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 II, Multicenter, Randomized, Double Masked, Active Comparator-Controlled Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7200220 Administered Intravitreally in Patients With Diabetic Macular Edema (Alluvium)

SPONSOR: HOFFMAN-LA Roche

Objective:  Treatment

TITLE:  A Study to Investigate Faricimab Treatment Response in Treatment-Naive, Underrepresented Patients With Diabetic Macular Edema (ELEVATUM)

SPONSOR: GENENTECH, INC.

Objective:  Treatment

TITLE:  A Prospective, Randomized, Double-masked, Sham-controlled, Multicenter, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy (NPDR)

SPONSOR:  Kodiac Sciences, Inc.

Objective:  A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy (NPDR)

Title: Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia – Full Text View – ClinicalTrials.gov

Sponsor: Visus Therapeutics

Purpose: Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF Topical Ophthalmic Solution With Emmetropic Phakic and Pseudophakic Presbyopia

TITLE: A Phase 3, Multicentre, Double-Masked, Randomised Study To Evaluate The Efficacy And Safety Of Intravitreal OPT_302 In Combination With Ranibizumab, Compared With Ranibizumab Alone, In Participants With Neovascular Age-Related Macular Degeneration (nAMD) (Shore)

SPONSOR:  OPTHEA LTD.

Objective:  To determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular AMD.

Title: A Phase 2, Randomized, Placebo-Controlled, Double-Masked Study To Access Safety And Efficacy Of Multiple Doses Of Ionis-fb-lrx, an Antisense Inhibitor Of Complement Factor b, In Patients With Geographic Atrophy Secondary To Age-Related Macular Degeneration (AMD) (Golden)

SPONSOR:  IONIS

Objective:  To evaluate the effect of ISIS 696844 on the rate of change of the area of GA secondary to AMD measured by fundus autofluorescence (FAF) Secondary Objectives To evaluate the effect of ISIS 696844 on plasma FB levels and serum AH50 activity in AMD patients To assess the effect of ISIS 696844 to slow reduction of low luminance visual acuity (LLVA).

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: 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 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.

 

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.

Title: A Multicenter, Open-Label Extension Study To Evaluate The Long-Term Safety And Tolerability Of Faricimab In Patients With Diabetic Macular Edema (Rhone-X)

SPONSOR: F. HOFFMANN-LA ROCHE LTD

Objective:  This long-term extension (LTE) study will evaluate the long-term safety, tolerability, and efficacy of intravitreal (IVT) faricimab in patients with diabetic macular edema who have completed either of the Phase III (GR40349 or GR40398) studies. Additional assessments relating to pharmacokinetics, immunogenicity, and biomarkers will be performed.

Title:  A Multicenter, Open-Label Extension Study To Evaluate The Long-Term Safety And Tolerability Of Faricimab In Patients With Neovascular Age-Related Macular Degeneration (Avonelle-X)

SPONSOR: F. HOFFMANN-LA ROCHE LTD

Objective:  This study will evaluate the long-term safety and tolerability of intravitreal (IVT) faricimab in patients with neovascular age-related macular degeneration (nAMD) who have completed either of the Phase III (GR40306 or GR40844) studies. Additional assessments relating to efficacy, pharmacokinetics, immunogenicity, and biomarkers will be performed.

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 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. (GR40550 PAGODA)

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: 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.

Title:  A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study To Evaluate The Efficacy And Safety Of Faricimab In Patients With Macular Edema Secondary To Branch Retinal Vein Occlusion (Balaton)

SPONSOR: F. HOFFMANN-LA ROCHE LTD

Objective:  Objective:  This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab compared with aflibercept in patients with macular edema due to branch retinal vein occlusion (BRVO) up to the primary endpoint at Week 24. Efficacy, safety, and pharmacokinetics of faricimab administered according to the personalized treatment interval (PTI) dosing regimen (i.e., from every 4 weeks [Q4W] to every 16 weeks [Q16W]) will be assessed during the study period from Weeks 24 to 72.

Title:  A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study To Evaluate The Efficacy And Safety Of Faricimab In Patients With Macular Edema Secondary To Central Retinal Or Hemi Retinal Vein Occlusion (Comino)

SPONSOR: F. HOFFMANN-LA ROCHE LTD

Objective:  This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab compared with aflibercept in patients with macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO) up to the primary endpoint at Week 24. Efficacy, safety, and pharmacokinetics of faricimab administered according to the personalized treatment interval (PTI) dosing regimen (i.e., from every 4 weeks [Q4W] to every 16 weeks [Q16W]) will be assessed during the study period from Weeks 24 to 72.

Title:  A 52-Week Multicenter, Randomized, Double-Masked, 2-Arm Parallel Study To Compare Efficacy, Safety and Immunogenicity Of SOK583A To Eylea®, Administered Intravitreally, In Patients With Neovascular Age-Related Macular Degeneration (MyLight)

SPONSOR: SANDOZ

Objective:  To demonstrate similar efficacy, safety and immunogenicity of SOK583A1 and Eylea as per Eylea approved treatment regimen in patients with nAMD.

Title:   A Longitudinal, Biomarker Study Of Anti-VEGF, to Explore the Relationship Between Aqueous Humor Composition And Multimodal Retinal Imaging In Neovascular Age-Related Macular Degeneration And Diabetic Macular Edema (Longitude)

SPONSOR:  F. HOFFMANN-LA ROCHE LTD

Objective:  This is an open-label, multicenter, non-randomized, two-cohort, biomarker study in treatment-naïve study eyes of 100 nAMD participants and treatment-naïve study eyes of 100 DME participants to explore the composition of AH and features of multimodal retinal imaging before and during a six-month treatment period with aflibercept.

Title:  A Phase IIIb, Multicenter, Open-Label, Single-Arm Study Of The Efficacy And Safety Of The Port Delivery System With Ranibizumab In Patients With Neovascular Age-Related Macular Degeneration Previously Treated With Intravitreal Agents Other Than Ranibizumab (Belvedere)

SPONSOR:  GENENTECH, INC

Objective:  This study will evaluate the efficacy and safety of the Port Delivery System with ranibizumab (PDS) 100 mg/mL delivered every 24 weeks (Q24W) in patients with neovascular age-related macular degeneration (nAMD) previously treated with anti-VGEF agents other that Ranibizumab.

TITLE:  (Gleam)  A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Visual Impairment Secondary to Treatment-naïve Diabetic Macular Edema (DME)

SPONSOR:  Kodiac Sciences, Inc.

Objective:  This is a Phase 3, prospective, randomized, double-masked, two-arm, multi-center non-inferiority study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with treatment-naïve DME.  The primary endpoint will be assessed at Year 1; additional secondary endpoints for efficacy will be assessed at Years 1 and 2.

TITLE:  A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) (Daylight)

SPONSOR:  Kodiac Sciences, Inc.

Purpose:  This is a Phase 3, prospective, randomized, double-masked, two-arm, multi-center non-inferiority study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with visual impairment due to treatment-naïve neovascular (wet) age-related macular degeneration (wAMD). The primary endpoint will be assessed at Week 40; additional secondary endpoints for efficacy will be assessed by visit over time.

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