Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 4 for:    "Choroiditis" | "BB 1101"

Study of the Effectiveness of Ozurdex for the Control of Uveitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02049476
Recruitment Status : Completed
First Posted : January 30, 2014
Results First Posted : July 3, 2019
Last Update Posted : July 3, 2019
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Uveitis, Intermediate
Uveitis, Posterior
Intervention Drug: Dexamethasone pellet
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dexamethasone Pellet
Hide Arm/Group Description

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.

Period Title: Overall Study
Number of participants Number of units (Eyes)
Started 20 [1] 28
Completed 20 [2] 28
Not Completed 0 0
[1]
First patient enrolled on 1/31/2014
[2]
20th patient completed the study
Arm/Group Title Dexamethasone Pellet
Hide Arm/Group Description

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 Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants
52
(27 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
17
  85.0%
Male
3
  15.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
8
  40.0%
White
12
  60.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
 100.0%
Type of uveitis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Anterior and Intermediate
7
  35.0%
Intermediate
4
  20.0%
Posterior
9
  45.0%
[1]
Measure Description: Type of uveitis is determined by the primary anatomic location of the inflammation.
Bilaterality of uveitis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Unilateral
0
   0.0%
Bilateral
20
 100.0%
[1]
Measure Description: Defined as either unilateral (one eye) or bilateral (both eye) with active uveitis.
Activity of uveitis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Active vitreous cell
8
  40.0%
Active vitreous haze
4
  20.0%
Active chorioretinal lesions
2
  10.0%
Active retinal vasculitis/leakage
6
  30.0%
[1]
Measure Description: Active disease as defined by treating ophthalmologist. Typically this is active vitreous cell or vitreous haze in the case of intermediate uveitis and active chorioretinal lesions or retinal vasculitis/leakage in posterior uveitis.
1.Primary Outcome
Title Number of Participants With Absence of Intraocular Inflammation at 6 Months
Hide Description 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.
Time Frame at 6-month visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Pellet
Hide Arm/Group Description:

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 Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
12
  60.0%
2.Secondary Outcome
Title Number of Participants With Absence of Intraocular Inflammation at 12 Months
Hide Description 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.
Time Frame 12-month clinical visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Pellet
Hide Arm/Group Description:

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 Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
13
  65.0%
3.Other Pre-specified Outcome
Title Mean Intraocular Pressure (IOP)
Hide Description Mean IOP (mmHg) was calculated at each visit
Time Frame Baseline, 1 month, 3 months, 6 months, and 12 months visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Pellet
Hide Arm/Group Description:

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 Number of Participants Analyzed 20
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
28
Mean (Standard Deviation)
Unit of Measure: millimeters of Mercury (mm Hg)
Baseline IOP 13.2  (0.8)
Month 1 Visit 18.2  (2.0)
Month 3 Visit 14.6  (1.3)
Month 6 Visit 14.1  (1.3)
Month 12 Visit 13.5  (1.1)
4.Other Pre-specified Outcome
Title Number of Eyes With a Need for Cataract Surgery
Hide Description Number 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.
Time Frame Baseline, 1 month, 3 months, 6 months, and 12 months visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Pellet
Hide Arm/Group Description:

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 Number of Participants Analyzed 20
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
28
Count of Units
Unit of Measure: eyes
Baseline visit
0
   0.0%
Month 1 visit
0
   0.0%
Month 3 visit
0
   0.0%
Month 6 visit
1
   3.6%
Month12 visit
3
  10.7%
Time Frame All 20 patients were followed for 12 months after their first Ozurdex injection to look for adverse events
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dexamethasone Pellet
Hide Arm/Group Description

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.

All-Cause Mortality
Dexamethasone Pellet
Affected / at Risk (%)
Total   0/20 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Dexamethasone Pellet
Affected / at Risk (%) # Events
Total   0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dexamethasone Pellet
Affected / at Risk (%) # Events
Total   13/20 (65.00%)    
Eye disorders   
Cataract progression   4/20 (20.00%)  6
Ocular hypertension  [1]  7/20 (35.00%)  9
Cataract surgery  [2]  2/20 (10.00%)  4
Indicates events were collected by systematic assessment
[1]
Intraocular pressure (IOP) of 25 mmHg or higher on any visit
[2]
progression of a cataract that required surgery
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jennifer E. Thorne, MD, PhD; Professor of Ophthalmology & Epidemiology,Director of Ocular Immunology
Organization: Wilmer Eye Institute, Johns Hopkins University School of Medicine
Phone: 410-955-2966
EMail: jthorne@jhmi.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02049476     History of Changes
Other Study ID Numbers: NA_00088146
First Submitted: January 27, 2014
First Posted: January 30, 2014
Results First Submitted: June 10, 2019
Results First Posted: July 3, 2019
Last Update Posted: July 3, 2019