Clinical Trials

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7 studies in Department of Ophthalmology

  1. Development of Induced Pluripotent Stem Cells From Patients With Best Disease and Other Inherited Retinal Degenerative Diseases.

    Rochester, Minn. View Summary

    Development of Induced Pluripotent Stem Cells From Patients With Best Disease and Other Inherited Retinal Degenerative Diseases.

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The PI on this proposal has been studying BEST1 and the protein encoded (Best1) since its discovery in 1998. Best1 is an integral membrane protein that in the eye is expressed only by retinal pigment epithelial (RPE) cells where it is localized to the basolateral plasma membrane. Methods: Once a subject has been identified as a potential candidate, a study coordinator will meet with the subject, to discuss the study prior to sample collection. The study coordinator will review the consent form with the subject and spend as much time as necessary answering any questions. Once the subject has signed the consent form, study procedures will begin. Following the consent process, a skin sample will be obtained from subjects using a (4mm) dermal punch biopsy method. This will be accomplished in a single visit to the Regenerative Medicine Consult Service or other approved clinical examination room. A suture may need to be placed following this skin biopsy. A health care provider (either at Mayo Clinic or a local health care provider's office) can remove the stitches, or the subject can remove them with a provided disposable suture removal kit. Subjects will also be asked to undergo venipuncture; all subjects will be asked to have the venipuncture and have the option to refuse. 10ml of blood will be collected for RNA and DNA extraction. Once the skin biopsy is obtained,skin fibroblasts will be isolated, which will be reprogrammed into iPSCs. RPE cells will be derived from the iPSCs. Remuneration: If subjects make a special trip only for the research procedures, they may be reimbursed for travel expenses including: airfare, mileage, parking, and hotel. In order to receive reimbursement, they must provide a copy of the original receipts for those expenses. Reimbursement will not exceed $1000.00.

    NCT ID:

    NCT02162953

    IRB Number:

    13-008089

    Who can I contact for additional information about this study?

    Rochester: Lindsay A. Mulvihill, CCRP 507-284-5471
                        


  2. Intense Pulsed Light (IPL) and Meibomian Gland Expression to Treat Ocular Rosacea Secondary to Inactive Chronic Ocular Graft Versus Host Disease (GVHD)

    Phoenix/Scottsdale, Ariz. View Summary

    Intense Pulsed Light (IPL) and Meibomian Gland Expression to Treat Ocular Rosacea Secondary to Inactive Chronic Ocular Graft Versus Host Disease (GVHD)

    Location:

    Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Is Intense Pulsed Light (IPL) treatment and eyelid meibomian gland manual expression safe and effective for allogeneic stem cell transplant patients with ocular rosacea in the setting of quiescent graft-versus-host disease?

    NCT ID:

    NCT02066051

    IRB Number:

    13-003814

    Who can I contact for additional information about this study?


    Scottsdale: Joanne Shen, MD 480-301-8000
                        

  3. A Multicenter, Double-masked, Placebo-controlled, Efficacy and Safety Study of an Insulin-like Growth Factor-1 Receptor (IGF-1R) Antagonist Antibody (Fully Human), in Patients With Active Thyroid Eye Disease

    Rochester, Minn. View Summary

    A Multicenter, Double-masked, Placebo-controlled, Efficacy and Safety Study of an Insulin-like Growth Factor-1 Receptor (IGF-1R) Antagonist Antibody (Fully Human), in Patients With Active Thyroid Eye Disease

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The purpose of this study is to evaluate the safety, tolerability and effectiveness of a fully human antibody compared to placebo in the treatment of patients with active thyroid eye disease.

    NCT ID:

    NCT01868997

    IRB Number:

    13-007171

    Who can I contact for additional information about this study?

  4. Aqueous Humor Dynamic Components That Determine Intraocular Pressure Variance

    Rochester, Minn. View Summary

    Aqueous Humor Dynamic Components That Determine Intraocular Pressure Variance

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Glaucoma is a major cause of blindness. The inability to predict a patient's IOP response to medications is a critical barrier for the clinician to consistently provide highly effective IOP-based treatments. Current trial-and error approaches to glaucoma management are inefficient and have not addressed this barrier as there are no predictive factors for drug response. Our long-term goal is to improve outcomes by identifying biomarkers and environmental factors that profile a patient at risk for glaucoma by age-of-onset, rate of disease progression, "poor response" to treatment, and large IOP fluctuation. Our purpose of this research project is to address this critical barrier by focusing on physiological factors that predict IOP response to drugs.

    NCT ID:

    NCT01677507

    Who can I contact for additional information about this study?

    Rochester: Arthur Sit, MD 507-284-2787
                        Nitika Arora, MBBS 507-284-2787


  5. Effectiveness of Home-Based Therapy for Symptomatic Convergence Insufficiency

    Rochester, Minn. View Summary

    Effectiveness of Home-Based Therapy for Symptomatic Convergence Insufficiency

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Convergence insufficiency (CI) is a common and distinct binocular vision disorder that affects approximately 4% of school age children and adults in the United States. Convergence insufficiency is often associated with symptoms such as frequent loss of place while reading, loss of concentration, having to re-read, reading slowly, poor comprehension, sleepiness, blurred vision, diplopia, headaches, and/or eyestrain. A recently completed randomized clinical trial, the Convergence Insufficiency Treatment Trial (CITT), demonstrated that a 12-week program of office-based vergence/ accommodative therapy with home reinforcement was more effective than home-based near target pencil push-ups, home-based computer accommodative therapy plus pencil push-ups, or office-based placebo therapy in treating the symptoms and signs associated with symptomatic CI in children 9 to 17 years of age. While the home-based therapies in the CITT were not as effective as office-based vergence/accommodative therapy there was some improvement noted. Currently, many eye care professionals only offer home-based therapy, while others suggest passive treatment with base-in prism. At a Pediatric Eye Disease Investigator Group (PEDIG) meeting (Tampa, January 2009), the results of a poll of attendees indicated that a large majority of pediatric ophthalmologists continue to recommend home-based near target push-ups as the initial treatment approach for children with symptomatic CI in spite of the CITT results. There are significant differences in contact time, complexity, and cost between office-based and home-based therapy for CI. Many clinicians believe that the less costly and less complex treatment option should be attempted first. Although home-based therapy using computer software is becoming more popular, no prospective data are available to demonstrate the effectiveness of home-based vision therapy using computer software compared to home-based near target push-ups or home-based placebo computer therapy. A prospective clinical trial is therefore needed to determine the effectiveness of home-based computer therapy for symptomatic CI compared to traditional home-based near target push-ups and placebo treatment. The current study is a multi-center randomized clinical trial to evaluate the effectiveness of home-based computer vergence/accommodative therapy and home-based near target push-ups in children 9 to <18 years of age with symptomatic CI.

    NCT ID:

    NCT01515943

    IRB Number:

    12-001430

    Who can I contact for additional information about this study?

  6. A Randomized Trial of Bilateral Lateral Rectus Recession Versus Unilateral Lateral Rectus Recession With Medial Rectus Resection for Intermittent Exotropia

    Rochester, Minn. View Summary

    A Randomized Trial of Bilateral Lateral Rectus Recession Versus Unilateral Lateral Rectus Recession With Medial Rectus Resection for Intermittent Exotropia

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Intermittent exotropia (IXT) is the most common form of childhood onset exotropia with an incidence of 32.1 per 100,000 in children under 19 years of age. Intermittent exotropia is characterized by an exotropia that is not constant and is mainly present when viewing at distance, but may also be present at near. Normal binocular single vision (BSV) is typically present at near when the exotropia is controlled, with evidence of normal (occasionally sub-normal) stereoacuity. Although the natural history of the condition is largely unknown, many children with IXT are treated using either surgical or non-surgical interventions. The rationale for intervention in childhood IXT is that extended periods of misalignment may lead to entrenched suppression, resulting in loss of BSV. Intervention may also aim to address the social effects caused by the appearance of misaligned eyes. Many children treated for IXT are currently treated surgically. There is poor agreement as to which type of surgery is most effective for the correction of IXT and the debate has long been related to differentiation between IXT sub-types. Based on distance-near angle disparity, IXT sub-types are classified as: 1) basic (similar magnitude of misalignment at distance and near); 2) true divergence excess (larger at distance); 3) pseudo divergence excess (initially larger at distance, but near angle increases following occlusion or with addition of plus lenses at near); 4) convergence insufficiency (larger at near). Basic and pseudo divergence excess appear to be the most common of the sub-types, and are also the types for which there is most disagreement regarding the optimum surgical approach. The two most common procedures are bilateral lateral rectus recession (BLRrec) and unilateral lateral rectus recession combined with a medial rectus resection in the same eye (R&R). Traditionally, BLRrec has been advocated where there is a larger distance angle, and R&R where there is a similar angle at distance and near. A survey of American strabismus surgeons published in 1990 found that the majority performed BLRrec for both basic and divergence excess types. Similarly, we found by polling our investigator group that the majority still perform a BLRrec for basic type IXT. Nevertheless, controversy still exists as to which of these surgical approaches is superior. Advocates of the BLRrec procedure tend to hold that surgery should be based purely on the distance angle of deviation. Proponents of R&R surgery suggest resection of the medial rectus best addresses the exodeviation at near. The proposed advantage of the R&R procedure is that resecting the medial rectus, with a possible longer term initial overcorrection, is necessary for a stable and superior long-term outcome. Nevertheless, those who favor the BLRrec procedure suggest that the more profound and prolonged initial overcorrection occurring with R&R is not only unnecessary, but may in fact be harmful. A persistent overcorrection may be associated with the development of diplopia, amblyopia, and loss of stereoacuity. On the other hand, critics of the BLRrec procedure suggest that long-term recurrence rates are higher. Poor motor outcomes are likely to require reoperation and therefore the long-term success rates of these surgeries have public health importance in terms of cost to society. Evaluating initial and long-term surgical outcomes in the proposed RCT will answer questions regarding the failure rates of these surgeries and also provide needed data on the potential harm of each procedure. Only one prospective randomized clinical trial addresses success rates of BLRrec versus R&R for IXT. After between 12-15 months of follow up, 82% of 17 patients undergoing an R&R had a satisfactory outcome compared to 52% of 19 patients undergoing a BLRrec. Nevertheless, there are some important limitations of this previous study. The sample size was very small. The study population was a sub-group of patients with basic type IXT, excluding patients with basic IXT whose angle of deviation increased at far distance or following occlusion, thus limiting the generalizability of the results. In addition, outcomes were assessed unmasked, potentially biasing the results. One observational study of 103 patients (90% of whom had basic type IXT) found 1-year success rates of 56% for BLRrec and 60% for R&R. A retrospective study of 115 patients with basic type IXT reported success rates of 69% for BLRrec and 77% for R&R after an average of 15 months of follow up. Other studies comparing surgery types are limited not only by retrospective study design but also by inclusion of other types of exotropia, making it difficult to interpret results. In addition, many different criteria for success are used, precluding meaningful comparison of success rates between studies. This lack of evidence makes it very difficult to counsel parents of children with IXT regarding the likely success and complication rate of either procedure, limiting our ability to make informed management decisions. Establishing the respective failure rates through the proposed study will allow physicians to offer patients the type of surgery with the highest chance of long-term success, minimizing suboptimal results and repeat surgeries. The present study is being conducted to compare the effectiveness of BLRrec with R&R for the surgical treatment of basic type and pseudo divergence excess type IXT.

    NCT ID:

    NCT01032603

    IRB Number:

    09-007323

    Who can I contact for additional information about this study?

  7. Randomized Phase II Study Comparing the MET Inhibitor Cabozantinib to Temozolomide/Dacarbazine in Ocular Melanoma

    Rochester, Minn. View Summary

    Randomized Phase II Study Comparing the MET Inhibitor Cabozantinib to Temozolomide/Dacarbazine in Ocular Melanoma

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    PRIMARY OBJECTIVES: I. Compare the progression-free survival rate at 4 months (PFS4) of patients with ocular melanoma treated with cabozantinib (cabozantinib-s-malate) or temozolomide (or dacarbazine). SECONDARY OBJECTIVES: I. Estimate the distribution of progression-free survival (PFS) times. II. Estimate the distribution of overall survival (OS) times. III. Estimate the confirmed response rate as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. IV. Assess the safety of these agents by examining the toxicity profile. V. Correlate the response of mesenchymal-epithelial transition factor (MET) molecular status. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive cabozantinib-s-malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive temozolomide PO daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. If temozolomide is not available, patients receive dacarbazine intravenously (IV) over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. At the time of progression patients may cross-over to Arm I. After completion of study treatment, patients are followed up every 12 weeks for 2 years.

    NCT ID:

    NCT01835145

    IRB Number:

    13-007873

    Who can I contact for additional information about this study?

    Rochester: Robert R. McWilliams 507-538-7623