What is a clinical trial?

Clinical trials involve individuals who volunteer to assist in finding solutions to specific health-related questions. Clinical trials are a scientific and regulated way to discover new medications and treatments and a means of enhancing health. A protocol guides clinical trials and outlines matters such as the types of patients involved, test schedules and procedures, the medication used, dosages, length of the study, and the expected research outcomes. Participants in clinical trials must agree to adhere to the protocol guidelines, while researchers and health professionals must abide by precise rules established by the FDA to ensure the safety of the patients involved.

Clinical trials are conducted for a variety of reasons including, but not limited to, determining the efficacy or safety of a new drug or device, studying different ways to use treatments so that they are either easier or more effective, or advancing medicine to treat a population that wasn’t previously tested or treated.

Why should you consider participating in a clinical trial?

In some cases, participants use clinical trials because no other treatments have worked for their disease, or they are unable to handle the side effects of standard treatments. Other times, they participate because they want the opportunity to contribute to medical advancements or to have access to newer treatments before they are available to the general public.

Whatever the reason, it is important to note that all clinical trials have guidelines or “eligibility criteria” outlining who can participate. These criteria are put in place for every clinical trial to ensure that participants meet the requirements based on age, sex, stage of disease, medical history, and other variables. These requirements help to reduce the variation within the study.

Clinical trial participants should represent the patients who will ultimately use these newer treatments, if they are approved. As such, the clinical trials conducted here at Fort Lauderdale Eye Institute through the FDA seek to ensure that all eligible patients are included in clinical trials to guarantee comprehensive outcomes.

If you are interested in more information on our clinical trials, please call Noel Pereda, Clinical Research Manager, at 954-635-2861, Nathalie Rodriguez, Research Patient Coordinator, at 954-635-2864, or Helen Aguilar, Unmasked Clinical Research Coordinator, at 954-635-2862.

You may also fill out our Clinical Trial Treatment: Request More Information contact form and we will contact you as soon as possible.

Current Protocols Enrolling or Soon to be Enrolling at our Practice

COAST by Opthea Laboratories

  • A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination With Aflibercept, Compared With Aflibercept Alone, in Participants With nAMD, Study Record | Beta ClinicalTrials.gov

Elevatum by Genentech

  • Treat & Extend Versus Fixed Dosing With Faricimab for Management of Diabetic Macular Edema: A Pragmatic, Multi-center, Open-label, Randomized, Controlled Trial, Study Record | Beta ClinicalTrials.gov
  • For patients in underrepresented minorities

Parasol Dry AMD/Geographic Atrophy (81201887MDG2001) by Janssen

  • Phase 2b, randomized, double-masked, multicenter, dose-ranging, sham-controlled clinical trial to evaluate intravitreal JNJ-81201887 (AAVCAGsCD59) for the treatment of Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD). Study Record | Beta ClinicalTrials.gov

Quasar by Bayer

  • Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of Aflibercept 8 mg in Macular Edema Secondary to Retinal Vein Occlusion, Study Record | Beta ClinicalTrials.gov

Ascent by Regenexbio

  • Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants With nAMD, Study Record | Beta ClinicalTrials.gov

How are patients protected while participating in a clinical trial?

Patients are protected by the Food and Drug Administration (FDA), The National Institute of Health (NIH), and Independent Review Boards. These identities oversee all research to protect the rights and maintain the welfare of all study participants.

For more information, please visit the following websites: