prednisone and Uveitis, Intermediate studies

Prednisone: A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.
prednisone : A synthetic glucocorticoid drug that is particularly effective as an immunosuppressant, and affects virtually all of the immune system. Prednisone is a prodrug that is converted by the liver into prednisolone (a beta-hydroxy group instead of the oxo group at position 11), which is the active drug and also a steroid.

Uveitis, Intermediate: Inflammation of the pars plana, ciliary body, and adjacent structures.

Research Excerpts

Excerpt	Relevance	Reference
"To compare the benefits of fluocinolone acetonide implant therapy versus systemic corticosteroid therapy supplemented (when indicated) with immunosuppression for intermediate uveitis, posterior uveitis, and panuveitis."	9.20	Benefits of Systemic Anti-inflammatory Therapy versus Fluocinolone Acetonide Intraocular Implant for Intermediate Uveitis, Posterior Uveitis, and Panuveitis: Fifty-four-Month Results of the Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up ( Altaweel, MM; Drye, LT; Holbrook, JT; Jabs, DA; Kempen, JH; Sugar, EA; Thorne, JE, 2015)
"These results suggest that fluocinolone acetonide implant therapy is associated with a clinically important increased risk of glaucoma and cataract with respect to systemic therapy, suggesting that careful monitoring and early intervention to prevent glaucoma is warranted with implant therapy."	9.20	Quality of Life and Risks Associated with Systemic Anti-inflammatory Therapy versus Fluocinolone Acetonide Intraocular Implant for Intermediate Uveitis, Posterior Uveitis, or Panuveitis: Fifty-four-Month Results of the Multicenter Uveitis Steroid Treatmen ( , 2015)
"To compare the relative effectiveness of systemic corticosteroids plus immunosuppression when indicated (systemic therapy) versus fluocinolone acetonide implant (implant therapy) for noninfectious intermediate, posterior, or panuveitis (uveitis)."	9.15	Randomized comparison of systemic anti-inflammatory therapy versus fluocinolone acetonide implant for intermediate, posterior, and panuveitis: the multicenter uveitis steroid treatment trial. ( Altaweel, MM; Holbrook, JT; Jabs, DA; Kempen, JH; Louis, TA; Sugar, EA; Thorne, JE, 2011)
"To compare the benefits of fluocinolone acetonide implant therapy versus systemic corticosteroid therapy supplemented (when indicated) with immunosuppression for intermediate uveitis, posterior uveitis, and panuveitis."	5.20	Benefits of Systemic Anti-inflammatory Therapy versus Fluocinolone Acetonide Intraocular Implant for Intermediate Uveitis, Posterior Uveitis, and Panuveitis: Fifty-four-Month Results of the Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up ( Altaweel, MM; Drye, LT; Holbrook, JT; Jabs, DA; Kempen, JH; Sugar, EA; Thorne, JE, 2015)
"These results suggest that fluocinolone acetonide implant therapy is associated with a clinically important increased risk of glaucoma and cataract with respect to systemic therapy, suggesting that careful monitoring and early intervention to prevent glaucoma is warranted with implant therapy."	5.20	Quality of Life and Risks Associated with Systemic Anti-inflammatory Therapy versus Fluocinolone Acetonide Intraocular Implant for Intermediate Uveitis, Posterior Uveitis, or Panuveitis: Fifty-four-Month Results of the Multicenter Uveitis Steroid Treatmen ( , 2015)
"To compare the relative effectiveness of systemic corticosteroids plus immunosuppression when indicated (systemic therapy) versus fluocinolone acetonide implant (implant therapy) for noninfectious intermediate, posterior, or panuveitis (uveitis)."	5.15	Randomized comparison of systemic anti-inflammatory therapy versus fluocinolone acetonide implant for intermediate, posterior, and panuveitis: the multicenter uveitis steroid treatment trial. ( Altaweel, MM; Holbrook, JT; Jabs, DA; Kempen, JH; Louis, TA; Sugar, EA; Thorne, JE, 2011)
"Chronic use of corticosteroids for the treatment of uveitis has been linked with drug-associated toxicity and adverse events (AEs)."	2.84	Corticosteroid-Related Adverse Events Systematically Increase with Corticosteroid Dose in Noninfectious Intermediate, Posterior, or Panuveitis: Post Hoc Analyses from the VISUAL-1 and VISUAL-2 Trials. ( Bao, Y; Betts, KA; Camez, A; Joshi, A; Mittal, M; Suhler, EB; Tari, S; Thorne, JE, 2017)
"This study causally examined the dose-response relationship between oral corticosteroids (OCS) exposure and long-term complications among noninfectious uveitis adult patients in the United States."	1.51	Oral corticosteroid exposure and increased risk of related complications in patients with noninfectious intermediate, posterior, or panuveitis: Real-world data analysis. ( Chirikov, VV; Kwon, Y; Patel, D; Shah, R, 2019)

Research

Studies (8)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

Cataract - Incident Cataract

Change in Best-corrected Visual Acuity (Change in the Numbers of Letters Read From a Standard ETDRS Eye Chart) From Baseline to 24 Months in Eyes With Uveitis

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	1 (12.50)	29.6817
2010's	7 (87.50)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Cadieux, D	1
Gupta, R	1
Suhler, EB	1
Thorne, JE	3
Mittal, M	1
Betts, KA	1
Tari, S	1
Camez, A	1
Bao, Y	1
Joshi, A	1
Biancardi, AL	1
Moraes, HV	1
Chirikov, VV	1
Shah, R	1
Kwon, Y	1
Patel, D	1
Kempen, JH	2
Altaweel, MM	2
Drye, LT	1
Holbrook, JT	2
Jabs, DA	2
Sugar, EA	2
Louis, TA	1
Heinz, C	1
Heiligenhaus, A	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Multicenter Uveitis Steroid Treatment (MUST) Trial[NCT00132691]	Phase 4	255 participants (Actual)	Interventional	2005-09-30	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Intervention	percentage of eyes with uveitis at risk (Number)
Fluocinolone Acetonide Implant	90.7
Systemic Therapy	44.9

Best-corrected visual acuity was measured as the number of letters read from standard logarithmic visual acuity charts by study-certified examiners who were masked to treatment. Visual acuity was measured at all study visits. The primary outcome was eye-specific change in visual acuity from baseline to 2-year follow-up. Positive change values indicate improved vision while negative change values indicate vision has gotten worse. A change of 7.5 letters is considered clinically meaningful. (NCT00132691)
Timeframe: 24 months

Change in Self-reported Vision-related Function as Measured by the National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ 25) Vision Targeted Composite Score From Baseline to 24 Months

Intervention	letters (Mean)
Flucinolone Acetonide Implant	6.0
Systemic Therapy	3.2

The NEI-VFQ 25 measures the effect of visual disability/symptoms with generic health and task-oriented domains. The range for the composite score is 0 to 100; higher scores are associated with better visual function. A change of 4 to 6 points is considered to be a clinically meaningful difference. (NCT00132691)
Timeframe: 24 months

Change in SF-36 Mental Component Score From Baseline to 24 Months

Intervention	units on a scale (composite score) (Mean)
Fluocinolone Acetonide Implant	11.44
Systemic Therapy	6.80

Self-reported health related QoL was measured with the SF 36 survey. The mental component score for the SF 36 is a summary measure of mental health primarily based on the social functioning, role emotional, mental health and vitality domains. The score is scaled to a population norm with a mean of 50 and standard deviation of 10. Higher scores represent better outcomes. The mean change in scores between baseline and 24 months was calculated for each treatment group. (NCT00132691)
Timeframe: 24 months

Change in SF-36 Physical Component Score From Baseline to 24 Months

Intervention	units on a scale (Mean)
Flucinolone Acetonide Implant	2.55
Systemic Therapy	-1.1

Self-reported health related QoL was measured with the SF 36 survey. The physical component score for the SF 36 is a summary measure of physical health primarily based on the physical functioning, role physical, bodily pain and general health domains of the survey. The score is scaled to a population norm with a mean of 50 and standard deviation of 10. Higher scores represent better outcomes. The mean change in scores between baseline and 24 months was calculated for each treatment group. A 3 to 5 point difference is considered to be clinically meaningful. (NCT00132691)
Timeframe: 24 months

Diabetes Mellitus

Glaucoma - Incident

Intervention	units on a scale (Mean)
Flucinolone Acetonide Implant	1.15
Systemic Therapy	-1.8

Intervention	percentage of participants (Number)
Flucinolone Acetonide Implant	1.0
Systemic Therapy	3.6

Glaucoma was diagnosed by a glaucoma specialist through review of visual fields, clinical data, and fundus images. (NCT00132691)
Timeframe: 24 months

Hyperlipidemia - Incident

Hypertension Diagnosis Requiring Treatment

Intraocular Pressure - Incident IOP Elevation >= 10 mmHg Above Baseline

Intraocular Pressure - Incident IOP Greater Than or Equal to 24 mm Hg

Intraocular Pressure - Incident IOP Greater Than or Equal to 30 mm Hg

Intraocular Pressure - IOP-lowering Surgery

Intraocular Pressure (IOP) - Incident Use of IOP-lowering Medical Therapy (Percentage of Eyes With Uveitis That Were Not Being Treated With IOP-lowering Medical Therapy at Baseline and Underwent IOP Lowering Therapy During the 24 Month Follow-up.

Intervention	percentage of eyes with uveitis at risk (Number)
Fluocinolone Acetonide Implant	16.5
Systemic Therapy	4.0

Intervention	percentage of participants at risk (Number)
Flucinolone Acetonide Implant	9.8
Systemic Therapy	11.0

Intervention	percentage of participants (Number)
Flucinolone Acetonide Implant	4.6
Systemic Therapy	10.5

Intervention	percentage of eyes with uveitis at risk (Number)
Fluocinolone Acetonide Implant	51.8
Systemic Therapy	15.5

Intervention	percentage of eyes with uveitis at risk (Number)
Flucinolone Acetonide Implant	53.1
Systemic Therapy	18.7

Intervention	percentage of eyes with uveitis at risk (Number)
Flucinolone Acetonide Implant	32.8
Systemic Therapy	6.3

Intervention	percentage of eyes with uveitis at risk (Number)
Flucinolone Acetonide Implant	26.2
Systemic Therapy	3.7

The percentage of subjects who used topical or systemic treatment for elevated IOP at any time during the 2 year follow-up and were not on IOP-lowering therapy at baseline is reported. (NCT00132691)
Timeframe: 24 months

Macular Edema

Intervention	percentage of eyes with uveitis at risk (Number)
Flucinolone Acetonide Implant	61.1
Systemic Therapy	20.1

center point macular thickness >= 240 micrometers assessed on OCT (Stratus OCT-3 [Carl Zeiss Meditec, Dublin, CA]) as graded by Central Reading Center (NCT00132691)
Timeframe: 24 months

Mortality

Uveitis Activity

Intervention	percentage of eyes with uveitis (Number)
Flucinolone Acetonide Implant	22
Systemic Therapy	30

Intervention	percentage of participants (Number)
Flucinolone Acetonide Implant	1.6
Systemic Therapy	0

Uveitis activity was determined by clinician assessment at each study visit. The study ophthalmologist evaluated each eye as active, inactive/never had uveitis or cannot assess. (NCT00132691)
Timeframe: 24 months

Article	Year
Corticosteroid-Related Adverse Events Systematically Increase with Corticosteroid Dose in Noninfectious Intermediate, Posterior, or Panuveitis: Post Hoc Analyses from the VISUAL-1 and VISUAL-2 Trials. Ophthalmology, 2017, Volume: 124, Issue:12 Topics: Adalimumab; Administration, Oral; Adult; Anti-Inflammatory Agents; Double-Blind Method; Drug Combina	2017
Benefits of Systemic Anti-inflammatory Therapy versus Fluocinolone Acetonide Intraocular Implant for Intermediate Uveitis, Posterior Uveitis, and Panuveitis: Fifty-four-Month Results of the Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Ophthalmology, 2015, Volume: 122, Issue:10 Topics: Adult; Aged; Anti-Inflammatory Agents; Drug Implants; Female; Fluocinolone Acetonide; Follow-Up Stud	2015
Quality of Life and Risks Associated with Systemic Anti-inflammatory Therapy versus Fluocinolone Acetonide Intraocular Implant for Intermediate Uveitis, Posterior Uveitis, or Panuveitis: Fifty-four-Month Results of the Multicenter Uveitis Steroid Treatmen Ophthalmology, 2015, Volume: 122, Issue:10 Topics: Adult; Aged; Anti-Inflammatory Agents; Cataract; Drug Implants; Female; Fluocinolone Acetonide; Foll	2015
Randomized comparison of systemic anti-inflammatory therapy versus fluocinolone acetonide implant for intermediate, posterior, and panuveitis: the multicenter uveitis steroid treatment trial. Ophthalmology, 2011, Volume: 118, Issue:10 Topics: Drug Implants; Drug Therapy, Combination; Female; Fluocinolone Acetonide; Glucocorticoids; Humans; I	2011

Article	Year
Sarcoidosis presenting with intermediate uveitis and subcutaneous nodules. CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 2019, Sep-09, Volume: 191, Issue:36 Topics: Angiotensin-Converting Enzyme Inhibitors; Anti-Inflammatory Agents; Fatigue; Female; Humans; Middle	2019
Anterior and Intermediate Uveitis Following Yellow Fever Vaccination with Fractional Dose: Case Reports. Ocular immunology and inflammation, 2019, Volume: 27, Issue:4 Topics: Administration, Oral; Adult; Dexamethasone; Female; Fluorescein Angiography; Fundus Oculi; Glucocort	2019
Oral corticosteroid exposure and increased risk of related complications in patients with noninfectious intermediate, posterior, or panuveitis: Real-world data analysis. Ophthalmic epidemiology, 2019, Volume: 26, Issue:1 Topics: Administration, Oral; Data Analysis; Dose-Response Relationship, Drug; Drug-Related Side Effects and	2019
Improvement of noninfectious uveitis with fumaric acid esters: results of a pilot study. Archives of ophthalmology (Chicago, Ill. : 1960), 2007, Volume: 125, Issue:4 Topics: Adult; Dimethyl Fumarate; Drug Therapy, Combination; Female; Fluorescein Angiography; Fumarates; Glu	2007

prednisone and Uveitis, Intermediate