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Clinical Research

Clinical Research

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.

Eye Institute Trials

Dr. Prema Abraham

Currently Enrolling Studies

KalVista Diabetic Macular Edema– A randomized sham-controlled double-masked Phase 2a study of the efficacy, safety and tolerability of the intravitreal plasma kallikrein inhibitor, KVD001, in subjects with center-involving diabetic macular edema (ciDME) who have had prior anti-vascular endothelial growth factor (VEGF) treatment (6 months)

Clearside Topaz Retinal Vein Occlusion– 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)

Allergan Maple Wet AMD– A multicenter, open-label, single-arm study to evaluate abicipar for safety and treatment effect in patients with neovascular age-related macular degeneration (AMD). (28-week trial)

Samsung Bioepsis -A Phase 3 randomized, Double-masked, parallel group, multicenter study to compare the efficacy, safety, pharmacokinetics and immunogenicity between SB11 (proposed ranibizumab biosimilar) and Lucentis® in Subjects with Neovascular Age-related Macular Degeneration (1-Year trial)

Open in August

Chengdu Wet AMD – A multicenter, double-masked, randomized, dose-ranging trial to evaluate the efficacy and safety of Conbercept Intravitreal Injection in Subjects with Neovascular Age-related macular degeneration. (2-year trial)

Apellis Phase 3 Derby Study Geographic Atrophy -A Phase 3, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy with Sham Injections in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (2-year study)

Upcoming

Santen Wet AMD- A multicenter, randomized, double masked and active controlled Phase 2 study assessing the efficacy and safety of intravitreal injections of DE-122 in combination with Lucentis compared to Lucentis monotherapy in subjects with wet age-related macular degeneration-(6 month trial)

*Please Contact Leah Callahan at 719-3320 if you would like more information or have patients for any of the studies listed above for Dr. Abraham.

 


Dr. Terrence Spencer, Dr. Spencer Khachikian & Dr. Adam Jorgensen

Upcoming

Cataract Trial

PI; Khachikian  SUBI: Spencer & Jorgensen – A Phase ½ Dose-Ranging, Open-Label, Randomized, Clinical Study to Assess the Efficacy and Safety of SED80 for the treatment of inflammation Associated with Cataract Surgery

PI: Spencer SUBI: Khachikian & Jorgensen – A Phase 3, Randomized, Multicenter, Double-Masked Study to Compare the Ocular Safety, Tolerability, and Efficacy of ISV-305 (031% Dexamethasone in DuarSite 2) to SuraSite 2 Vehicle for the treatment of Inflammation and Pain Associated with Cataract Surgery.

 

Dry Eye Trial

PI: Spencer SUBI: Khachikian – A PHASE 3, DOUBLE0MASKED, RANDOMIZED,CONTROLLED STUDY OF KPI-121 0.25% OPHTHALMIC SUSPENSION COMPARED TO VEHICLE INSUBJECTS WITH DRY EYE DISEASE (STRIDE 3)

PI: Khachikian SUB: Spencer – A Double-Masked, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of SJP-0035 0.001% for the Treatment of Patients with Dry Eye Disease (DELTA-1 Study)

 

Glaucoma Trial

PI:Jorgensen SUBI: Spencer & Khachikian -A Phase III, Randomized Double-Masked, Active-Controlled, Parallel-Group, Multi-center Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution 0.002% Compared with Timolol Maleate Ophthalmic Solution 0.5% in Subjects with Glaucoma or Ocular Hypertension – Spectrum 3 Study

*Please Contact Kayla Riley at 605-719-3153 if you would like more information or have patients for the studies listed above for doctors Spencer, Khachikian or Jorgensen.

 

Where We Are

2800 3rd St.
Rapid City, SD 57701
605-341-2000