Clinical Research Studies:
At Piedmont Eye Center we are dedicated to our patients and providing the latest technology available. To do our part to ensure technology continues to advance, we are enrolled in multiple clinical trials. If you would like more information about enrolling in one of our studies that apply to you, please contact our Research Coordinators, Susan Shelton (ext. 574), Michelle Wells (ext. 575) or Jennifer Frederick (ext.543) at 434.947.3984. They will be happy to answer your questions.
Title: A Phase 1/2 Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of an Intravitreal Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Neovascular Age-related Macular Degeneration
Sponsor: Graybug Vision
Purpose: In this 2-part study, Part 1 is a multicenter, open-label, safety, tolerability, and systemic exposure evaluation to Sunitinib in escalating doses of a single IVT injection of GB-102, while Part 2 is a multicenter, double-masked, randomized (1:1:1), parallel‑group, safety, and efficacy evaluation of repeated IVT injections of 2 dose levels of GB‑102 compared with aflibercept.
Open Studies – Enrollment Open
Title: A Phase 3, Multi-Center, Randomized, Double Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of SkQ1 Ophthalmic Solution in the Environment and During Challenge in the Controlled Adverse Environmental Model for the Treatment of Dry Eye Syndrome
Sponsor: Mitotech, SA
Purpose: The objective of this study is to compare the safety and efficacy of SkQ1 ophthalmic solution to placebo for the treatment of the signs and symptoms of dry eye syndrome.
Sponsor: Oyster Point Pharma, Inc.
Purpose: The objective of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray as compared to placebo on signs and symptoms of dry eye disease.
Sponsor: ReGenTree, LLC
Purpose: The objective of this study is to compare the safety and efficacy of 0.1% RGN-259 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.
Title: A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, ACTIVE COMPARATOR CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FARICIMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION
Sponsor: F. Hoffmann-La Roche Ltd
Purpose: This is a Phase III, multicenter, randomized, active comparator controlled, double-masked, parallel-group, 112-week study to investigate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at up to 16-week intervals to treatment-naïve patients with nAMD.
Sponsor: GLAUKOS CORPORATION
Purpose: To compare the safety and initial efficacy of intraocular implants containing travoprost at two different elution rates versus Timolol Maleate Ophthalmic Solution, USP, 0.5% (timolol) in reducing elevated intraocular pressure in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Sponsor: F. Hoffmann-La Roche Ltd
Purpose: This study will evaluate the efficacy, safety, pharmacokinetics, and optimal treatment frequency of RO6867461 compared with aflibercept (Eylea®) monotherapy in patients with diabetic macular edema (DME). Specific objectives and corresponding endpoints for the study are outlined in the following table.
Title: Multi-Center, Double-Masked, Randomized, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Conbercept Intravitreal Injection in Subjects with Neovascular Age-Related Macular Degeneration.
Sponsor: Chengdu Kanghong Biotechnology Co., Ltd.
Purpose: The purpose of this clinical study is to evaluate the efficacy and safety of 0.5 mg and 1.0 mg conbercept IVT injection compared with the vascular endothelial growth factor (VEGF) antagonist active control, aflibercept IVT injection (2.0 mg, Eylea®, Regeneron Pharmaceuticals, Inc.), in subjects with neovascular age-related macular degeneration (AMD).
Purpose: This study will evaluate the intraocular pressure-lowering effect and safety of Bimatoprost SR compared with selective laser trabeculoplasty in patients with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication.
Open Studies- Closed Enrollment
Title: A CLINICAL COMPARISON OF TWO MARKETED EYE DROP PRODUCTS FOR THE REDUCTION OF OCULAR HYPEREMIA
Sponsor: Prestige Consumer Healthcare, Inc.
Purpose: To compare the results of two marketed eye drops for the reduction of red eyes.
Purpose: A phase 3 study to evaluate the efficacy and safety of bimatoprost sustained-release (SR) in patients with open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period with an 8-month extended follow-up.
Purpose: Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration
Title: A MULTI-CENTER, RANDOMIZED, DOUBLE-MASKED, ACTIVE CONTROLLED, PARALLEL GROUP BIOEQUIVALENCE STUDY WITH CLINICAL ENDPOINT COMPARING BRINZOLAMIDE OPHTHALMIC SUSPENSION 1% of PERRIGO PHARMA INTERNATIONAL DAC to AZOPT® (BRINZOLAMIDE OPHTHALMIC SUSPENSION) 1% OF NOVARTIS PHARMACEUTICALS CORPORATION IN THE TREATMENT OF PRIMARY OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION IN BOTH EYES.
Purpose: The objective of the study is to demonstrate bioequivalence of brinzolamide ophthalmic suspension 1% (Perrigo Pharma International DAC) to Azopt® (brinzolamide ophthalmic suspension) 1% (Novartis Pharmaceutical Corporation) by comparing their efficacy and safety in the treatment of subjects with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OH) in both eyes.