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.

Upcoming Studies –

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.

 

Open Studies – Enrollment Open

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 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 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 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 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 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 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: 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.

 

Open Studies- Closed Enrollment

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 3, Multi-center, Randomized, Double-Masked, Active Comparator−Controlled Study To Evaluate The Efficacy And Safety Of RO6867461 In Patients With Diabetic Macular Edema (YOSEMITE)

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: 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: 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. (PANDA)

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:  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: 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 (LUCERNE)

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: 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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