For Our Patients
Clinical Trials and Research
What are
Clinical Trials?
The purpose of clinical trials is research.
Clinical trials are studies in which people volunteer either as healthy participants or those that are suffering from a particular illness to help determine whether a new treatment is safe and effective for use in the general population.
Sometimes the studies include use of a particular test agent or treatment to check its effectiveness on a disease or disease process and sometimes a study can be as simple as gathering demographic information on certain areas of the population to determine trends in the healthcare needs of the general population.
NEWS!
We are excited about the news from our North Region research program.
As we seek to extend greater care to our patients, Florida Retina Institute is leading in a number of clinical trials.
We were selected as DRCR Site of the Month again in June.
In the last quarter, we are in the Top 10 (of about 400 sites) for DRCR.
In July, we were tied for the top site in the country for the TELESCOPE trial.
And, we just received approval as a full site for the Annexon-sponsored ARCHER Trial for dry AMD.
More research opportunities may be available. If you or someone you love has been diagnosed with dry AMD, please make an appointment with one of our physicians to examine whether you may be a candidate.
August 20, 2021
Our Central Florida Region Clinical Research Staff
Primary Investigator and Clinical Research Director
Matthew A. Cunningham, MD, FASRS
Sub-Investigators
Elias C. Mavrofrides, MD
Samuel K. Steven Houston III, MD, FASRS
Jaya B. Kumar, MD, FASRS
Nisarg P. Joshi, MD
Luis G. León-Alvarado, MD
Research Coordinator, Site Manager
Angie Hunter-Hall
Research Assistants
Sophia Trewick
Nicholas Faulkner
Danilys Medina
BCVA Tech
Jennifer Gurr
Kenneth Olsen
Arianne Fernandez
Photographer
Justin Gorbea
Phase 4 Elevatum Trial - News
Phase 4 Elevatum Trial Will Observe Faricimab In Underrepresented DME Populations.
Matthew Cunningham, MD, FASRS explains the need for greater inclusion of impacted races and ethnicities in ophthalmic clinical trials. A new phase 4 clinical trial from Genentech seeks to interpret the efficacy of its newest approved ophthalmic drug, faricimab (Vabysmo) for diabetic macular edema (DME) in patients from underrepresented populations.
The Elevatum trial is enrolling Black, African American, Hispanic, Latin American and Indigenous patients with the leading cause of blindness to assess the population-based clinical efficacy and safety of intravitreal bispecific antibody Ang-2 and VEGF-A inhibitor faricimab, shortly following the drug’s approval for DME and neovascular age-related macular degeneration (nAMD) this January.
Click for more information and to see Dr. Cunningham's presentation.
Matthew A. Cunningham, MD, FASRS
Recognized for his vision in growing the Florida Retina Institute clinical research department.
Our North Florida Region Clinical Research Staff
Primary Investigator and Research Director
Benjamin J. Thomas, MD
Sub-Investigators
James A. Staman, MD
Jonathan A. Staman, MD
Abdallah M. Jeroudi, MD
Tomas A. Moreno, MD
Research Coordinator
Karen D. Yesensky, COT
Massiel Montalvo
Research Technicians
Becky Huynh
Tiffany Maximin
Austin Binninger
Clinical trials are conducted in Five Steps or Phases
When using a drug that is being tested for its safety and ability to help with certain diseases, there are five steps, or phases, that every clinical trial must go through in order to become FDA approved for use.
Each phase is designed to answer a separate research question.
Steps Explained
- Preclinical this is the initial testing that is done in the lab when a researcher has discovered a new agent or treatment that he/she feels is worthy of further testing.
- Phase 1 this phase tests the initial safety and tolerability (pharmacology) of the test drug or treatment, determines safe dosage ranges and identifies any side effects. Test population is generally 20 – 80 people.
- Phase 2 this phase tests the effectiveness, called therapeutic exploration, dose response and any further safety concerns. Test population is between 100 – 300 people.
- Phase 3 this phase confirms the effectiveness (therapeutic exploration) monitors side effects, compares to commonly used treatments and collection of information that will allow the drug or treatment to be used safely. Test population is usually between 1,000 – 5,000 people.
- Phase 4 this phase concerns itself with post marketing (therapeutic use), effectiveness in the general population and optimizing drug use. This test population is unlimited since the drug or treatment is now in use by the general population.
Participating in a clinical trial is always voluntary. There is no coercion used when offering a trial to a patient, and you can leave any clinical trial at any time for any reason.
Participation is never a determination of treatment in any clinic and you cannot be denied healthcare for leaving a clinical trial early.
Most clinical trials are sponsored by the National Institutes of Health — a federally funded organization. Other trials are sponsored by pharmaceutical and biotech companies that develop the drug or treatment.
If you would like to see a list of all clinical trials available, please click here and go to Clinicaltrials.gov, a resource provided by the U.S. National Library of Medicine. ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world. The website provides current information about clinical research studies to patients, their families and caregivers, health care professionals, and the public. Each study record includes a summary of the study protocol, including the purpose, recruitment status, and eligibility criteria. Study locations and specific contact information are listed to assist with enrollment.
For more information about clinical trials or if you should have any questions, please feel free to contact us.
