At Piedmont Eye Center we are dedicated to our patients and providing the latest technology   available. To ensure technology continues to advance, we participate in many clinical trials.   Subjects are compensated for time and travel and participation is without cost to the patient. 

If you would like more information about specific studies, please fill out the form below the list of current studies.

Current Studies

AGE-RELATED MACULAR DEGENERATION (AMD)- Open Enrollment

TITLE: A Study to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) (JANSSEN)

SPONSOR: Janssen Research & Development, LLC

BRIEF SUMMARY: The purpose of this study is to evaluate change in geographic atrophy (GA) lesion growth of eyes treated with JNJ-81201887 compared to sham control.

TITLE: A Study Of The Response to Treatment After Transition to The Port Delivery System With Ranibizumab [Susvimo (Ranibizumab Injection)] In Patients With Neovascular Age-Related Macular Degeneration Previously Treated With Intravitreal Agents Other Than Ranibizumab (Belvedere)

SPONSOR: Genentech, Inc.

BRIEF SUMMARY: Study ML43000 is a Phase IV multicenter, open-label (BCVA assessor-masked) study designed to assess the response to treatment with SUSVIMO Q24W in patients with nAMD who have been previously treated with anti-VEGF agents other than ranibizumab. The substudy will evaluate the impact on corneal endothelial cells with SUSVIMO refilled every 24 weeks (Q24W) in patients with neovascular age-related macular degeneration (nAMD).

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.

DIABETES- Open Enrollment

TITLE: A Phase 2, Randomized, Multicenter Study to Assess the Dose Level of Multiple THR-149 Injections and to Evaluate the Efficacy and Safety of THR-149 Versus Aflibercept for the Treatment of Diabetic Macular Edema (DME)

SPONSOR: Oxurion

BRIEF SUMMARY: Part A of the study is conducted to select the THR-149 dose level.

Part B of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to Month 3. As from Month 3, in about half of the subjects, the effect of a single flip-over injection (aflibercept or THR-149) will be evaluated when administered 1 month after the 3 monthly injections of THR-149 or aflibercept. In the other subjects, the durability of 3 monthly injections of THR 149 or aflibercept will be evaluated.

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

Primary Purpose:  Treatment

Brief Summary:  Study BP43445 is 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 participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be up to 76 weeks

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

SPONSOR: GENENTECH, INC.

Primary Purpose:  Treatment

Brief Summary:  This Phase 4 study is designed to investigate treatment response in treatment-naïve underrepresented patients with diabetic macular edema (DME) who are treated with faricimab. The study population will consist of participants ≥18 years of age who self-identify as Black/African American, Hispanic/Latino American, or Native American/Alaska Native/Native Hawaiian or other Pacific Islander.
DRY EYE- Open Enrollment
GLAUCOMA- Open Enrollment

Title: A Phase 1/2a Study to Evaluate Safety, Tolerability, and Pharmacodynamic Effect after Single Administration of PER-001 Intravitreal Implant in Participants with Open-Angle Glaucoma (Perfuse)

Sponsor: Perfuse Therapeutics, Inc.

Brief Summary: The purpose of this research study is to see if PER-001 Intravitreal Implant is safe and tolerable. It is planned that up to 12 people with glaucoma will be in Stage 1 and approximately 24 people with glaucoma in Stage 2 of this study. An additional 30 people with glaucoma may be enrolled in Stage 2.

Title: Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients  (Study LT4032.302) 

Sponsor: Laboratories Thea

Brief Summary: The main study purpose is to demonstrate the non-inferiority of T4032 compared to Lumigan® 0.01% in terms of efficacy.

 

PRESBYOPIA- Open Enrollment

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

REFRACTIVE- Open Enrollment

Title: QAD-079 GoEyes

Sponsor: 1-800-CONTACTS

Brief Summary:  A prospective, multicenter, open label study to evaluate the reliability, validity, and safety of subjective mobile refraction assessed by GoEyes.

ATOPIC KERATOCONJUNCTIVITIS- Open Enrollment
TITLE: A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety and Tolerability of Dupilumab in Patients with Atopic Keratoconjunctivitis (AKC)
 
SPONSOR: Mark B. Abelson, MD
 
BRIEF SUMMARY: The purpose of this study is to see how safe and effective subcutaneous injections of dupilumab is compared to placebo for the treatment of the signs and symptoms of AKC.
OPEN STUDIES-CLOSED ENROLLMENT

TITLE: AGN-193408 SR in the Treatment of Open-angle Glaucoma or Ocular Hypertension

SPONSOR: AbbVie

BRIEF SUMMARY: This is a multicenter, open-label, dose escalation (Cohort 1) to masked, randomized, parallel-group (Cohort 2) study to evaluate the safety and efficacy of AGN-193408 SR in participants with open-angle glaucoma or ocular hypertension

Title: A Study Evaluating the Safety and Efficacy of AR-15512 (COMET-3)

Sponsor: Aerie Pharmaceuticals

Brief Summary: This will be a Phase 3, multicenter, vehicle-controlled, double-masked, randomized study conducted at approximately 20 sites in the United States. All subjects enrolled will have dry eye disease (DED). The study will consist of Screening (Day -14) and Baseline (Day 1) visits as well as visits at Day 7, Day 14, Day 28, and Day 90 (Study Exit)

TITLE: OTT166 in Diabetic Retinopathy (DR)

SPONSOR: OcuTerra Therapeutics, Inc

BRIEF SUMMARY: This study will evaluate the safety and efficacy of OTT166 Ophthalmic solution in participants with Diabetic Retinopathy.

TITLE: A Study of Danicopan in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

SPONSOR: Alexion Pharmaceuticals

BRIEF SUMMARY: This is a dose finding study designed to evaluate the efficacy, safety, and pharmacokinetics of danicopan in participants with GA secondary to AMD. The study consists of a Screening Period of up to 6 weeks, a 104-week masked Treatment Period, followed by a 30-day Follow-up after the last dose. This study will have 4 treatments arms: 100 milligrams (mg) twice daily (bid), 200 mg bid, 400 mg once daily (qd), and matching placebo.

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: Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD)

SPONSOR: EyePoint Pharmaceuticals, Inc

BRIEF SUMMARY: This is a phase 2 randomized, double -masked study comparing the efficacy of EYP-1901 at two dose levels: 2060 ug and 3090 ug against Aflibercept.

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: OCS-01: A Phase 3 Study Evaluating the Efficacy and Safety of OCS-01 Eyedrops Compared to Vehicle for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

SPONSOR: Oculis

BRIEF SUMMARY: The purpose of this study is to evaluate the efficacy and safety of OCS-01 Ophthalmic Suspension versus placebo (vehicle) in the treatment of inflammation and pain following cataract surgery.

TITLE: A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema (Rhone-X)

SPONSOR: Hoffmann-La Roche

BRIEF SUMMARY: This is a multicenter long-term extension study designed to evaluate the long-term safety and tolerability of faricimab administered by intravitreal (IVT) injection at a personalized treatment interval (PTI) to participants who enrolled in and completed one of the two Phase III studies, GR40349 (NCT03622580) or GR40398 (NCT03622593), also referred to as the parent studies.

TITLE:  A Pivotal, Double-Masked, Randomized, 2-stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema (Oculis)

SPONSOR: OCULIS

BRIEF SUMMARY:  The purpose of this study is to evaluate the efficacy and safety of OCS-01 ophthalmic suspension versus vehicle alone in subjects with DME.

Title: A Long-Term Safety Study Evaluating the Safety and Systemic Exposure of AR-15512 (COMET-4)

Sponsor: Aerie Pharmaceuticals

Brief Summary: This will be a 12-month, multicenter, vehicle-controlled, double-masked, randomized Phase 3 study conducted at approximately 10 sites in the United States. All subjects enrolled will have dry eye disease (DED). The study will consist of a Baseline (Day 1) visit as well as visits at Day 14, Day 90, Day 180, Day 270, and Day 365 (Study Exit).

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: 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 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:  (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.