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.

 

Open Studies – Enrollment Open

Title: A PHASE III, MULTICENTER, RANDOMIZED STUDY OF THE EFFICACY, SAFETY, AND  PHARMACOKINETICS OF THE PORT DELIVERY SYSTEM WITH RANIBIZUMAB IN PATIENTS WITH DIABETIC RETINOPATHY (PAVILION)

 Sponsor: F. Hoffman-La Roche Ltd.

Purpose: To evaluate the efficacy, safety, and pharmacokinetics of Ranibizumab delivered via the Port Delivery System in patients with Diabetic Retinopathy.

Title: A Multi-Center, Double-Masked, Vehicle-Controlled, Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia

Sponsor: Orasis Pharmaceuticals Ltd.

Purpose: To evaluate the efficacy of CSF-1 for the temporary correction of presbyopia.

Title: A Phase 3b Study to Evaluate the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension

Sponsor: AbbVie ( formerly Allergan)

Purpose: This study evaluates the duration of intraocular pressure (IOP)-lowering effect and safety of as needed administrations of Bimatoprost sustained release (SR) in participants with open-angle glaucoma (OAG) or ocular hypertension (OHT) who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy.

Title: A Multi-Center, Double-Masked, Randomized, Two-Arm, Parallel-Group, Safety and Efficacy Study to Compare Perrigo Pharmaceuticals International DAC Brinzolamide and Brimonidine Tartrate Ophthalmic Suspension to Novartis Pharmaceuticals Simbrinza® in the Treatment of Chronic Open Angle Glaucoma or Ocular Hypertension in both Eyes

Sponsor: Perrigo Pharmaceuticals

Purpose: To compare the safety and efficacy profiles of Perrigo Pharmaceuticals International DAC Brinzolamide and Brimonidine Tartrate Ophthalmic Suspension to Novartis Pharmaceuticals Simbrinza® in order to prove bioequivalence between them in the treatment of chronic open angle glaucoma or ocular hypertension in both eyes.

Title: Phase 2, Multicenter, Randomized, Controlled, Double-Masked, Clinical Trial to Evaluate the Efficacy and Safety of OC-01 Nasal Spray in Subjects with Neurotrophic Keratopathy (the Olympia Study)

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 nasal spray for complete resolution of corneal staining in subjects with Stage 1 (corneal epithelial hyperplasia/punctate keratopathy) neurotrophic keratopathy (NK) in one or both eyes.

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.

Title:  GR40550 (PAGODA) – A Phase III, Multicenter, Randomized, Visual Assessor-Masked, Active-Comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System with Ranibizumab in Patients with Diabetic Macular Edema.

Sponsor: F. Hoffman-La Roche Ltd.

Purpose: Evaluate the efficacy, safety, and pharmacokinetics of the Port Delivery System with Ranibizumab in patients with Diabetic Macular Edema (DME).

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.

Title: A Phase 3, Multicenter, Randomized, Controlled, Double Masked, Clinical Trial to Evaluate the Efficacy and Safety of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease

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.

Title: A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of RGN-259 Ophthalmic Solutions for the Treatment of Dry Eye (ARISE-3)

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.

Title: PROSPECTIVE, RANDOMIZED PHASE 3 STUDY COMPARING TWO MODELS OF A TRAVOPROST INTRAOCULAR IMPLANT TO TIMOLOL MALEATE OPHTHALMIC SOLUTION, USP, 0.5%

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).

Title: A Phase 3, Multi-center, Randomized, Double-Masked, Active Comparator−Controlled Study To Evaluate The Efficacy And Safety Of RO6867461 In Patients With Diabetic Macular Edema

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).

Title: Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension

Sponsor: Allergan

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: PROSPECTIVE, RANDOMIZED PHASE 3 STUDY COMPARING TWO MODELS OF A TRAVOPROST INTRAOCULAR IMPLANT TO TIMOLOL MALEATE OPHTHALMIC SOLUTION, USP, 0.5%

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).

Title: Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension

Sponsor: Allergan

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.

 

What Our Patients Think

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