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World-Class Retina Care. Community-Based Caring.

Research

In the last decade, medical researchers have made significant advances in the diagnosis and treatment of a number of retina conditions, discovering new sight-saving treatments for diseases that once robbed patients of their vision.

At Texas Retina Associates, we are committed to conducting ongoing research that will improve care for our patients—a value instilled by the pioneering physicians who founded our practice more than 50 years ago. In fact, our research program has grown to become one of the largest in the country for a community-based practice and rivals those of some of the largest academic medical centers.

Over the past 20 years, our physicians have participated in more than 75 national clinical trials, offering our patients access to promising new treatments for a variety of retina conditions, including age-related macular degeneration, diabetic macular edema, diabetic retinopathy, and uveitis.

We conduct clinical trials in our Dallas, Arlington, Lubbock, Fort Worth and Plano offices. Current study and location availability varies. Please contact our research department at (214) 692-6885, ext. 1, for more information or to determine eligibility for our current clinical trials.

Our clinical research leadership team includes the following physicians:

Ashkan M. Abbey, MD — Director of Clinical Research, Dallas
Robert C. Wang, MD — Director of Clinical Research, Plano
Patrick D. Williams, MD — Director of Clinical Research, Arlington
Wayne A. Solley, MD — Director of Clinical Research, Fort Worth
Michel J. Shami, MD — Director of Clinical Research, Lubbock

Current Clinical Trials Available

Title: Aura

A Phase II trial of AU-011 via suprachoroidal administration with a dose escalation phase (open-label, ascending single and repeat dose) and a randomized, masked dose expansion phase designed to evaluate the safety and efficacy of AU-011 in subjects with primary indeterminate lesions and small choroidal melanoma.

Principal Investigator:
Timothy S. Fuller, MD

Study Coordinator:
Sally Arceneaux

Office Location:
Dallas Main

Title: COED

A Phase III, one-year study for patients 18 years or older with diabetic macular edema and Type I or Type II diabetes. If previous treatment, must have a “wash out” period of three months. Patients enrolled in the study will be randomized in one of two groups. Group one will be treated with Eylea and Ozurdex, and group two will be treated with Eylea only.

Title: Glimmer

A Phase III, two-year study for patients 18 years old or older with type I or II diabetes and treatment naïve DME. Their HbA1c must be 12% or less, vision between 20/25 and 20/320, and a central OCT thickness of 320 microns or greater. Subjects enrolled in the study will be randomized to one of two groups. Group A will receive the study drug, KSI-301, per an individualized study treatment regimen after three monthly loading doses. Group B will receive aflibercept every eight weeks after five monthly loading doses. Sham injections will be performed when a study treatment is not required to protect masking. Study duration is two years.

Principal Investigators:
Lori Coors, MD

Study Coordinators:
Tara Keesling

Office Locations:
Plano

Title: Oxurion

A Phase II, six-month study for patients 18 years old or older with diabetic macular edema that has had previous anti-VEGF treatment and Type I or Type II diabetes. The enrolled patients will all receive the investigational product THR-149 and will be randomized into one of three groups: group A will be treated with THR-149 0.01mg, group B with THR-149 0.04 mg, and group C with THR-149 0.13 mg.

Principal Investigator:
Ashkan Abbey, MD

Study Coordinator:
Karen Duignan

Office Location:
Dallas Main

Title: Pagoda

A Phase III, multi-center, randomized, double-masked, two-year study for patients 18 years or older with diabetic macular edema. If previous treatment, must have a “wash out” period of six months. The enrolled patients will be randomized into two groups: Group 1 — PDS (port delivery system) implant and will receive loading doses of Lucentis, Group 2 – Intravitreal Arm and will receive Lucentis until week 64 and then will receive the PDS implant.

Title: Diabetic Clinical Research Network Study Protocol AC — Aflibercept vs. Bevacizumab with Deferred Aflibercept for DME

The objective of this study is to compare the efficacy of intravitreous aflibercept with intravitreous bevacizumab + deferred aflibercept if needed in eyes with DME and moderate vision loss.

Principal Investigator:
Michel Shami, MD

Study Coordinator:
Yolanda Saldivar

Office Location:
Lubbock

Title: Diabetic Clinical Research Network Study Protocol W – Intravitreous Anti-VEGF Treatment for Prevention of Vision Threatening Diabetic Retinopathy in Eyes at High Risk

The objective of this study is to determine the efficacy and safety of intravitreous aflibercept injections versus sham injections (observation) for prevention of PDR or CI-DME in eyes at high risk for development of these complications and compare long-term visual outcomes in eyes that receive anti-VEGF therapy early in the course of disease with those that are observed initially, and treated only if high-risk PDR or CI-DME with vision loss develops.

Principal Investigator:
Michel Shami, MD

Study Coordinator:
Yolanda Saldivar

Office Location:
Lubbock

Title: Diabetic Clinical Research Network Study Protocol Protocol AB – Intravitreous Anti-VEGF vs. Prompt Vitrectomy for Vitreous Hemorrhage from Proliferative Diabetic Retinopathy

The objectives of this study are to evaluate and compare visual acuity outcomes over the course of the study of a prompt vitrectomy + PRP regimen and an intravitreous aflibercept regimen in eyes with VH from PDR for which intervention is deemed necessary, and characterize the follow-up course for the two treatment regimens, including but not limited to post-operative complications for the vitrectomy group, and number of injections needed and percent requiring vitrectomy in the intravitreous aflibercept group.

Principal Investigator:
Michel Shami, MD

Study Coordinator:
Yolanda Saldivar

Office Location:
Lubbock

Title: Pavilion

A Phase III, two-year study for patients 18 years or older with treatment naive non-proliferative diabetic retinopathy. The enrolled patients will be randomized into two groups: group 1 — PDS (port delivery system) implant and will receive loading doses of Lucentis, and group 2 — intravitreal arm and will receive Lucentis until week 64 and then will receive the PDS implant.

Principal Investigator:
Ashkan Abbey, MD

Study Coordinator:
Karen Duignan

Office Location:
Dallas Main

Title: Stealth — SPIAM-202

A Phase II study for geographic atrophy due to age-related macular degeneration (AMD) in patients age 50 or older. This study will have two groups: group one will be treated with daily subcutaneous injections of Elamipretide (ReCLAIM-2), and the second group will have a placebo.

Principal Investigator:
Patrick Williams, MD

Study Coordinator:
Tina Bell

Office Location:
Fort Worth

Title: CATALINA

A Phase II, one-year study for patients 55 to 89 years of age with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD) and treatment naive to both eyes. Patients enrolled in the study will be randomized to four treatment groups: study treatment every 4 weeks or every 8 weeks, or sham treatment every 4 weeks or every 8 weeks.

Principal Investigator:
Ashkan Abbey, MD

Study Coordinator:
Sally Arceneaux

Office Location:
Dallas Main

Title: Gemini

A Phase II, open-label, seven-month study for patients 50 years or older with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) and treatment naive in study eye. Randomized to monthly or every other month treatment.

Principal Investigator:
Ashkan Abbey, MD

Study Coordinator:
Sally Arceneaux

Office Location:
Dallas Main

Title: Beacon

A Phase III, one-year study for patients 18 years old or older with treatment naïve visual impairment secondary to RVO (BRVO/CRVO/HRVO). The subjects vision must be between 20/25 and 20/320 with a central OCT thickness of 320 microns or greater. Subjects enrolled in the study will be randomized to one of two groups. Group A will receive the study drug, KSI-301, every eight weeks after two loading doses, followed by a six-month individualized treatment regimen. Group B will receive aflibercept monthly aflibercept for six doses followed by a six-month individualized treatment regimen. Sham injections will be performed when a study treatment is not required to protect masking. Study duration is one year.

Principal Investigator:
Robert C. Wang, MD

Study Coordinator:
Tara Keesling

Office Location:
Plano

Title: Amgen, Inc.

A Phase III, one-year study  for patients age 50 or older with wet macular degeneration. This study will have two groups: group A will be treated with investigational ABP938 injections, and group B will be treated with Eylea® only.

Title: Candela

A Phase II, one-year study  for patients 50 years or older with naive (wet) age-related macular degeneration (AMD). Patients enrolled will be randomized to one of two groups. Group A will be treated with Eylea (2mg), and group B will be treated with Eylea (8mg).

Principal Investigator:
Ashkan Abbey, MD

Study Coordinator:
Karen Duignan

Office Location:
Dallas Main

Title: Ionis

The study will evaluate the effects of IONIS-FB-LRx on the rate of change of the area of geographic atrophy secondary to age-related macular degeneration (AMD).

Principal Investigator:
David Callanan, MD (Arlington)

Study Coordinator:
Melissa Alva (Arlington)

Office Location:
Arlington

Title: PULSAR

A randomized, double-masked, active-controlled, Phase 3 study of the efficacy and safety of high-dose aflibercept in patients with neovascular age-related macular degeneration (AMD)

Principal Investigator:
Patrick Williams, MD (Fort Worth)

Study Coordinators:
Lori Hastings (Fort Worth), Tina Bell (Fort Worth)

Office Location:
Fort Worth

Title: Lumina 

A Phase III, multi-center, sham-controlled, randomized, double-masked study assessing the efficacy and safety of intravitreal injections of 440 ug DE-109 for the treatment of active non-infectious uveitis of the posterior segment of the eye.

Title: Electro — Protocol EYS606-CT2 

A 48-week, Phase II, randomized, open-label, multi-center study to evaluate the efficacy and safety of two EYS606 treatment regimens in subjects with active chronic non-infectious uveitis (CNIU).

Principal Investigator:
David Callanan, MD

Study Coordinator:
Angie Torres

Office Location:
Arlington

Title: Acthar 

A Phase II, open-label, two-dose, randomized, one-year study for patients 21 years or older with non-infectious uveitis.

Principal Investigator:
Robert Wang, MD

Study Coordinator:
Sally Arceneaux

Office Location:
Dallas Main

About Clinical Trials

Clinical trials are research studies that test how a medical approach works on people.  They are the primary way that researchers find out if a new treatment is safe and effective in people. Clinical trials are also used to:

  • Learn if a new treatment is more effective and/or has less harmful side effects than the current standard treatment
  • Test ways to more effectively screen for or diagnose a disease earlier
  • Test ways to prevent a disease or condition
  • Determine which medical treatments work best for specific stages of a disease or group of people

Most of the clinical trials at Texas Retina Associates compare a new medical approach to a standard one already in use.

The United States Food and Drug Administration (FDA) must approve all clinical trials before they begin. Before this approval, scientists perform laboratory tests and studies in animals to test a potential therapy’s safety and efficacy. If these studies show favorable results, the FDA gives approval for the intervention to be tested in humans.

Clinical trials advance through four phases to test a treatment, find the appropriate dosage, and look for side effects. If, after the first three phases, researchers find a drug or other intervention to be safe and effective, the FDA approves it for clinical use and continues to monitor its effects.

All of the clinical trials offered at Texas Retina Associates have gone through a rigorous review process.

What to Expect/Frequently Asked Questions

Who conducts clinical trials at Texas Retina Associates?

Each clinical trial is led by one of our physicians who serves as a Principal Investigator (PI). The research team typically includes this physician as well as one of our research coordinators and an ophthalmic technician. They will guide you through the clinical trial, including exams, treatment, follow up and data collection. The duration of treatment and the required number and frequency of office visits will vary by study, and you will be informed when you consent to participate.

Who can participate in a clinical trial?

Each study has its own inclusion and exclusion criteria. If your Texas Retina Associates physician recommends you for a study, one of our clinical research coordinators will talk to you about the requirements for that specific study and can help determine your eligibility.

What are the benefits of participating in a clinical trial?

By participating in a clinical trial, you may receive a new, more effective treatment that is not yet available to the public. You are also contributing to the advancement of care and treatment for a particular eye disease or condition. This could have a positive impact on future patients, including family members, who may have the same condition.

How much does it cost?

In many clinical trials, treatment costs are paid for by the study sponsor. In some cases, expenses for treatment of the other eye may also be covered. Costs vary by study and will be explained to you prior to participation.

Will I be compensated for participating in a clinical trial?

Some studies provide participants with compensation for their time and participation. This will vary by study and will be shared with you prior to enrolling.

If the treatment works, can I continue it after the study is over?

This depends upon whether or not the drug has been approved by the FDA. If not yet approved, you cannot continue taking the study drug after the study has concluded. If it is approved by the FDA, it may be possible for you to continue taking it off-label if prescribed by your physician. Your Texas Retina doctor will talk to you about treatment options available to you at the conclusion of the study.

Research Partnerships

In the quest to better understand the root causes and progression of retina diseases as well as to uncover new treatment options, our three founding physicians — Drs. Vaiser, Snyder and Hutton — helped establish the Retina Foundation of the Southwest.

And in 2013, we moved our Dallas Main office to a custom-designed, shared home with the Retina Foundation of the Southwest to provide our patients with more immediate, expanded and direct access to breakthrough treatments and clinical trials. This has allowed us to more quickly and easily translate research from the lab to patient care.

We also partner with pharmaceutical companies, the National Eye Institute, and other retina practices throughout the country to better understand retinal conditions and to study potential new, sight-saving treatment options for our patients.