For Our Patients
Clinical Trials and Research
Enrolling in
a Study
Thank you for your interest in enrolling in one of our studies.
New patients interested in participating in a clinical trial and in enrolling to possibly receive the newest, most advanced treatment for their vitreoretinal conditions, with the care and attention from our professional clinical trial staff.
Enrolling in a Study
New patients interested in enrolling a study, please click on the Enroll in this Study to send us an email. Include your name, the reason of your interest in this study and the office location you receive treatment. You will receive a reply from us within 48 - 72 hours.
The following studies are currently available for enrollment.
For Central Florida Patients
Hornbill Study
Diabetic Retinopathy with Diabetic Macula Ischemia
Central Florida Patients
A Study to Test Different Doses of BI 764524 in Patients Who Have Had Laser Treatment for a Type of Diabetic Eye Disease Called Diabetic Retinopathy With Diabetic Macular Ischemia (HORNBILL).
This is a study in people with a type of diabetic eye disease called diabetic retinopathy with diabetic macular ischemia. People who have had laser treatment for their diabetic retinopathy can participate in the study. The laser treatment is called panretinal photocoagulation.
The purpose of the study is to find out how well different doses of a medicine called BI 764524 are tolerated. BI 764524 is injected into the eye. The study has 2 parts. In the first part, participants get different doses of BI 764524 only once.
Participants are in the first part for about 5 months and visit the study site about 8 times. In the second part, participants are put into different groups by chance. Some participants get BI 764524 injections every 4 weeks. Other participants get sham injections every 4 weeks. A sham injection means that it is not a real injection and contains no medicine. Participants cannot tell whether they get the real injection or a sham injection. For the second part, participants are in the study for about 7 months. During this time, they visit the study site about 7 times. In this study, BI 764524 is given to humans for the first time.
The doctors compare how well people tolerate the BI 764524 injections and the sham injections. The doctors also regularly check the general health of the participants.
Visit https://clinicaltrials.gov/ct2/show/NCT04424290 for more information about the Hornbill Study.
New Day Study
Diabetic Macula Edema
Central Florida Patients
A Randomized, masked, controlled study of and intravitreal ILUVIEN implant as baseline therapy in patients with early Diabetic Macular Edema.
Kodiak P104 (Gleam) Study
Diabetic Macula Edema
Central Florida Patients
Randomized, double masked Phase 3 study to evaluate the efficacy and safety of intravitreal KSI-301 compared with intravitreal Aflibercept in participants with visual impairment secondary to treatment-naïve patients with diabetic macular edema (GLEAM and GLIMMER) and macular edema due to retinal vein occlusion (BEACON).
Kodiak P103 (Beacon) Study
Macular Edema Secondary to Retinal Vein Occlusion
Central Florida Patients
A randomized, double masked Phase 3 study to evaluate the efficacy and safety of intravitreal KSI-301 compared with intravitreal Aflibercept in participants with visual impairment secondary to treatment-naïve Macular Edema secondary to Retinal Vein Occlusion.
Protocol PU-AD-SD-0201 – Samus Therapeutics, Inc.
Central Florida PatientsA Phase 2A study to evaluate safety, tolerability and pharmacological effect of PU-AD in subjects with mild Alzheimer’s Disease (AD) dementia - This study is in conjunction with Conquest Research, LLC.
Protocol GS-US-389-3933 – Gilead Sciences, Inc.
Central Florida PatientsA Phase 1 Open-Label, Parallel-Group, Adaptive, Single-Dose Study to Evaluate the Pharmacokinetics of GS-9688 in Subjects with Normal and Impaired Hepatic Function - This study is in conjunction with Orlando Clinical Research Center.
Protocol GO29665
Central Florida PatientsPhase I/II, Open-Label, Dose-Escalation Study Of The Safety And Pharmacokinetics of Cobimetinib In Pediatric And Young Adult Patients With Previously Treated Solid Tumors.
Please find additional helpful information about this clinical trial at:NIH U.S. National Library of Medicine, ClinicalTrials.gov - Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Participants With Previously Treated Solid Tumors (iMATRIXcobi) Summary: This open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of cobimetinib in pediatric and young adult participants with solid tumors with known or potential kinase pathway activation for which standard therapy has proven to be ineffective or intolerable or for which no curative standard-of-care treatment options exist. The study will be conducted in two stages: a dose-escalation stage and an expansion stage at the recommended dose.
Orlando Health, Arnold Palmer Hospital for Children - Study of Safety & PK of Cobimetinib Pts w/Solid Tumors A Phase I/II, Multicenter, Open-Label, Dose-Escalation Study Of The Safety And Pharmacokinetics Of Cobimetinib In Pediatric And Young Adult Patients With Previously Treated Solid Tumors.
Protocol GO29665 is partnered with Orlando Health, Arnold Palmer Hospital for Health
This study is closed for enrollment but actively seeing current patients for 4 years-duration of study.
For North Florida Patients
DRCR-Protocol AF
Diabetic Retinopathy
North Florida Patients
Status: Recruiting
A Randomized Clinical Trial Evaluating Fenofibrate for Prevention of Diabetic Retinopathy Worsening.
Précis. This randomized trial will evaluate the effect of fenofibrate compared with placebo for prevention of diabetic retinopathy (DR) worsening through 4 years of follow-up in participants with mild to moderately severe non-proliferative DR (NPDR) and no CI-DME at baseline.
Investigational Drug: Fenofibrate (new indication)
In addition to evaluating efficacy, this study aims to evaluate the feasibility of a model for ophthalmologists to prescribe or collaborate with a primary care provider such as an internist/endocrinologist to prescribe and monitor the drug safely.
If this study demonstrates that fenofibrate is effective for reducing the onset of proliferative diabetic retinopathy (PDR) and the results are adopted by the community of retina specialists, a new strategy to prevent vision threatening complications of diabetes could be widely adopted. Widespread use of an oral agent effective at reducing worsening of DR would decrease the numbers of patients who undergo more invasive and much more expensive treatment for DR and who are consequently at risk for side effects that adversely affect visual function.
This study will also assess the relationship of glycemic variability as measured by continuous glucose monitoring with DR outcomes.
Ancillary studies will characterize functional and structural outcomes in this cohort.
Visit the DRCR Retina Network JCHR JAEB Center for Health Research public website at https://public.jaeb.org/drcrnet/stdy/568 for more information about the DRCR-Protocol AF Study.
DRCR-Protocol AJ
Macular Hole
North Florida Patients
Vitreous Proteomics in Eyes with a Macular Hole. The main objective of this protocol is to verify and characterize abnormally expressed vitreous proteins in adults with macular hole and to identify biological pathways involved in the pathogenesis of macular hole formation and potential targets for therapeutic intervention.
Protocol DRCR GEN-Genetics in Retinal Diseases
North Florida PatientsProtocol GEN-Genes in Diabetic Retinopathy. General Information for a Patient Who May Want to Be a Participant in this study.
To better understand the effects of diabetes on the retina, the Diabetic Retinopathy Clinical Research Network (DRCR.net) is collecting a blood sample from people with diabetes. The blood sample will be used to extract DNA. DNA is the part of a cell that contains unique genetic information. It is hoped that through studies done on the DNA, scientists will develop a better understanding of how diabetes causes changes in the retina and how diabetic retinopathy can best be treated.
Scientists will be able to request the samples, DNA information, and/or other medical information that are available in this database for their research on diabetes, complications from diabetes, such as diabetic retinopathy, or other diseases. Each request will need to be approved by the Diabetic Retinopathy Clinical Research Network or a National Institutes of Health data access committee before the samples or information will be given to the scientists. If the request is approved, the scientist will be given the samples and the information that was collected about your diabetes, other medical conditions, treatments and eye exams. No information that can directly identify you will be given.
If you agree to be part of this study, we will collect one or two tubes of blood from you. Each tube will contain about 10 mL (about 2 teaspoons) of your blood. The blood sample will be sent to a central storage repository.
Regeneron Protocol 20968 (PULSAR)
North Florida PatientsRandomized, Double-Masked, Active-Controlled, Phase 3 Study of Efficacy and Safety of High Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration. The Primary objective of this study is to determine if treatment with aflibercept 8 mg (HD) at intervals of 12 or 16 weeks provides non-inferior BCVA change compared to aflibercept 2 mg every 8 weeks in participants with nAMD.
For more information about clinical trials or if you should have any questions, please feel free to contact us.
