Clinical Research Trials at the Eye Institute
Patients benefit from the Eye Institute’s involvement in numerous Food and Drug Administration (FDA) national clinical research trials. Providing access to these national studies keeps the community updated on the latest medical and surgical advances in eye care. The FDA regulates the clinical trials offered at the Eye Institute to protect our patient’s rights, safety, and welfare. We offer clinical trials that explore the latest treatments for macular degeneration, diabetic retinopathy, macular edema, uveitis, dry eye, high eye pressure, and many others. The physicians at Black Hills Regional Eye Institute in Rapid City, South Dakota have been participating in clinical trials for several years.
Why Participate in a Clinical Research Trial
Patients who qualify can take advantage of new cutting-edge therapies at no cost. A patient will benefit from a treatment or drug therapy that is not yet available to the public. To begin the process, a patient must start with an evaluation to see if he qualifies for the study. If accepted into a study the patient will be expected to meet certain criteria for the study and will need to complete a few to several visits related to the study. During these visits, a patient will receive tests, treatments, and drug therapy at no cost. Some patients will receive the actual drug the clinical research trial is testing and others will receive a placebo drug. Either way, the doctor participating in the trial is not aware of which drug therapy a patient is receiving.
Active Trials Enrolling Patients
Currently Enrolling Studies
Prevent – A multicenter, prospectively randomized, masked and controlled, investigator-sponsored phase I/II study to see if Ranibizumab can safely and effectively prevent the conversion of dry to wet AMD in eyes at increased risk of conversion. The study will compare giving ranibizumab to not giving ranibizumab. (2-year trial)
Retinal Vein Occlusion:
Clearside Sapphire – Phase 3 study determining the safety and efficacy of Suprachoroidal CLS-TA in combination with Intravitreal Aflibercept in subjects with retinal vein occlusion. (1-year trial)
Panorama – Phase 3 study of the efficacy and safety of IVT Aflibercept injection in patient with moderately severe to severe nonproliferative diabetic retinopathy. (2-year trial)
Circle – Phase 2 multicenter study to evaluate the efficacy and safety of ocriplasmin in inducing total posterior vitreous detachment (PVD) in subjects with non-proliferative diabetic retinopathy (2-year trial)
*Please Contact Leah Callahan at 719-3320 if you would like more information or have patients for any of the studies listed above.
A Phase 3, Multi-Center, Randomized, Double Masked, Placebo controlled Clinical Study to Assess the Safety and Efficacy of 0.1% RGN Ophthalmic Solution for the Treatment of Neurotrophic Keratopathy
Dry Eye Syndrome:
Kala Pharmaceuticals, Inc.
A Phase 3, Double-Masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle in Subjects with Dry Eye Disease
Sjogren’s dry eye patients:
A Double-Masked, Randomized, Multi-Center Phase 2 Study to Evaluate the Efficacy and Safety of Lacripep in Subjects with Dry Eye Associated with Sjogren’s Syndrome
Viral and Bacterial conjunctivitis:
A Phase 3, Multi-Center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to PVP-Iodine and Placebo in the Treatment of Adenoviral Conjunctivitis
A Phase 3, Multi-Center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to Placebo in the Treatment of Bacterial Conjunctivitis
A Multi-Center, Double-Masked, Randomized, Placebl-Controlled Evaluations of teh Safety and Efficacy of SUN_131 Transdermal System (TDS) as Compated to Placebo in Patients wtih a Chalazion.
*Please Contact Kayla Riley at 605-719-3153 if you would like more information or have patients for the studies listed above.