Clinical Trials

Cornea & External Diseases

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General Opththalmology / Genetics

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Glaucoma Service

A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Performance of the AqueSys Microfistula Implant in Subjects With Refractory Glaucoma

Condition(s) Being Treated: Refractory Glaucoma
Sponsor: Aquesys
Study Short Title: AqueSys Microfistula Implant in Refractory Glaucoma
Study Summary:
To establish the safety and performance of the AqueSys Microfistula Implant in eyes with refractory glaucoma.
Study Status: Closed
Investigator(s): Alena Reznik, MD
ClinicalTrials.gov Information NCT01640756

 

Uvetis & Ocular inflammation

A Randomized, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Active Non-infectious IntermeDiate, Posterior, or Pan- Uveitis

Condition(s) Being Treated: Non-Infectious Uveitis
Sponsor: XOMA
Study Short Title: EyeGuard A
Study Summary:
The purpose of this study is to evaluate the efficacy of gevokizumab in the treatment of active non-infectious intermediate, posterior, or pan- uveitis.
Study Status: Closed
Investigator(s): Damien C. Rodger, MD, PhD
ClinicalTrials.gov Information: NCT01684345

A Randomized, Double-Masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Controlled Non-infectious IntermeDiate, Posterior, or Pan- Uveitis

Condition(s) Being Treated: Non-Infectious Uveitis
Sponsor: XOMA
Study Short Title: EyeGuard C
Study Summary:
The purpose of this study is to evaluate the efficacy of gevokizumab in reducing the risk of recurrent uveitic disease in subjects with non-infectious uveitis whose disease is currently controlled with systemic treatment.
Study Status: Closed
Investigator(s): Damien C. Rodger, MD, PhD
ClinicalTrials.gov Information: NCT01747538

 

Vitreoretinal Surgery & Retinal Disease

Clinical Study to Investigate Safety and Efficacy of GSK933776 in Adult Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration

Condition(s) Being Treated: Geographic Atrophy (GA) Secondary and Age-related Macular Degeneration (AMD)
Sponsor: GlaxoSmithKline (GSK)
Study Short Title: BAM
Study Summary:
The purpose of this study is to determine the safety and efficacy of GSK933776 in the treatment of geographic atrophy secondary to age-related macular degeneration.
Study Status: Closed
Investigator(s): Lisa C. Olmos de Koo, MD, MBA
ClinicalTrials.gov Information NCT01342926

Data Collection Study of the Nidek Optical Coherence Tomography RS-3000 for 3D Measurements of the Eye

Condition(s) Being Treated: Ocular Physiology
Sponsor: Nidek Co., LTD.
Study Short Title: OCT RS-3000
Study Summary:
The purpose of this clinical study is to collect and evaluate the data from eye scans using an investigational three-dimensional eye imaging photography device called the Nidek Optical Coherence Tomography (OCT) RS-3000. OCT stands for Optical Coherence Tomography, a technique that uses invisible wavelengths of light to make detailed images of the tissues at the back of the eye. These images provide information that physicians may use to help diagnose eye conditions and/or to monitor changes in the eye during treatment.
Study Status: Closed
Investigator(s): Lisa C. Olmos de Koo, MD, MBA
ClinicalTrials.gov Information NCT01663688

Topcon 3D OCT-1 Maestro and 3D OCT-2000 Optical Coherence Tomography Systems: Reference Database Study

Condition(s) Being Treated: N/A (Healthy Eyes)
Sponsor: Topcon Medical Systems, Inc.
Study Short Title: OCT Reference Database
Study Summary:
The purpose of this study is to collect OCT measurement data on normal healthy eyes in order to determine the reference limits for Topcon 3D OCT-1 Maestro and for Topcon 3D OCT-2000 based on the percentile points for 1%,5%, 95%, and 99%.
Study Status: Closed
Investigator(s): Lisa C. Olmos de Koo, MD, MBA
ClinicalTrials.gov Information NCT01986478

Ocriplasmin Research to Better Inform Treatment (ORBIT)

Condition(s) Being Treated: Symptomatic Vitreomacular Adhesion
Sponsor: ThromboGenics
Study Short Title: ORBIT
Study Summary:
This is a multicenter, prospective, observational, Phase 4 study that will assess clinical outcomes and safety of JETREA® administered in a real-world setting for the treatment of symptomatic vitreomacular adhesion (VMA) by assessing anatomical and functional outcomes in 1500 patients recruited across approximately 120 USA retina sites.
Study Status: Closed
Investigator(s): Lisa C. Olmos de Koo, MD, MBA
ClinicalTrials.gov Information NCT02079883

 

Cornea & External Diseases

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General Opththalmology / Genetics

Human Connectomes for Low Vision, Blindness, and Sight Restoration

Condition(s) Being Treated: Low Vision, Blindness
Sponsor: National Eye Institute
Study Short Title: Human Connectome Project
Study Summary:
The brain mapping research will provide a baseline that in turn allows a more comprehensive understanding of conditions that affect the retina and the downstream consequences in the central visual pathways and with this knowledge, we can better treat visual impairments.
Study Status: Enrolling
Investigator(s): James D. Weiland, PhD, Hossein Ameri, MD, PhD, Amir Kashani, MD, PhD, Andrew A. Moshfeghi, MD, MBA, Vivek R. Patel, MD

 

Glaucoma Service

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Uveitis & Ocular Inflammation

PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial (POINT)

Condition(s) Being Treated: Macular Edema, Uveitis
Sponsor: Johns Hopkins University/National Eye Institute
Study Short Title: POINT
Study Summary:
To evaluate the relative efficacy of three commonly utilized regional corticosteroids for the regional treatment of uveitic macular edema: periocular triamcinolone acetonide; intravitreal triamcinolone acetonide; intravitreal dexamethasone implant. The primary efficacy measure will be percent change in central subfield thickness as measured by OCT at 8 weeks. Participants will continue in the study for 24 weeks in order to evaluate relative effects of the 3 treatment strategies on the duration of treatment effects, requirement for additional injections, and adverse effects.
Study Status: Enrolling
Investigator(s): Damien C. Rodger, MD, PhD
ClinicalTrials.gov Information NCT02374060

Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Non-Infectious Anterior Uveitis (EGP-437-006)

Condition(s) Being Treated: Anterior Uveitis
Sponsor: EyeGate Pharmaceuticals, Inc.
Study Short Title: EyeGate (EGP-437-006)
Study Summary:
The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery System (EGDS) compared to prednisolone acetate ophthalmic suspension (1%) in patients with non-infectious anterior segment uveitis.
Study Status: Enrolling
Investigator(s): Damien C. Rodger, MD, PhD
ClinicalTrials.gov Information NCT02517619

 

Vitreoretinal Surgery & Retinal Disease

New Enrollment Post-Approval Study of the Argus II Retinal Prosthesis System

Condition(s) Being Treated: Severe to Profound Retinitis Pigmentosa
Sponsor: Second Sight, Inc.
Study Short Title: ARGUS II Post-Approval Study
Study Summary:
This post-approval study is being implemented to monitor the use of Argus II System in a larger US population than available within pre-approval studies. An attempt will be made to include all eligible and willing subjects implanted with Argus II System in the United States. Safety data will be monitored to ensure continued acceptability of risks to study subjects. The utility (i.e. visual function and functional vision) and reliability of Argus II System will also be evaluated.
Study Status: Enrolling
Investigator(s): Hossein Ameri, MD, PhD
ClinicalTrials.gov Information NCT01860092

A Phase I/IIa Safety Study of Subretinal Implantation of CPCB-RPE1 (Human Embryonic Stem Cell-Derived Retinal Pigment Epithelial Cells Seeded on a Polymeric Substrate) in Subjects With Advanced, Dry Age-Related Macular Degeneration (AMD)

Condition(s) Being Treated: Age-Related Macular Degeneration (AMD)
Sponsor: Regenerative Patch Technologies, LLC
Study Short Title: Study of Subretinal Implantation of Human Embryonic Stem Cell-Derived RPE Cells in Advanced Dry AMD
Study Summary:
This is a Phase I/IIa clinical trial designed to be the first-in-human assessment of the feasibility of delivery and safety of CPCB-RPE1 (Human Embryonic Stem Cell-Derived Retinal Pigment Epithelial (RPE) Cells Seeded on a Polymeric Substrate) in patients with advanced, dry age-related macular degeneration. The objectives are to test the safety and tolerability of CPCB-RPE1 and to assess visual acuity, visual field as well as retinal function after implantation. Exploratory objectives include the assessment of geographic atrophy over time and changes in contrast sensitivity.
Study Status: Enrolling
Investigator(s): Amir H. Kashani, MD, PhD
ClinicalTrials.gov Information NCT02590692

A Safety and Efficacy Study of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration (CEDAR)

Condition(s) Being Treated: Neovascular Age-Related Macular Degeneration
Sponsor: Allergan
Study Short Title: CEDR
Study Summary:
This is a safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration.
Study Status: Enrolling
Investigator(s): Amir H. Kashani, MD, PhD
ClinicalTrials.gov Information NCT02462928

 

Cornea & External Diseases

Effect of Corneal Preservation Time on Long-Term Graft Success Cornea Preservation Time Study

Condition(s) Being Treated: Corneal Transplantation Patients
Sponsor: Jaeb Center for Health Research/National Eye Institute
Study Short Title: CPTS
Study Summary:
Examines the impact of preservation time on graft failure and endothelial cell density following endothelial keratoplasty (EK)
Study Status: Enrollment Closed (Follow-Up)
Investigator(s): Jonathan C. Song, MD
ClinicalTrials.gov Information: NCT01537393

 

General Opththalmology / Genetics

Please Contact Us At 323-745-2223 For More Information On This Trial

 

Glaucoma Service

Please Contact Us At 323-745-2223 For More Information On This Trial

 

Uvetis & Ocular inflammation

Long-term Follow-up of Patients Who Participated in the Multicenter Uveitis Steroid Treatment Trials (MUST Trial Follow-up Study)

Condition(s) Being Treated: Non-Infectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis
Sponsor: Johns Hopkins University/National Eye Institute
Study Short Title: MUST-FS
Study Summary:
A multicenter, randomized controlled clinical trial, that will compare the fluocinolone acetonide implant to standard systemic therapy for the treatment of patients with non-infectious intermediate uveitis, posterior uveitis, or panuveitis.
Study Status: Enrollment Closed (Follow-up)
Investigator(s): Damien C. Rodger, MD, PhD
ClinicalTrials.gov Information: NCT00132691

 

Vitreoretinal Surgery & Retinal Disease

Argus II Retinal Stimulation System Feasibility Protocol

Condition(s) Being Treated: Retinitis Pigmentosa
Sponsor: Second Sight
Study Short Title: Argus II Follow-Up Study
Study Summary: Argus II Follow-Up Study
Study Status: Enrollment Closed (Follow-Up)
Investigator(s): Hossein Ameri, MD, PhD
ClinicalTrials.gov Information: NCT00407602

Study of of APL-2 Therapy in Patients Geographic Atrophy (FILLY)

Condition(s) Being Treated: Geographic Atrophy
Sponsor: Apellis Pharmaceuticals, Inc.
Study Short Title: FILLY
Study Summary:
The primary objectives of the study are to assess the safety, tolerability and evidence of activity of multiple intravitreal (IVT) injections of APL-2 in subjects with Geographic Atrophy associated with Age-Related Macular Degeneration (AMD).
Study Status: Enrollment Closed
Investigator(s): Linda A. Lam, MD, MBA
ClinicalTrials.gov Information: NCT02503332

National Ophthalmic Genotyping and Phenotyping Network, Stage 1 – Creation of DNA Repository for Inherited Ophthalmic Diseases

Condition(s) Being Treated: Retinitis Pigmentosa, Inherited Ophthalmic Diseases
Sponsor: National Eye Institute
Study Short Title: eyeGENE
Study Summary:
The National Ophthalmic Genotyping Network (eyeGENE ) is creating a national tissue repository to further advance genetic research on inherited eye disease, while at the same time providing clinically-useful information back to patients and physicians who request it.. Physicians in collaborating institutions will recruit patients to participate in the study. Patients will provide a blood sample and undergo a standard eye examination. The blood sample and clinical information will then be sent to the NEI for testing, processing and storing in the tissue repository. Patients are given the option to receive results back and/or to be re-contacted in the event of future clinical studies. Information supplied to the testing laboratories includes a unique identification number, the patient gender, and the patient date of birth. The stored samples will be made available to researchers along with information about the patient’s disease, but without patient identifiers.
Study Status: Enrollment Closed
Investigator(s): Hossein Ameri, MD, PhD
ClinicalTrials.gov Information: NCT00378742