Trial Outcomes & Findings for Study of the Effectiveness of Ozurdex for the Control of Uveitis (NCT NCT02049476)
NCT ID: NCT02049476
Last Updated: 2019-07-05
Results Overview
Absence of intraocular inflammation (e.g. less than trace anterior chamber (AC) cells; no vitreous haze; inactive chorioretinal lesions) is used to assess control of intraocular inflammation following treatment.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
at 6-month visit
Results posted on
2019-07-05
Participant Flow
Unit of analysis: Eyes
Participant milestones
| Measure |
Dexamethasone Pellet
This is a proof of concept study; therefore all enrolled patients will receive the intervention according to its FDA-approved indication.
Dexamethasone pellet: Dexamethasone pellet placement occurs within 14 days of baseline examination; for patients with bilaterally active uveitis, placement of a dexamethasone pellet in the second eye should occur within 14 days of the first implantation or within 30 day of the baseline examination.
Repeated placement is permitted every 3 months based on the best clinical judgment of the doctor and the study protocol.
|
|---|---|
|
Overall Study
STARTED
|
20 28
|
|
Overall Study
COMPLETED
|
20 28
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Effectiveness of Ozurdex for the Control of Uveitis
Baseline characteristics by cohort
| Measure |
Dexamethasone Pellet
n=20 Participants
This is a proof of concept study; therefore all enrolled patients will receive the intervention according to its FDA-approved indication.
Dexamethasone pellet: Dexamethasone pellet placement occurs within 14 days of baseline examination; for patients with bilaterally active uveitis, placement of a dexamethasone pellet in the second eye should occur within 14 days of the first implantation or within 30 day of the baseline examination.
Repeated placement is permitted every 3 months based on the best clinical judgment of the doctor and the study protocol.
|
|---|---|
|
Age, Continuous
|
52 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
|
Type of uveitis
Anterior and Intermediate
|
7 Participants
n=5 Participants
|
|
Type of uveitis
Intermediate
|
4 Participants
n=5 Participants
|
|
Type of uveitis
Posterior
|
9 Participants
n=5 Participants
|
|
Bilaterality of uveitis
Unilateral
|
0 Participants
n=5 Participants
|
|
Bilaterality of uveitis
Bilateral
|
20 Participants
n=5 Participants
|
|
Activity of uveitis
Active vitreous cell
|
8 Participants
n=5 Participants
|
|
Activity of uveitis
Active vitreous haze
|
4 Participants
n=5 Participants
|
|
Activity of uveitis
Active chorioretinal lesions
|
2 Participants
n=5 Participants
|
|
Activity of uveitis
Active retinal vasculitis/leakage
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 6-month visitAbsence of intraocular inflammation (e.g. less than trace anterior chamber (AC) cells; no vitreous haze; inactive chorioretinal lesions) is used to assess control of intraocular inflammation following treatment.
Outcome measures
| Measure |
Dexamethasone Pellet
n=20 Participants
This is a proof of concept study; therefore all enrolled patients will receive the intervention according to its FDA-approved indication.
Dexamethasone pellet: Dexamethasone pellet placement occurs within 14 days of baseline examination; for patients with bilaterally active uveitis, placement of a dexamethasone pellet in the second eye should occur within 14 days of the first implantation or within 30 day of the baseline examination.
Repeated placement is permitted every 3 months based on the best clinical judgment of the doctor and the study protocol.
|
|---|---|
|
Number of Participants With Absence of Intraocular Inflammation at 6 Months
|
12 Participants
|
SECONDARY outcome
Timeframe: 12-month clinical visitAbsence of intraocular inflammation (e.g. less than trace anterior chamber (AC) cells; no vitreous haze; inactive chorioretinal lesions) is used to assess control of intraocular inflammation following treatment.
Outcome measures
| Measure |
Dexamethasone Pellet
n=20 Participants
This is a proof of concept study; therefore all enrolled patients will receive the intervention according to its FDA-approved indication.
Dexamethasone pellet: Dexamethasone pellet placement occurs within 14 days of baseline examination; for patients with bilaterally active uveitis, placement of a dexamethasone pellet in the second eye should occur within 14 days of the first implantation or within 30 day of the baseline examination.
Repeated placement is permitted every 3 months based on the best clinical judgment of the doctor and the study protocol.
|
|---|---|
|
Number of Participants With Absence of Intraocular Inflammation at 12 Months
|
13 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 1 month, 3 months, 6 months, and 12 months visitMean IOP (mmHg) was calculated at each visit
Outcome measures
| Measure |
Dexamethasone Pellet
n=28 eyes
This is a proof of concept study; therefore all enrolled patients will receive the intervention according to its FDA-approved indication.
Dexamethasone pellet: Dexamethasone pellet placement occurs within 14 days of baseline examination; for patients with bilaterally active uveitis, placement of a dexamethasone pellet in the second eye should occur within 14 days of the first implantation or within 30 day of the baseline examination.
Repeated placement is permitted every 3 months based on the best clinical judgment of the doctor and the study protocol.
|
|---|---|
|
Mean Intraocular Pressure (IOP)
Baseline IOP
|
13.2 millimeters of Mercury (mm Hg)
Standard Deviation 0.8
|
|
Mean Intraocular Pressure (IOP)
Month 1 Visit
|
18.2 millimeters of Mercury (mm Hg)
Standard Deviation 2.0
|
|
Mean Intraocular Pressure (IOP)
Month 3 Visit
|
14.6 millimeters of Mercury (mm Hg)
Standard Deviation 1.3
|
|
Mean Intraocular Pressure (IOP)
Month 6 Visit
|
14.1 millimeters of Mercury (mm Hg)
Standard Deviation 1.3
|
|
Mean Intraocular Pressure (IOP)
Month 12 Visit
|
13.5 millimeters of Mercury (mm Hg)
Standard Deviation 1.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 1 month, 3 months, 6 months, and 12 months visitNumber of eyes that had progression of cataract defined as any interval increase in nuclear, cortical or posterior sub capsular cataract from a previous visit that resulted in cataract surgery.
Outcome measures
| Measure |
Dexamethasone Pellet
n=28 eyes
This is a proof of concept study; therefore all enrolled patients will receive the intervention according to its FDA-approved indication.
Dexamethasone pellet: Dexamethasone pellet placement occurs within 14 days of baseline examination; for patients with bilaterally active uveitis, placement of a dexamethasone pellet in the second eye should occur within 14 days of the first implantation or within 30 day of the baseline examination.
Repeated placement is permitted every 3 months based on the best clinical judgment of the doctor and the study protocol.
|
|---|---|
|
Number of Eyes With a Need for Cataract Surgery
Baseline visit
|
0 eyes
|
|
Number of Eyes With a Need for Cataract Surgery
Month 1 visit
|
0 eyes
|
|
Number of Eyes With a Need for Cataract Surgery
Month 3 visit
|
0 eyes
|
|
Number of Eyes With a Need for Cataract Surgery
Month 6 visit
|
1 eyes
|
|
Number of Eyes With a Need for Cataract Surgery
Month12 visit
|
3 eyes
|
Adverse Events
Dexamethasone Pellet
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dexamethasone Pellet
n=20 participants at risk
This is a proof of concept study; therefore all enrolled patients will receive the intervention according to its FDA-approved indication.
Dexamethasone pellet: Dexamethasone pellet placement occurs within 14 days of baseline examination; for patients with bilaterally active uveitis, placement of a dexamethasone pellet in the second eye should occur within 14 days of the first implantation or within 30 day of the baseline examination.
Repeated placement is permitted every 3 months based on the best clinical judgment of the doctor and the study protocol.
|
|---|---|
|
Eye disorders
Cataract progression
|
20.0%
4/20 • Number of events 6 • All 20 patients were followed for 12 months after their first Ozurdex injection to look for adverse events
|
|
Eye disorders
Ocular hypertension
|
35.0%
7/20 • Number of events 9 • All 20 patients were followed for 12 months after their first Ozurdex injection to look for adverse events
|
|
Eye disorders
Cataract surgery
|
10.0%
2/20 • Number of events 4 • All 20 patients were followed for 12 months after their first Ozurdex injection to look for adverse events
|
Additional Information
Jennifer E. Thorne, MD, PhD; Professor of Ophthalmology & Epidemiology,Director of Ocular Immunology
Wilmer Eye Institute, Johns Hopkins University School of Medicine
Phone: 410-955-2966
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place