening of a pre-existing condition that is temporally associated with the use of the study drug. Patients are listed here based on their randomized group. All subjects were randomized and all AEs are listed for a subjects from the time of enrollment including the run-in period.
|
0.00%
0/10 • 6 months
An adverse event (AE) is any untoward medical occurrence in a patient administered a study drug which may or may not have a causal relationship with the study drug. An AE also includes any worsening of a pre-existing condition that is temporally associated with the use of the study drug. Patients are listed here based on their randomized group. All subjects were randomized and all AEs are listed for a subjects from the time of enrollment including the run-in period.
|
0.00%
0/11 • 6 months
An adverse event (AE) is any untoward medical occurrence in a patient administered a study drug which may or may not have a causal relationship with the study drug. An AE also includes any worsening of a pre-existing condition that is temporally associated with the use of the study drug. Patients are listed here based on their randomized group. All subjects were randomized and all AEs are listed for a subjects from the time of enrollment including the run-in period.
|
Other adverse events
| Measure |
Group A: Intravitreal Dexamethasone Implant
n=10 participants at risk
Subjects in this arm will be given intravitreal Dexamethasone implant injection at month 0. PRN intravitreal Dexamethasone implant injections will be given for persistent edema, if it has been 10 weeks or more since last implant injection. If it has been less than 10 weeks since last implant injection, subjects will receive PRN intravitreal Aflibercept for persistent edema.
Dexamethasone implant: A sustained-release drug delivery system containing 0.7 mg of Dexamethasone. Implant is administered by intravitreal injection.
Aflibercept: A single dose, 2mg, drug administered by intravitreal injection. AEs reported here for Group A includes any AEs for a subject who was randomized to Group A for the entire study including the run-in period
|
Group B: Intravitreal Aflibercept
n=11 participants at risk
Group B: Intravitreal Aflibercept Subjects in this arm will be given Intravitreal aflibercept at month 0. PRN intravitreal Aflibercept will be given at months 1-6 for persistent edema.
Aflibercept: A single dose, 2mg, drug administered by intravitreal injection. AEs reported here for Group B includes any AEs for a subject who was randomized to Group B for the entire study including the run-in period
|
Group A Run in Period
n=10 participants at risk
Patients received an initial aflibercept injection as outlined in the methods. This group is the patients who were subsequently randomized into Group A for the treatment arms of the study. This includes AEs for only the run in period (of one injection of aflibercept)
|
Group B Run in Period
n=11 participants at risk
Patients received an initial aflibercept injection as outlined in the methods. This group is the patients who were subsequently randomized into Group B for the treatment arms of the study. This includes AEs for only the run in period (of one injection of aflibercept)
|
|---|---|---|---|---|
|
Eye disorders
Ocular Nonserious AE
|
50.0%
5/10 • Number of events 5 • 6 months
An adverse event (AE) is any untoward medical occurrence in a patient administered a study drug which may or may not have a causal relationship with the study drug. An AE also includes any worsening of a pre-existing condition that is temporally associated with the use of the study drug. Patients are listed here based on their randomized group. All subjects were randomized and all AEs are listed for a subjects from the time of enrollment including the run-in period.
|
54.5%
6/11 • Number of events 6 • 6 months
An adverse event (AE) is any untoward medical occurrence in a patient administered a study drug which may or may not have a causal relationship with the study drug. An AE also includes any worsening of a pre-existing condition that is temporally associated with the use of the study drug. Patients are listed here based on their randomized group. All subjects were randomized and all AEs are listed for a subjects from the time of enrollment including the run-in period.
|
0.00%
0/10 • 6 months
An adverse event (AE) is any untoward medical occurrence in a patient administered a study drug which may or may not have a causal relationship with the study drug. An AE also includes any worsening of a pre-existing condition that is temporally associated with the use of the study drug. Patients are listed here based on their randomized group. All subjects were randomized and all AEs are listed for a subjects from the time of enrollment including the run-in period.
|
0.00%
0/11 • 6 months
An adverse event (AE) is any untoward medical occurrence in a patient administered a study drug which may or may not have a causal relationship with the study drug. An AE also includes any worsening of a pre-existing condition that is temporally associated with the use of the study drug. Patients are listed here based on their randomized group. All subjects were randomized and all AEs are listed for a subjects from the time of enrollment including the run-in period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place