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8 Study Matches

Efficacy and Safety Study as Monotherapy of SA237 to Treat NMO and NMOSD

The objective of this study is to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic and immunogenic profiles of SA237 in patients with NMO and NMOSD
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Benjamin Greenberg
105091
All
18 Years to 74 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT02073279
STU 092014-086
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Inclusion Criteria:

• 1. NMO or NMOSD
• 2. Age 18 to 74 years, inclusive at the time of informed consent.
Exclusion Criteria:

• 1. Pregnancy or lactation.
• 2. Evidence of other demyelinating disease or PML.
• 3. Known active infection (excluding fungal infections of nail beds or caries dentium) within 4 weeks prior to baseline.
Drug: satralizumab (SA237), Drug: Placebo
Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)
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Zoster Eye Disease Study (ZEDS)

Call 214-648-5005
studyfinder@utsouthwestern.edu
James McCulley
14755
All
18 Years and over
Phase 4
This study is NOT accepting healthy volunteers
NCT03134196
STU 052017-007
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PARTICIPANT INCLUSION CRITERIA To be eligible for study participation, an individual must meet all of the following criteria: 1. Ability to understand, and willingness and ability to read and sign, the informed consent form. 2. Ability to understand and follow instructions and study procedures. 3. Willingness to comply with all study procedures and be available for the duration of the study. 4. Ability to take oral medication, and are willing to adhere to study medication regimen. 5. Age 18 years or older. 6. Diagnosed with HZO in one eye based on both of these criteria: 1. History of characteristic unilateral vesicular rash in the dermatomal distribution of cranial nerve V1. 2. Medical record documentation of an episode of active dendriform epithelial keratitis, stromal keratitis, endothelial keratitis, and/or iritis due to HZO within the preceding year. This episode of active anterior segment ocular disease may be due to HZO of recent onset (within the preceding 6 months); or chronic HZO (with onset six or more months ago); may be new, worsening, or recurrent disease after a period of inactivity; and may occur after medication was reduced. i. Study participants with chronic HZO must be on a stable treatment regimen and off antivirals for at least 30 days before enrollment. Study participants with chronic HZO who do not meet this criterion may be rescreened, if they are able to meet this criterion within 3 months after the study visit. (This is not a requirement for study participants with recent onset HZO, who may be enrolled at any time, preferably after completing recommended acute antiviral treatment, if prescribed, is completed). 7. For females with reproductive potential, willingness to use highly effective contraception (e.g., hormonal contraception, barrier contraception, intrauterine device, or abstinence). PARTICIPANT EXCLUSION CRITERIA An individual who meets any of the following criteria will be excluded from participation in this study: 1. History of immunocompromised status as defined by current CDC contraindications for the vaccine against zoster (44). 1. Study participants who are diagnosed with leukemia, lymphomas or other malignant neoplasms affecting bone marrow or lymphatic system, unless leukemia in remission and off chemotherapy for at least 3 months. 2. Study participants who are diagnosed with Acquired Immune Deficiency Syndrome (AIDS) or presents with other clinical manifestations of Human Immunodeficiency virus (HIV) including CD4 count of ≤ 200 cells/ml. 3. Study participants on immunosuppressive therapy including: i. High-dose corticosteroids (greater than equivalent of prednisone 20 mg/day within 1 month) ii. Chemotherapy, other than low dose used for treatment of immune-mediated diseases within 3 months iii. Study participants receiving recombinant human immune mediators and immune modulators, especially antitumor necrosis agents, within 1 month prior to enrollment d. Study participants with unspecified cellular immunodeficiency. e. Study participants with history of hematopoietic stem cell transplantation. 2. Medical history of a systemic disease and thought likely to meet one of the exclusion criteria listed in exclusion criterion #1 during the 18-month study period. 3. Renal insufficiency: 1. Requires dialysis or has history of renal transplant or 2. eGFR less than 45, determined within 30 days preceding enrollment. 4. Allergy or adverse reaction to valacyclovir or acyclovir. 5. History of vaccination against zoster within one month prior to enrollment. Study participants who meet this exclusion criterion may be rescreened. 6. Keratoplasty or keratorefractive surgery of the involved eye with zoster. 7. On systemic antivirals with activity against herpes within the past 30 days, including acyclovir, valacyclovir, or famciclovir, for any reason except for treatment of acute HZO, including investigational drug trial. 8. History of another condition that may require treatment with one of these three antivirals listed above in exclusion criterion #7, during the course of the study; study participants who require chronic suppressive antiviral treatment with these medications will be excluded. 9. Sexually active women who are pregnant, nursing, or in their reproductive years who do not agree to use contraception during the 1-year treatment period. 10. Incarceration 11. Any condition or circumstance that in the opinion of the study investigator, would place the study participant in increased risk or affect his/her full compliance or completion of the study. 12. Participation in a clinical study testing a drug, biologic, device or other intervention within the last 30 days from enrollment visit. Study participants who meet this criterion may be rescreened.
Drug: Masked Placebo, Drug: Masked Oral Valacyclovir
Herpes Zoster Ophthalmicus
Herpes Zoster Ophthalmicus, Zoster Eye Disease Study, Varicella Zoster Virus, Zoster, Shingles
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Inositol to Reduce Retinopathy of Prematurity (INS-3)

This is a Phase 3, randomized, double-masked, placebo-controlled study designed to determine the effectiveness of myo-Inositol 5% Injection to increase the incidence of survival without severe Retinopathy of Prematurity (ROP) through acute/final ROP determination up to 55 weeks postmenstrual age (PMA) in premature infants <28 0/7 weeks' gestation.
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studyfinder@utsouthwestern.edu
Myra Wyckoff
19272
All
up to 72 Hours old
Phase 3
This study is NOT accepting healthy volunteers
NCT01954082
STU 012014-069
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Inclusion Criteria:

• Inborn or out born infants of either gender or any race with best obstetrical estimate of gestation <28 weeks (27 6/7 weeks and younger). Gestational age will be determined by best obstetrical estimate using the hierarchy of best obstetrical estimate using early ultrasound dating, maternal menstrual dating confirmed by examination, or neonatal gestational age assessment by physical examination.
• Alive at 12 hours.
• Age in hours up to 72 hours, although we will seek enrollment as early as feasible after consent and 12 hours.
• Informed consent signed and dated by parent and/or guardian, which includes likelihood of completing follow-up ophthalmic examinations as an outpatient, and long-term follow-up. Exclusion Criteria
• Major congenital malformations
• Congenital malformations of the eye identified prior to randomization.
• Overt evidence of intrauterine congenital infections ("TORCH") or life threatening impairment of renal, hepatic, or cardiac function (considered moribund).
Drug: myo-Inositol 5% Injection, Drug: Placebo
Retinopathy of Prematurity (ROP)
Retinopathy, Prematurity, Infant, Newborn, Diseases
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Intacs for Keratoconus

The US food and Drug Administration (FDA) originally approved INTACS prescription inserts in April 1999 for the correction of low levels of nearsightedness (-1.00 to -3.00 diopters). Additional clinical data have shown that INTACS are safe for the treatment of keratoconus, in July 2004, FDA approved INTACS inserts for the treatment of keratoconus as a Humanitarian Use Device (FDA approval letter attached). The statute and the implementing regulation of FDA (21 CFR 814.124 (aj) require IRB review and approval before a HUD is used.INTACS prescription inserts are composed of two clear segments, each having an arc length of 150°, they are manufactured form a biomedical material called polymethylmethacrylate (PMMA) and are available in three thicknesses. Two INTACS inserts ranging from 0.250mm to 0.350mm may be implanted depending on the orientation of the cone and the amount of myopia and astigmatism to be reduced.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Steven Verity
53988
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02138669
STU 012011-115
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Inclusion Criteria:
Who have experienced a progressive deterioration in their vision, such thot they can no longer achieve adequate functional vision on a daily basis with their contact lenses or spectacles; Who are 21 years of age or older; Who have clear central corneas; Who have a corneal thickness of 450 microns or greater at the proposed incision site; Who have corneal transplantation as the only remaining option to improve their functional vision.
Exclusion Criteria:
Who have abnormally thin corneas or who have a corneal thickness of 449 microns or less at the proposed incision site; Patients with collagen vascular, autoimmune or immunodeficiency disease; Pregnant or nursing patients; Presence of ocular conditions, such as recurrent corneal erosion syndrome or corneal dystrophy, that my predispose the patient to future complications; Patients who are taking on or more of following medications: isotretinoin (Accutane); amiodarone HCL (Cordarone).
Device: Intacs
Keratoconus
Cornea, Keratoconus, Steep cornea
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DAILIES TOTAL1 Versus ACUVUE TruEye (TruEyeTotal1)

This is a prospective, single center, randomized, bilateral crossover, dispensing clinical trial to evaluate the effects of the water gradient lens, DAILIES TOTAL1, on the biology of corneal epithelium over two months of daily wear compared to wear of a control high oxygen permeable silicone hydrogel daily disposable contact lens, the ACUVUE TruEye; and to correlate these changes with alterations in the lid wiper, tear film and cellular changes at the limbus. The total proposed duration of this study is 12 months to ensure enrollment of up to 94 established contact lens wearers, with anticipated completion of 84. Data will be collected at baseline and following 2 months of daily wear for each lens type. Based upon data from the investigators previous contact lens clinical trials, a 1 month washout period is required prior to initiating lens wear to eliminate any potential residual solution or lens effects on the corneal epithelium and restore homeostasis. The study is scheduled to commence upon Institutional Review Board approval.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Danielle Robertson
54987
All
21 Years to 38 Years old
N/A
This study is also accepting healthy volunteers
NCT02347631
STU 112014-068
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Inclusion Criteria:

• Aged 21-38 years
• Any sex, race or national origin accepted as with our past studies. Minority representation will be proactively encouraged
• Sign written informed consent
• A habitual contact lens wearer and only wear lenses for daily wear use (no overnight wear)
• Myopia range: -1.00 to -6.00 with regular astigmatism (≤1 Diopter, both eyes)
• Be willing to wear spectacles for two 1-month washout periods
• Have acceptable fit with test lenses and be willing to wear lenses for the duration of the study.
• Need correction in both eyes and be correctable to within 3 letters (high contrast Snellen VA) of their current contact lens prescription at baseline in each eye with the test lenses.
• No history of allergic eye disease either seasonal or associated with previous contact lens wear.
• A routine screening complete ocular examination (COE) with ocular findings considered to be within normal limits.
• Be willing and able to follow instructions regarding the wear of the daily disposable lenses and attend the scheduled follow-up visits.
• Must be able to arrange weekday appointments between 8:00 (morning) and 12:00 (noon).
Exclusion Criteria:

• Habitual lens wearers unable to wear lenses for a minimum of 8 hours per day.
• Use of concurrent ocular medication
• Habitual toric or bifocal contact lens wearers
• Any previous history of keratorefractive surgery or recent ocular injuries or ocular surgery within the prior 3 months
• Any preexisting ocular disease
• Monocular contact lens wear
• Any systemic disease or ocular abnormality that may impact optimal contact lens wear
• Use of systemic medications including but not limited to antihistamines, corticosteroids, anticholinergics or immunomodulatory agents
• Pregnancy or lactation
• Concurrent enrollment in another clinical trial
Device: Soft Contact Lens - Daily Disposable Alcon Dailies Total 1, Device: Acuvue TruEye
Soft Contact Lenses, Myopia
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Artisan Aphakia Lens for the Correction of Aphakia in Children

The purpose of this study is to determine the safety and effectiveness of the Artisan Aphakia Lens in the treatment of aphakia in children.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Serena Wang
33601
All
2 Years to 21 Years old
Phase 3
This study is also accepting healthy volunteers
NCT01547442
STU 082013-072
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Inclusion Criteria:

• 2 to 21 years of age
• Have a visually significant cataract or need IOL replacement surgery
• Compromised capsular bag prohibiting implantation of standard posterior IOL
• Subject or parent/guardian must be able to comply with visit schedule and study requirements
• Subject's legal representative must be able to sign the Informed Consent
Exclusion Criteria:

• Under 2 years of age
• Unable to meet Postoperative evaluation requirements
• No useful vision or vision potential in fellow eye
• Mentally retarded patients
• History of corneal disease
• Abnormality of the iris or ocular structure
• ACD less than 3.2 mm
• Uncontrolled glaucoma
• IOP > 25 mmHg
• Chronic or recurrent uveitis
• Preexisting macular pathology that may complicate the ability to assess the benefit of this lens
• Retinal detachment or family history
• Retinal disease that may limit visual potential
• Optic nerve disease that may limit visual potential
• Diabetes mellitus
• Pregnant, lactating or plan to become pregnant
Device: Artisan Aphakia Intraocular Lens
Aphakia
aphakia, secondary intraocular lens, congenital cataract, marfan syndrome, pediatric cataract, ectopia lentis, subluxated lens
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Diabetic Retinopathy And the Myvisiontrack® (DRAMA) Study (DRAMA)

The purpose of this study is to determine the effect of enhancements to the myVisionTrack® in regards to patient compliance and test-retest variability. Additionally, the ability of myVisionTrack® to detect changes in vision function will be evaluated.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Yi-Zhong Wang
44378
All
40 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT01728883
STU 022013-007
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Inclusion Criteria:

• DR or AMD requiring treatment at time of study initiation
• Macular edema involving the central subfield based on clinical judgment
• No noticeable central subfield atrophy
• Patients willing and able to comply with all study and follow-up procedures (including the handling of the myVisionTrack™ device)
Exclusion Criteria:

• Any ocular pathology other than DR or AMD
• Any other concurrent systemic illness affecting the retina and visual function
• Dementia or other neurological or psychological limitation that would prevent patients from performing self-testing of visual function
• Past (within the prior 6 months) or current use of, or likely need for, systemic medications that are known to be toxic to the lens, retina, or optic nerve
• Use of investigational drugs at the time of screening, or within 60 days (excluding vitamins and minerals)
• Pregnancy
Device: Home vision monitoring using myVisionTrack®
Diabetic Retinopathy, Diabetic Macular Edema
Diabetic Retinopathy, Diabetic Macular Edema, Macular Edema, Maculopathy, home monitoring, shape discrimination hyperacuity, Psychophysical Testing
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Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA®

To show the non-inferiority of EGRIFTA® vs. placebo in the development or progression of Diabetic Retinopathy in HIV-infected subjects with concomitant abdominal lipohypertrophy and Type 2 diabetes mellitus (T2DM).
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Mamta Jain
41138
All
18 Years and over
Phase 4
This study is NOT accepting healthy volunteers
NCT01591902
STU 062012-099
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Inclusion criteria: 1. Subject has given written informed consent and is willing to comply with the requirements of the protocol; 2. Subject is an adult man or woman (≥ 18 years old); 3. Subject has laboratory confirmed HIV infection; 4. Subject is receiving ART that has been stable for at least 8 weeks prior to screening; 5. Subject has physical evidence of abdominal lipohypertrophy, as determined by the examining study physician; 6. Subject has T2DM as determined by previous HbA1c ≥ 6.5%, previous fasting plasma glucose
• ≥ 126 mg/dL (7.0 mmol/L), and/or previous 2-hour plasma glucose ≥ 200 mg/dL (11.1 mmol/L) during oral glucose tolerance testing (OGTT), and/or previous random plasma glucose ≥ 200 mg/dL (11.1 mmol/L) with symptoms of uncontrolled DM;
• if subject has been diagnosed with T2DM and is on glucose lowering medications for greater than 1 year the above glucose parameters do not apply; 7. Subject, at the time of screening, has HbA1c between 6.0% and 12.0%; 8. Subject's diabetes has been treated for at least 1 year by diet alone, individuals who are on a stable dose (at least 3 months) of insulin, an OHA, or a GLP-1 analogue plus insulin to control diabetes are permitted if their HbA1C is below 6.0%. OHA, GLP-1 analogue, or OHA/GLP-1 analogue plus insulin according to current American Diabetes Association (ADA) guidelines, and doses have been stable for at least 3 months; 9. If the subject is using lipid lowering drugs, the dose must be stable for at least 2 months prior to screening; 10. Subject must have an electrocardiogram (ECG) without clinically significant abnormalities within 6 months prior to screening; 11. Pre-menopausal women of childbearing potential are eligible only if they are not pregnant (negative urine pregnancy tests at screening and baseline) or lactating and are using an acceptable form of birth control prior to study entry and for at least 2 months after completing treatment. Acceptable contraception is defined as two barrier methods, or one barrier method with a spermicide, or an intrauterine device, or an oral contraceptive; 12. Women of non-childbearing potential must be post-menopausal (no menses for more than 1 year) or surgically sterile (tubal ligation or hysterectomy); 13. Women over 40 years old must have a negative mammogram within 6 months prior to screening or a mammogram will be taken at screening; 14. Men must have a normal prostate exam and a prostate specific antigen (PSA) Individuals who are on a stable dose (at least 3 months) of insulin, less than or equal to 5 ng/mL within 6 months prior to screening or PSA and, for men 50 years of age or older, a prostate specific antigen will be measured at screening
Exclusion Criteria:
1. Subject has Type 1 DM; 2. Subject has body mass index (BMI) < 18.5 kg.m2; 3. Subject has or has had an opportunistic infection or acquired immune deficiency syndrome (AIDS)-defining illness within 3 months of screening; 4. Subject has or has had a malignancy or, for women, personal or family (first degree relative) history of breast cancer. Exceptions are basal cell carcinoma, in situ carcinoma of the cervix, in situ anal carcinoma, treated and stable cutaneous squamous cell carcinoma. and stable Kaposi's sarcoma; 5. Pre-existing PDR or severe non-PDR (NPDR), defined as an ETDRS level of ≥ 53 in either eye; 6. Subject has or has had cytomegalovirus (CMV) retinitis, toxoplasmosis, or any other ocular infection that would prevent evaluation of DR; 7. Subject has previously been treated for DR (treatments such as laser photocoagulation, intravitreal injection, or vitrectomy); 8. Subject has any of the following illnesses or conditions: 1. hypopituitarism, history of pituitary tumor or pituitary surgery; 2. untreated hypothyroidism; 3. head irradiation or head trauma that has affected the somatotropic axis; 4. uncontrolled hypertension, defined as systolic pressure > 140 mm Hg and diastolic pressure > 90 mm Hg; 5. unstable CV condition, defined as: i. acute MI; ii. unstable angina; iii. decompensated congestive heart failure (CHF, new onset or exacerbation); iv. stroke; v. history of any of the above within 6 months prior to screening; f. hepatic abnormality, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of normal (3 x ULN); g. renal abnormality, defined as serum creatinine > 2 x ULN; h. lipid metabolism abnormality, defined as fasting triglycerides > 1500 mg/dL; i. anemia, defined as hemoglobin ≤ 7 g/dL; 9. Drug or hormone use as follows 1. Men: change in regimen or supraphysiological dose of testosterone within 2 months prior to screening; 2. anabolic steroids, GH, GH secretagogue, GHRF products or analogs (including EGRIFTA®), IGF-1, or IGF binding protein 3 (IGFBP 3) within 6 months prior to screening; 10. Drug or alcohol dependence within 6 months prior to screening; 11. Subject is using or has used anorectics, anorexigenics, or anti-obesity agents within 3 months prior to screening; 12. Subject is pregnant or nursing; 13. Other significant disease that, in the Investigator's opinion, would exclude the subject from the trial; 14. Participation, within 30 days prior to screening, in another clinical trial of an investigational agent that could affect IGF-1 levels; 15. Known hypersensitivity to the study drug treatments.
Drug: Tesamorelin, Drug: Placebo-Control
HIV, Diabetic Retinopathy
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