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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. Physicians can refer a patient for clinical trial consideration here.

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, Fort Worth
Wayne A. Solley, MD — Director of Clinical Research, Arlington
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: ALIMERA/A New Day

A Phase IV, randomized, masked, controlled study of intravitreal ILUVIEN® implant as baseline therapy in patients with early diabetic macular edema.

Principal Investigators:
Ashkan Abbey, MD

Study Coordinators:
Jessica Flores

Office Locations:
Dallas Main

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:
Jessica Flores

Office Location:
Dallas Main

Title: ROCHE – BP43464

A Phase II, multi-center, randomized, double-masked, active comparator-controlled study to investigate the efficacy and safety, tolerability, pharmacokinetics and pharmacodynamics of R07200220 administered in combination with ranibizumab intravitreally.

Principal Investigators:
Wayne Solley, MD

Study Coordinators:
Melissa Alva

Office Locations:
Arlington

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: APX3330 (Ocuphire) 

A Phase II, randomized, placebo-controlled, double-masked study of the safety and efficacy of orally administered APX3330 in subjects with moderately severe to severe non-proliferative diabetic retinopathy and mild proliferative diabetic retinopathy.

Principal Investigator:
Patrick Williams, MD

Study Coordinator:
Tina Bell

Office Location:
Fort Worth

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: Glow

A Phase III, two-year, sham-controlled study for patients 18 years old or older with type I or II diabetes and treatment naïve moderately severe to severe non-proliferative diabetic retinopathy (NPDR). Their HbA1c must be 12% or less, vision better than 20/40, and a central OCT thickness of less than 320 microns. Subjects enrolled in the study will be randomized to one of two groups. Group A will receive the study drug, KSI-301, every 24 weeks. Group B will receive sham injections every 24 weeks. If a subject in either group develops a sight-threatening complication, they will then be treated with open-label KSI-301. Study duration is approximately two years.

Principal Investigator:
Lori Coors, MD

Study Coordinator:
Tara Keesling, COA

Office Location:
Plano

Title: Indigo

Quantitative evaluation of retinal function in eyes with diabetic retinopathy treated with anti-VEGF.

Principal Investigator:
David Callanan, MD

Study Coordinator:
Melissa Alva

Office Location:
Arlington

Title: ARCHER (Annexon ANX007-GA-01)

A Phase II, multi-center, randomized, parallel-group, double-masked, 4-arm, sham-controlled study of the efficacy, safety and tolerability of ANX007 administered by intravitreal injection in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Principal Investigator:
Patrick Williams, MD

Study Coordinator:
Lori Hastings

Office Location:
Fort Worth

Title: Gyroscope EXPLORE — Gene Therapy
Gyroscope HORIZON — Gene Therapy

Sister studies — A Phase II, open-label, outcomes-assessor masked, multi-center, randomized, controlled study to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to dry age-related macular degeneration (AMD).

Principal Investigator:
Ashkan Abbey, MD

Study Coordinator:
Ashley Hughes

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

Study Coordinator:
Melissa Alva

Office Location:
Arlington

Title: TELESCOPE

A study for patients 55 or older with unilateral or bilateral geographic atrophy due to age-related macular degeneration. This is a one-time visit, and patients will need to provide a saliva sample which will be sent to a laboratory for analysis. Patients meeting the pre-specified genotype criteria may be given the option to participate in a further, separate Gyroscope Therapeutics interventional gene therapy trial.

Title: ASCENT – RGX-314-3101

A a multi-center, randomized, active-controlled trial to evaluate the efficacy and safety of a single administration of sub retinal gene therapy RGX-314 versus standard of care in patients with wet AMD.

Title: ATMOSPHERE – RGX-314-2104

A randomized, partially masked, controlled, Phase IIb/III clinical study to evaluate the efficacy and safety of RGX-314 Gene Therapy in participants with neo-vascular age-related macular degeneration.

Principal Investigators:
Ashkan Abbey, MD

Study Coordinators:
Ashley Hughes, COT

Office Locations:
Dallas Main

Title: BioReactor – RGX-314-2103

A  Phase II, open-label study to explore the pharmacodynamics of two doses in two formulations of RGX-314 gene therapy administered via subretinal delivery in participants with neovascular age-related macular degeneration.

Principal Investigators:
Ashkan Abbey, MD

Study Coordinators:
Ashley Hughes, COT

Office Locations:
Dallas Main

Title: DAYLIGHT

A Phase III, 47-week study for patients 50 years old or older with active and treatment naïve Wet AMD. Their vision must be between 20/25+3 and 20/320, and a central CNV are at least 50% of the total lesion. Subjects enrolled in the study will be randomized to one of two groups. Group A will receive the study drug, KSI-301, once every 4 weeks from Day 1 to Week 36. Group B will receive three monthly loading doses of aflibercept then once every eight weeks until Week 36. Sham injections will be performed at each visit when aflibercept is not administered to protect masking. Study duration is approximately 1 year (47 weeks).

Principal Investigators:
Lori Coors, MD

Study Coordinators:
Tara Keesling, COA

Office Locations:
Plano

Title: OPTHEA-OPT-302-1004

A Phase III, multi-center, double-masked, randomized study to evaluate the efficacy and safety of intravitreal OPT-302 in combination with ranibizumab, compared with ranibizumab alone, in participants with treatment naïve, neovascular, age-related macular degeneration.

Title: PORTAL

This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) 100 mg/mL with refill-exchanges administered every 24 weeks (Q24W) or every 36 weeks (Q36W) for approximately 240 weeks in participants with neovascular age-related macular degeneration who have completed either Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway) or Phase IIIb Study WR42221 (Velodrome).

Principal Investigator:
Patrick Williams, MD

Study Coordinators:
Lori Hastings

Office Location:
Fort Worth

Title: SANDOZ

A 52-week, multi-center, randomized, double-masked, 2-ARM parallel study to compare efficacy, safety and immunogenicity of SOK583A1 to Eyelea®, administered intravitreally, in patients with neovascular age-related macular degeneration.

Principal Investigator:
Wayne Solley, MD

Study Coordinators:
Angie Torres

Office Location:
Arlington

Title: TRS4Vision (TRS01 Eye Drops)

A Phase III clinical trial of a steroid-free drop (TRS01) in the treatment of subjects with active non-infectious anterior uveitis, including subjects with uveitic glaucoma. Throughout the duration of this randomized, double-masked study, the safety and efficacy of TRS01 eye drops will be evaluated and compared to standard of care steroid eye drops. Participation is limited to subjects 70 years of age or younger (including children of all ages) who have active non-infectious anterior uveitis and are currently without treatment or on a stable dose of their current treatment. Subjects will be followed for 6 weeks over the course of 6 office visits.

Principal Investigators:
Robert Wang, MD

Study Coordinator:
Veronica L. Bennett, COA

Office Locations:
Plano

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.

Principal Investigators:
Robert Wang, MD (Dallas Main)

Study Coordinators:
Sally Arceneaux (Dallas Main)

Office Locations:
Dallas Main

Title: YUTIQ CALM REGISTRY STUDY 

A fluocinolone acetonide intravitreal implant for the treatment of chronic, non-infectious uveitis affecting the posterior segment.

Study Coordinator:
Rene Choi, MD

Study Coordinator:
Tara Keesling

Office Location:
All Offices

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.