Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 615 for:    PLG

Microplasmin Intravitreal Administration in Participants With Uveitic Macular Edema (MIME)

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: NCT01194674
Recruitment Status : Terminated (Lack of enrollment.)
First Posted : September 3, 2010
Results First Posted : August 14, 2012
Last Update Posted : July 31, 2018
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Nida Sen, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Uveitis
Intervention Drug: Microplasmin
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Microplasmin
Hide Arm/Group Description Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
Period Title: Overall Study
Started 2
Completed 2
Not Completed 0
Arm/Group Title Microplasmin
Hide Arm/Group Description Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 2 participants
40.50
(28 to 53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
1
  50.0%
Male
1
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Number of Adverse Events
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Microplasmin
Hide Arm/Group Description:
Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: Adverse Events
4
2.Primary Outcome
Title Number of Severe Adverse Events
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Microplasmin
Hide Arm/Group Description:
Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: Adverse Events
0
3.Primary Outcome
Title Number of Ocular Adverse Events
Hide Description The number of eye-related adverse events was calculated.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Microplasmin
Hide Arm/Group Description:
Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: Adverse Events
1
4.Primary Outcome
Title Number of Non-ocular Adverse Events
Hide Description The number of adverse events that were not eye-related was calculated.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Microplasmin
Hide Arm/Group Description:
Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: Adverse Events
3
5.Secondary Outcome
Title Change in Central Macular Thickness, as Measured by Optical Coherence Tomography (OCT), at 4 Weeks vs. Baseline
Hide Description Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue. This protocol terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This protocol terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.
Arm/Group Title Microplasmin
Hide Arm/Group Description:
Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Number of Participants Achieving Macular or Complete Posterior Vitreous Detachment (PVT) at 4 Weeks
Hide Description This study terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This protocol terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.
Arm/Group Title Microplasmin
Hide Arm/Group Description:
Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Change in ETDRS Best-corrected Visual Acuity (BCVA) at 4 Weeks vs. Baseline
Hide Description Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. This study terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This protocol terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.
Arm/Group Title Microplasmin
Hide Arm/Group Description:
Microplasmin: Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Change in ETDRS Best-corrected Visual Acuity (BCVA) at 12 Weeks vs. Baseline
Hide Description Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. This study terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.
Time Frame Baseline and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This protocol terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.
Arm/Group Title Microplasmin
Hide Arm/Group Description:
Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Change in Retino-vascular Leakage, as Seen on Fluorescein Angiography (FA), at 4 Weeks vs. Baseline
Hide Description Retino-vascular leakage was calculated after manually outlining the inner and outer borders of the subretinal fluid packet in the optical coherence tomography (OCT) images using the "Edit Segmentation" function of the Cirrus HD-OCT software. For cases in which a pigment epithelial detachment was present, the volume of the pigment epithelial detachment was included in the calculation of leakage volume. This study terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This protocol terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.
Arm/Group Title Microplasmin
Hide Arm/Group Description:
Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Microplasmin
Hide Arm/Group Description Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
All-Cause Mortality
Microplasmin
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Microplasmin
Affected / at Risk (%) # Events
Total   0/2 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Microplasmin
Affected / at Risk (%) # Events
Total   1/2 (50.00%)    
Infections and infestations   
Conjunctivitis infective  1  1/2 (50.00%)  1
Investigations   
Blood glucose increased  1  1/2 (50.00%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/2 (50.00%)  1
Skin and subcutaneous tissue disorders   
Rash  1  1/2 (50.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
The study was terminated early due to lack of enrollment.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: H. Nida Sen, Principal Investigator, National Eye Institute
Organization: National Institutes of Health
Phone: 301-402-3254
Responsible Party: Nida Sen, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01194674     History of Changes
Other Study ID Numbers: 100186
10-EI-0186 ( Other Identifier: CNS IRB )
First Submitted: September 2, 2010
First Posted: September 3, 2010
Results First Submitted: July 10, 2012
Results First Posted: August 14, 2012
Last Update Posted: July 31, 2018