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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.

Current Clinical Trials Available

Title: Ora, Inc. KVD001-201

A randomized, sham-controlled, double-masked, Phase 2 study of the efficacy, safety and tolerability of the intravitreal plasma Kallikrein inhibitor in subjects with center-involving diabetic macular edema who had prior (VEGF) treatment.

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 Investigators:
Michel Shami, MD

Study Coordinators:
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 Investigators:
Michel Shami, MD

Study Coordinators:
Yolanda Saldivar

Office Location:
Lubbock

Title: Diabetic Clinical Research Network Study Protocol 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 caflibercept if needed in eyes with CI DME and moderate vision loss.

Principal Investigators:
Michel Shami, MD

Study Coordinators:
Yolanda Saldivar

Office Location:
Lubbock

Diabetic Clinical Research Network Study Protocol Protocol TX – Aflibercept, Bevacizumab and Ranibizumab Comparison for DME Follow-up Extension Study

This is an extension study for Protocol T. It is not recruiting new participants. Patients are returning for a five-year visit only.

Principal Investigators:
Michel Shami, MD

Title: Graybug Vision Inc. GBV-102-001

A Phase 1/2 multi-center study evaluating the safety, tolerability, and efficacy of an intravitreal depot formulation of sunitinib malate (GB-102 ) in subjects with neovascular age-related macular degeneration.

Principal Investigators:
David Callanan, MD

Study Coordinators:
Michelle Curry

Office Location:
Arlington

Title: Allergan 1771-201-008

A Phase 2, multi-center, open-label, 28-week study to evaluate abicipar for safety and treatment effect in patients with neovascular AMD.

Principal Investigators:
David Callanan, MD

Study Coordinators:
Michelle Curry

Office Location:
Arlington

Title: Clearside CLS1003-301

A Phase 3, randomized, masked, controlled trial to study the safety and efficacy of suprachoroidal CLS-TA in conjunction with intravitreal aflibercept in subjects with retinal vein occlusion.

Title: Clearside CLS1003-302

A Phase 3, randomized, masked, controlled trial to study the safety and efficacy of suprachoroidal CLS-TA in combination with an intravitreal anti-VEGF agent in subjects with retinal vein occlusion.

Title: Aldeyra Therapeutics Inc. ADX-102-UV-005

A Phase 3, randomized, double-masked, vehicle-controlled trial to evaluate the safety and efficacy of ADX-102 ophthalmic solution in subjects with non-infectious anterior uveitis.

Principal Investigators:
Robert Wang, MD

Study Coordinators:
Sally Arceneaux

Office Location:
Dallas

Title: OIRRC – Acthar Study

A Phase 2, open-label, multi-center, randomized study of the safety and bioactivity of two-dose regiments of subcutaneous injections of ACTH gel in patients with non-infections uveitis.

Title: Gilead Sciences GS-US-432-4097

A Phase 2, randomized, placebo-Controlled trial evaluating the efficacy and safety of filgotinib in subjects with active non-infectious uveitis.

Principal Investigators:
David Callanan, MD (Arlington)

Study Coordinators:
Melissa Alva (Arlington)

Office Locations:
Arlington

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.