Clinical Trials

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: Closed
Investigator(s): Jonathan C. Song, MD, MBA
ClinicalTrials.gov Information: NCT01537393

 

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

 

Neuro-Ophthalmology

Please Contact Us At 323-442-6335 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: Closed
Investigator(s): Damien C. Rodger, MD, PhD
ClinicalTrials.gov Information: NCT00132691

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: Closed
Investigator(s): Damien C. Rodger, MD, PhD
ClinicalTrials.gov Information NCT02374060

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

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

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

A Randomized, Double-Masked, Active-Controlled Phase 2 Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal REGN910-3 in Patients With Neovascular Age-Related Macular Degeneration

Condition(s) Being Treated: Neovascular Age-Related Macular Degeneration
Sponsor: Regeneron Pharmaceuticals
Study Summary:
The primary objective of the study is to compare the efficacy of intravitreal (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI).
Study Status: Enrollment Closed
Investigator(s): Andrew A. Moshfeghi, MD, MBA
ClinicalTrials.gov Information: NCT02713204

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: CEDAR
Study Summary:
This is a safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration.
Study Status: Enrollment Closed
Investigator(s): Amir H. Kashani, MD, PhD
ClinicalTrials.gov Information: NCT02462928

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

 

Cornea & External Diseases

A Phase 3, Multi-Center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to Placebo in the Treatment of ADENOVIRAL Conjunctivitis.

Condition(s) Being Treated: Adenoviral Conjunctivitis
Sponsor: Shire
Study Short Title: Treatment of Adenoviral Conjunctivitis with SHP640 compared to placebo
Study Summary:
The purpose of this study is to determine if an investigational treatment is effective compared with placebo in the treatment of adults and children with adenoviral conjunctivitis.
Study Status: Enrolling
Investigator(s): Charles Flowers, MD
ClinicalTrials.gov Information NCT02998554

A Phase 3, Multi-Center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to Placebo in the Treatment of BACTERIAL Conjunctivitis.

Condition(s) Being Treated: Bacterial Conjunctivitis
Sponsor: Shire
Study Short Title: Treatment of Bacterial Conjunctivitis with SHP640 compared to PVP-Iodine and placebo
Study Summary:
The purpose of this study is to determine if an investigational treatment is effective compared with placebo in the treatment of adults and children with bacterial conjunctivitis.
Study Status: Enrolling
Investigator(s): Charles Flowers, MD
ClinicalTrials.gov Information NCT03004924

 

Glaucoma Service

The AGS Second Aqueous Shunt Implant vs. Trans-Scleral Cyclophotocoagulation Treatment Study (ASSISTS)

Condition(s) Being Treated: Glaucoma
Sponsor: University of Texas Health Science Center and the American Glaucoma Society
Study Summary:
The purpose of this study is to compare two different eye surgeries (second aqueous shunt vs. laser) in patients who have uncontrolled glaucoma after an aqueous shunt implant.
Study Status: Enrolling
Investigator(s): Alena Reznik, MD
ClinicalTrials.gov Information: Not available

A Prospective, Double-Masked, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Study Assessing the Safety and Ocular Hypotensive Efficacy of Optimum Concentration to be Used Clinically of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects with Open-Angle Glaucoma of Ocular Hypertension in the United States

Condition(s) Being Treated: Elevated intraocular pressure (IOP) in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Sponsor: Aerie Pharmaceuticals, Inc.
Short Study Title: Study of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects with Open-Angle Glaucoma or Ocular Hypertension.
Study Summary:
To test the safety and effectiveness of netarsudil 0.02% and 0.04% ophthalmic solution relative to placebo in Japanese/Japanese-American subjects with elevated intraocular pressure.
Study Status: Enrolling
Investigator(s): Alena Reznik, MD
ClinicalTrials.gov Information NCT03310580

 

Neuro-Ophthalmology

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): Hossein Ameri, MD, PhD, Amir Kashani, MD, PhD, Andrew A. Moshfeghi, MD, MBA, Vivek R. Patel, MD

A Multicenter, Partially-Masked, Randomized, Controlled Study of Medical Treatment vs. Medical Therapy plus Optic Nerve Sheath Fenestration vs. Medical Therapy plus Stereotactic Ventriculoperitoneal Cerebrospinal Fluid Shunting in Subjects with Idiopathic Intracranial Hypertension and Moderate to Severe Visual Loss.

Condition(s) Being Treated: Idiopathic Intracranial Hypertension
Sponsor: Jaeb Center for Health Research
Study Short Title: Surgical Idiopathic Intracranial Hypertension Treatment Trial (“SIGHT”)
Study Summary:
Randomized trial of adults (> 18 years old) with idiopathic intracranial hypertension and moderate to severe visual loss without substantial recent treatment who are randomly assigned to (1) medical therapy, (2) medical therapy plus ONSF, or (3) medical therapy plus VPS. The primary outcome is visual field mean deviation change at first of Month 6 (26 weeks) or time of treatment failure of the eligible eye(s), followed by a continuation study to assess time to treatment failure. The determination of eligible eye(s) is based on meeting the eligibility criteria at baseline.
Study Status: Not Yet Enrolling
Investigator(s): Vivek Patel, MD
ClinicalTrials.gov Information: NCT03501966

Phase 2/3, Randomized, Double-Masked, Sham Controlled Trial of QPI-1007 in Subjects with Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

Condition(s) Being Treated: Nonarteric Anterior Ischemic Optic Neuropathy
Sponsor: Quark Pharmaceuticals
Study Summary:
This study will determine the effect of QPI-1007 on visual function in subjects with recent-onset NAION and assess the safety and tolerability of intravitreal injections of QPI-1007 in this population. This study will also evaluate the structural changes in the retina following administration of QPI-1007.
Study Status: Enrolling
Investigator(s): Vivek Patel, MD
ClinicalTrials.gov Information: NCT02341560

 

Uveitis & Ocular Inflammation

 

Vitreoretinal Surgery & Retinal Disease

A Phase III, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy with Sham Injections in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD).

Condition(s) Being Treated: Geographic Atrophy secondary to Age-Related Macular Degeneration
Sponsor: Apellis Pharmaceuticals
Study Short Title: DERBY Study
Study Summary:
This is a 30-month, Phase III, multicenter, randomized, double-masked, sham-injection controlled study to assess the efficacy and safety of multiple IVT injections of APL-2 in subjects with GA secondary to AMD.
Study Status: Not Yet Enrolling
Investigator(s): Linda A. Lam, MD, MBA
ClinicalTrials.gov Information NCT03525600

 

Cornea & External Diseases

 

General Opththalmology / Genetics

Please Contact Us At 323-442-6335 For More Information On This Trial

 

Glaucoma Service

Please Contact Us At 323-442-6335 For More Information On This Trial

 

Uvetis & Ocular inflammation

 

Vitreoretinal Surgery & Retinal Disease

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