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Treatment of Non-infectious Intermediate and Posterior Uveitis Associated Macular Edema With Intravitreal Methotrexate (MEXX)

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: NCT01314417
Recruitment Status : Terminated (This study was terminated due to lack of recruitment.)
First Posted : March 14, 2011
Results First Posted : September 26, 2013
Last Update Posted : March 27, 2019
Sponsor:
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 Non-infectious Intermediate and Posterior Uveitis
Intervention Drug: Methotrexate
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Methotrexate
Hide Arm/Group Description Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
Period Title: Overall Study
Started 2
Completed 2
Not Completed 0
Arm/Group Title Methotrexate
Hide Arm/Group Description Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
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 (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants
55.0  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
2
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Number of Participants Who Meet the Definition of Treatment Success Within 12 Weeks From Baseline.
Hide Description

Treatment success is defined as achieving at least a 1-step decrease in the LogScore scale for central macular thickness.

A decrease of at least 1-step on the logOCT scale, where Change in logOCT=log(follow-up thickness/200) - log(baseline thickness/200) is considered clinically significant. A 1-step decrease is equivalent to at least a 20% improvement of central macular thickness and represents greater than twice the variability of retinal thickness measurements (approximately 25-30 µ).

Examples of OCT measurements with their corresponding LogScore, where LogScore=10xlogOCT are as follows:

LogScore 0 = OCT 200 µm, LogScore 1 = OCT 250 µm, LogScore 2 = OCT 320 µm, LogScore 3 = OCT 400 µm, LogScore 4 = OCT 500 µm, LogScore 5 = OCT 640 µm, LogScore 6 = OCT 800 µm, LogScore 7 = OCT 1000 µm

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methotrexate
Hide Arm/Group Description:
Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: Participants
2
2.Secondary Outcome
Title Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 4 Weeks Compared to Baseline
Hide Description

Excess retinal thickening 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.

Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methotrexate
Hide Arm/Group Description:
Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
Overall Number of Participants Analyzed 2
Mean (Standard Deviation)
Unit of Measure: percentage of change from baseline
7.2  (2.3)
3.Secondary Outcome
Title Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 8 Weeks Compared to Baseline
Hide Description

Excess retinal thickening 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.

Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methotrexate
Hide Arm/Group Description:
Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
Overall Number of Participants Analyzed 2
Mean (Standard Deviation)
Unit of Measure: percentage of change from baseline
9.9  (2.3)
4.Secondary Outcome
Title Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 12 Weeks Compared to Baseline
Hide Description

Excess retinal thickening 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.

Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methotrexate
Hide Arm/Group Description:
Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
Overall Number of Participants Analyzed 2
Mean (Standard Deviation)
Unit of Measure: percentage of change from baseline
6.1  (6.6)
5.Secondary Outcome
Title Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 16 Weeks Compared to Baseline
Hide Description

Excess retinal thickening 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.

Time Frame Baseline and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methotrexate
Hide Arm/Group Description:
Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
Overall Number of Participants Analyzed 2
Mean (Standard Deviation)
Unit of Measure: percentage of change from baseline
13.6  (9.3)
6.Secondary Outcome
Title Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 20 Weeks Compared to Baseline
Hide Description

Excess retinal thickening 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.

Time Frame Baseline and Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methotrexate
Hide Arm/Group Description:
Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
Overall Number of Participants Analyzed 2
Mean (Standard Deviation)
Unit of Measure: percentage of change from baseline
4.9  (4.4)
7.Secondary Outcome
Title Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 24 Weeks Compared to Baseline
Hide Description

Excess retinal thickening 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.

Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methotrexate
Hide Arm/Group Description:
Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
Overall Number of Participants Analyzed 2
Mean (Standard Deviation)
Unit of Measure: percentage of change from baseline
10.6  (10.3)
8.Secondary Outcome
Title Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 4 Weeks Compared to Baseline
Hide Description

Central-subfield macular 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.

Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methotrexate
Hide Arm/Group Description:
Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
Overall Number of Participants Analyzed 2
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
2
Mean (Standard Deviation)
Unit of Measure: µm
60.5  (44.5)
9.Secondary Outcome
Title Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 8 Weeks Compared to Baseline
Hide Description

Central-subfield macular 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.

Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methotrexate
Hide Arm/Group Description:
Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
Overall Number of Participants Analyzed 2
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
2
Mean (Standard Deviation)
Unit of Measure: µm
72.0  (19.8)
10.Secondary Outcome
Title Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 12 Weeks Compared to Baseline
Hide Description

Central-subfield macular 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.

Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methotrexate
Hide Arm/Group Description:
Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
Overall Number of Participants Analyzed 2
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
2
Mean (Standard Deviation)
Unit of Measure: µm
99.0  (63.6)
11.Secondary Outcome
Title Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 16 Weeks Compared to Baseline
Hide Description

Central-subfield macular 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.

Time Frame Baseline and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methotrexate
Hide Arm/Group Description:
Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
Overall Number of Participants Analyzed 2
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
2
Mean (Standard Deviation)
Unit of Measure: µm
87.5  (20.5)
12.Secondary Outcome
Title Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 20 Weeks Compared to Baseline
Hide Description

Central-subfield macular 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.

Time Frame Baseline and Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methotrexate
Hide Arm/Group Description:
Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
Overall Number of Participants Analyzed 2
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
2
Mean (Standard Deviation)
Unit of Measure: µm
46.0  (52.3)
13.Secondary Outcome
Title Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 24 Weeks Compared to Baseline
Hide Description

Central-subfield macular 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.

Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methotrexate
Hide Arm/Group Description:
Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
Overall Number of Participants Analyzed 2
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
2
Mean (Standard Deviation)
Unit of Measure: µm
101.0  (118.8)
14.Secondary Outcome
Title Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 4 Weeks 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.

Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methotrexate
Hide Arm/Group Description:
Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
Overall Number of Participants Analyzed 2
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
2
Mean (Standard Deviation)
Unit of Measure: ETDRS Letters
6.0  (4.2)
15.Secondary Outcome
Title Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 8 Weeks 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.

Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methotrexate
Hide Arm/Group Description:
Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
Overall Number of Participants Analyzed 2
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
2
Mean (Standard Deviation)
Unit of Measure: ETDRS Letters
1.5  (2.1)
16.Secondary Outcome
Title Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 12 Weeks 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.

Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methotrexate
Hide Arm/Group Description:
Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
Overall Number of Participants Analyzed 2
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
2
Mean (Standard Deviation)
Unit of Measure: ETDRS Letters
3  (0)
17.Secondary Outcome
Title Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 16 Weeks 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.

Time Frame Baseline and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methotrexate
Hide Arm/Group Description:
Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
Overall Number of Participants Analyzed 2
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
2
Mean (Standard Deviation)
Unit of Measure: ETDRS Letters
1.5  (7.8)
18.Secondary Outcome
Title Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 24 Weeks 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.

Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methotrexate
Hide Arm/Group Description:
Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
Overall Number of Participants Analyzed 2
Mean (Standard Deviation)
Unit of Measure: ETDRS Letters
1.5  (4.9)
19.Secondary Outcome
Title Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 20 Weeks 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.

Time Frame Baseline and Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methotrexate
Hide Arm/Group Description:
Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
Overall Number of Participants Analyzed 2
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
2
Mean (Standard Deviation)
Unit of Measure: ETDRS Letters
1.5  (0.7)
20.Secondary Outcome
Title Number of Participants Presenting No Change in the Area of Leakage in the Study Eye as Seen on Fluorescein Angiography (FA) Imaging at Week 12 as Compared to Baseline
Hide Description

Fluorescein angiography (FA) images were obtained via a standard digital imaging system (OIS, Sacramento, CA). 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.

Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methotrexate
Hide Arm/Group Description:
Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
2
21.Secondary Outcome
Title Number of Participants Presenting No Change in the Area of Leakage in the Study Eye as Seen on Fluorescein Angiography (FA) Imaging at Week 24 as Compared to Baseline
Hide Description

Fluorescein angiography (FA) images were obtained via a standard digital imaging system (OIS, Sacramento, CA). 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.

Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methotrexate
Hide Arm/Group Description:
Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
2
22.Secondary Outcome
Title Number of Participants Presenting the Same Autofluorescence Patterns in the Study Eye as Seen on Fundus Autofluorescence (FAF) Imaging at Week 12 as Observed at Baseline
Hide Description

Fundus autofluorescence patterns were assessed using fundus autofluorescence (FAF) imaging, a non-invasive technique that uses a confocal scanning ophthalmoscope to detect naturally-fluorescing lipofuscin.

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.

Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methotrexate
Hide Arm/Group Description:
Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
2
23.Secondary Outcome
Title Number of Participants Presenting the Same Autofluorescence Patterns in the Study Eye as Seen on Fundus Autofluorescence (FAF) Imaging at Week 24 as Observed at Baseline
Hide Description

Fundus autofluorescence patterns were assessed using fundus autofluorescence (FAF) imaging, a non-invasive technique that uses a confocal scanning ophthalmoscope to detect naturally-fluorescing lipofuscin.

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.

Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methotrexate
Hide Arm/Group Description:
Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
2
24.Secondary Outcome
Title Number of Participants Experiencing a Complete Resolution of Fluid as Seen on OCT at Any Time During the Study Period
Hide Description [Not Specified]
Time Frame Baseline and Week 74
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methotrexate
Hide Arm/Group Description:
Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
0
25.Secondary Outcome
Title Observation of Dose Reduction of Systemic Immunosuppression or Steroids Over the Course of the Study Period
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 Week 74
Hide Outcome Measure Data
Hide Analysis Population Description
As this study terminated early due to lack of recruitment, data were not collected for this outcome.
Arm/Group Title Methotrexate
Hide Arm/Group Description:
Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
26.Secondary Outcome
Title Cytokine Analysis on Aqueous Samples to Assess Whether Intravitreal Injection of Methotrexate Affects Aqueous Inflammatory Cytokine Levels
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 Week 74
Hide Outcome Measure Data
Hide Analysis Population Description
As this study terminated early due to lack of recruitment, data were not collected for this outcome.
Arm/Group Title Methotrexate
Hide Arm/Group Description:
Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Methotrexate
Hide Arm/Group Description Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
All-Cause Mortality
Methotrexate
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Methotrexate
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%
Methotrexate
Affected / at Risk (%) # Events
Total   2/2 (100.00%)    
Eye disorders   
Hypotony of eye  1  1/2 (50.00%)  2
Uveitis  1 [1]  1/2 (50.00%)  1
Infections and infestations   
Ear Infection  1  1/2 (50.00%)  1
Herpes Zoster  1  1/2 (50.00%)  1
Influenza  1  1/2 (50.00%)  1
Staphylococcal skin infection  1  1/2 (50.00%)  1
Urinary tract infection  1  1/2 (50.00%)  1
Injury, poisoning and procedural complications   
Excoriation  1  1/2 (50.00%)  1
Musculoskeletal and connective tissue disorders   
Musculoskeletal chest pain  1  1/2 (50.00%)  1
Tendonitis  1  1/2 (50.00%)  1
Skin and subcutaneous tissue disorders   
Petechiae  1  1/2 (50.00%)  1
Precancerous skin lesion  1  1/2 (50.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
[1]
Worsening of uveitis in the non-study eye
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: H. Nida Sen, MD, MHSc, Principal Investigator, NEI
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: NCT01314417     History of Changes
Other Study ID Numbers: 110107
11-EI-0107 ( Other Identifier: NIH Office of Protocol Services )
First Submitted: March 11, 2011
First Posted: March 14, 2011
Results First Submitted: July 18, 2013
Results First Posted: September 26, 2013
Last Update Posted: March 27, 2019