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Trial record 2 of 7 for:    15078674 [PUBMED-IDS]

A Pilot Study for the Evaluation of Minocycline as a Microglia Inhibitor in the Treatment of Diabetic Macular Edema

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ClinicalTrials.gov Identifier: NCT01120899
Recruitment Status : Completed
First Posted : May 11, 2010
Results First Posted : September 6, 2012
Last Update Posted : October 17, 2014
Sponsor:
Collaborator:
The EMMES Corporation
Information provided by (Responsible Party):
Catherine Cukras, 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 Diabetic Macular Edema
Intervention Drug: Minocycline
Enrollment 6

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Minocycline
Hide Arm/Group Description Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
Period Title: Overall Study
Started 6
Month 6 5
Month 12 3
Month 18 3
Completed 3
Not Completed 3
Reason Not Completed
Withdrawal by Subject             3
Arm/Group Title Minocycline
Hide Arm/Group Description Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
  66.7%
>=65 years
2
  33.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
63.8  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
2
  33.3%
Male
4
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Number of Study Eyes Demonstrating an Increase or Decrease in Best-corrected Visual Acuity (BCVA) of 15 or More Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at 6 Months Compared to 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.

The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the "choice of study eye in cases of bilateral disease" selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the "fellow eye."

Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline
Hide Arm/Group Description:
Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
Overall Number of Participants Analyzed 5
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
5
Measure Type: Number
Unit of Measure: Eyes
1
2.Secondary Outcome
Title Change in BCVA in the Study Eye at 6 Months Compared to 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.

The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the "choice of study eye in cases of bilateral disease" selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the "fellow eye."

Time Frame Baseline and 6 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline
Hide Arm/Group Description:
Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
Overall Number of Participants Analyzed 5
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
5
Mean (Standard Deviation)
Unit of Measure: ETDRS Letters
5.8  (5.4)
3.Secondary Outcome
Title Change in BCVA in the Study Eye at 12 Months Compared to 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.

The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the "choice of study eye in cases of bilateral disease" selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the "fellow eye."

Time Frame Baseline and 12 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline
Hide Arm/Group Description:
Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
Overall Number of Participants Analyzed 3
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
3
Mean (Standard Deviation)
Unit of Measure: ETDRS Letters
8.0  (8.9)
4.Secondary Outcome
Title Change in BCVA in the Study Eye at 18 Months Compared to 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.
Time Frame Baseline and 18 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline
Hide Arm/Group Description:
Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
Overall Number of Participants Analyzed 3
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
3
Mean (Standard Deviation)
Unit of Measure: ETDRS letters
9.0  (4.0)
5.Secondary Outcome
Title Change in BCVA in the Study Eye at 24 Months Compared to 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.
Time Frame Baseline and 24 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline
Hide Arm/Group Description:
Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
Overall Number of Participants Analyzed 3
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
3
Mean (Standard Deviation)
Unit of Measure: ETDRS letters
9.3  (6.8)
6.Secondary Outcome
Title Percentage Change in Retinal Thickness in the Study Eye at 6 Months Compared to 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.

The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the "choice of study eye in cases of bilateral disease" selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the "fellow eye."

Time Frame Baseline and 6 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline
Hide Arm/Group Description:
Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
Overall Number of Participants Analyzed 5
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
5
Mean (Standard Deviation)
Unit of Measure: percentage change
-8.1  (14.6)
7.Secondary Outcome
Title Percentage Change in Retinal Thickness in the Study Eye at 12 Months Compared to 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.
Time Frame Baseline and 12 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline
Hide Arm/Group Description:
Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
Overall Number of Participants Analyzed 3
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
3
Mean (Standard Deviation)
Unit of Measure: percentage change in retinal thickness
-12.35  (1.21)
8.Secondary Outcome
Title Percentage Change in Retinal Thickness in the Study Eye at 18 Months Compared to 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.
Time Frame Baseline and 18 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline
Hide Arm/Group Description:
Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
Overall Number of Participants Analyzed 3
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
3
Mean (Standard Deviation)
Unit of Measure: percentage change in retinal thickness
-20.09  (10.65)
9.Secondary Outcome
Title Percentage Change in Retinal Thickness in the Study Eye at 24 Months Compared to 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.
Time Frame Baseline and 24 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline
Hide Arm/Group Description:
Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
Overall Number of Participants Analyzed 3
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
3
Mean (Standard Deviation)
Unit of Measure: percentage change in retinal thickness
-20.83  (4.62)
10.Secondary Outcome
Title Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 6 Months Compared to Baseline
Hide Description

Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).

The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the "choice of study eye in cases of bilateral disease" selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the "fellow eye."

Time Frame 6 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline
Hide Arm/Group Description:
Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
Overall Number of Participants Analyzed 5
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
5
Measure Type: Number
Unit of Measure: Eyes
5
11.Secondary Outcome
Title Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 12 Months Compared to Baseline
Hide Description

Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).

The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the "choice of study eye in cases of bilateral disease" selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the "fellow eye."

Time Frame 12 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline
Hide Arm/Group Description:
Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
Overall Number of Participants Analyzed 3
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
3
Measure Type: Number
Unit of Measure: Eyes
3
12.Secondary Outcome
Title Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 18 Months Compared to Baseline
Hide Description

Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).

The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the "choice of study eye in cases of bilateral disease" selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the "fellow eye."

Time Frame 18 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline
Hide Arm/Group Description:
Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
Overall Number of Participants Analyzed 3
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
3
Measure Type: Number
Unit of Measure: Eyes
3
13.Secondary Outcome
Title Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 24 Months Compared to Baseline
Hide Description

Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).

The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the "choice of study eye in cases of bilateral disease" selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the "fellow eye."

Time Frame 24 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline
Hide Arm/Group Description:
Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
Overall Number of Participants Analyzed 3
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
3
Measure Type: Number
Unit of Measure: Eyes
3
14.Secondary Outcome
Title Number of Fellow Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 6 Months Compared to Baseline
Hide Description

Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).

The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the "choice of study eye in cases of bilateral disease" selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the "fellow eye."

Time Frame 6 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline
Hide Arm/Group Description:
Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
Overall Number of Participants Analyzed 5
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
5
Measure Type: Number
Unit of Measure: Eyes
4
15.Secondary Outcome
Title Number of Fellow Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 12 Months Compared to Baseline
Hide Description

Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).

The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the "choice of study eye in cases of bilateral disease" selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the "fellow eye."

Time Frame 12 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline
Hide Arm/Group Description:
Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
Overall Number of Participants Analyzed 3
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
3
Measure Type: Number
Unit of Measure: Eyes
1
16.Secondary Outcome
Title Number of Fellow Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 18 Months Compared to Baseline
Hide Description

Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).

The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the "choice of study eye in cases of bilateral disease" selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the "fellow eye."

Time Frame 18 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline
Hide Arm/Group Description:
Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
Overall Number of Participants Analyzed 3
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
3
Measure Type: Number
Unit of Measure: Eyes
2
17.Secondary Outcome
Title Number of Fellow Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 24 Months Compared to Baseline
Hide Description

Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).

The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the "choice of study eye in cases of bilateral disease" selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the "fellow eye."

Time Frame 24 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline
Hide Arm/Group Description:
Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
Overall Number of Participants Analyzed 3
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
3
Measure Type: Number
Unit of Measure: Eyes
1
Time Frame 18 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Minocycline
Hide Arm/Group Description Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
All-Cause Mortality
Minocycline
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Minocycline
Affected / at Risk (%) # Events
Total   1/6 (16.67%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Laryngeal cancer  1  1/6 (16.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Minocycline
Affected / at Risk (%) # Events
Total   6/6 (100.00%)    
Cardiac disorders   
Palpitations  1  1/6 (16.67%)  1
Eye disorders   
Blepharitis  1  1/6 (16.67%)  1
Meibomianitis  1  1/6 (16.67%)  1
Gastrointestinal disorders   
Abdominal pain upper  1  1/6 (16.67%)  1
Diarrhoea  1  2/6 (33.33%)  5
Abdominal discomfort  1  1/6 (16.67%)  1
General disorders   
Fatigue  1  1/6 (16.67%)  1
Oedema peripheral  1  1/6 (16.67%)  1
Infections and infestations   
Gastroenteritis viral  1  1/6 (16.67%)  1
Nasopharyngitis  1  1/6 (16.67%)  1
Viral infection  1  1/6 (16.67%)  1
Tinea pedis  2  1/6 (16.67%)  1
Investigations   
Blood albumin decreased  1  1/6 (16.67%)  1
Blood glucose increased  1  2/6 (33.33%)  2
Blood magnesium decreased  1  1/6 (16.67%)  1
Blood thyroid stimulating hormone abnormal  1  1/6 (16.67%)  1
Glycosylated haemoglobin increased  1  1/6 (16.67%)  1
Haemoglobin decreased  1  2/6 (33.33%)  2
White blood cell count increased  1  1/6 (16.67%)  1
Blood pressure increased  1  1/6 (16.67%)  1
Metabolism and nutrition disorders   
Hypercholesterolaemia  1  1/6 (16.67%)  1
Musculoskeletal and connective tissue disorders   
Muscle spasms  1  1/6 (16.67%)  1
Musculoskeletal pain  1  1/6 (16.67%)  1
Nervous system disorders   
Dizziness  1  1/6 (16.67%)  1
Dysgeusia  1  1/6 (16.67%)  1
Headache  1  1/6 (16.67%)  1
Renal and urinary disorders   
Nephrolithiasis  1  1/6 (16.67%)  1
Reproductive system and breast disorders   
Vulvovaginal pruritus  1  1/6 (16.67%)  2
Respiratory, thoracic and mediastinal disorders   
Oropharyngeal pain  1  1/6 (16.67%)  1
Skin and subcutaneous tissue disorders   
Rash  1  1/6 (16.67%)  1
Skin ulcer  1  1/6 (16.67%)  1
Pruritis  3  1/6 (16.67%)  2
Skin hyperpigmentation  4  2/6 (33.33%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
2
Term from vocabulary, MedDRA (15.1)
3
Term from vocabulary, MedDRA (16.0)
4
Term from vocabulary, MedDRA (15.0-15.1)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Catherine Cukras, MD, PhD, Principal Investigator, NEI
Organization: National Institutes of Health
Phone: 301-435-5061
Responsible Party: Catherine Cukras, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01120899     History of Changes
Other Study ID Numbers: 100098
10-EI-0098 ( Other Identifier: CNS IRB )
First Submitted: May 8, 2010
First Posted: May 11, 2010
Results First Submitted: August 2, 2012
Results First Posted: September 6, 2012
Last Update Posted: October 17, 2014