What Is A Clinical Trial?
A clinical trial is designed to explore the latest treatments available for people diagnosed with diseases such as macular degeneration, diabetic retinopathy, or vein occlusions. The participant will undergo an initial screening to determine eligibility. If suitable, the volunteer will be able to receive one of several treatment options. These clinical trials are regulated through the Food and Drug Administration (FDA) and the National Institute of Health (NIH) to protect the patient’s rights, safety, and welfare.
Why Should You Choose to Participate in a Clinical Trial?
Individuals choosing to participate in a clinical study may be the first to benefit from treatment options that are not yet available to the public, along with complimentary eye exams at every visit. All diagnostic tests and treatments are also provided to the patient at no cost.
The doctors at RMI have a long history of commitment to and participation in clinical trials. This is to insure that we provide our patients access to new, state-of-the-art preventative or therapeutic treatments. Dr. Ron Gallemore has been an investigator in more than 60 clinical trials.
If you would like to learn more about our clinical trial options or determine your eligibility for a study, please call us at (310) 944-9393.
If you are a doctor who is looking to learn more about these studies or refer patients into a study, please give us a call at (310) 944-9393 to speak to one of our clinical research personnel.
If you are a patient who would like to determine if you are a candidate and want to receive additional information, please give us a call at (310) 944-9393 to speak to one of our clinical study representative.
Hours of Operations:
Monday-Friday: 8am- 6pm If you have reached a message after hours, please complete the questionnaire and a study personnel will contact you on the next business day.
Trials No Longer Enrolling Patients
The following studies are now closed for enrollment, but currently-enrolled patients are still being closely monitored:
Wet Macular Degeneration:
SURF – a one-year trial, sponsored by Genentech, researching the following questions: Is microperimetry and multi-focal ERG more accurate than OCT in making early predictions regarding retreatment? Does OCT success affected by Monthly and PRN treatment. Does 0.5mg therapy versus 2.0mg therapy make a difference? Diagnostic testing includes but is not limited to optical coherence tomography, fluorescein angiography, microperimetry, and multi-focal ERG. The study also pays for Lucentis, if needed for the other eye.
HARBOR – a two-year trial sponsored by Genentech comparing the safety and efficacy of a higher versus standard dosage of Lucentis, administered monthly or on as-needed basis. Diagnostic testing includes but is not limited to optical coherence tomography, fluorescein angiography, and routine laboratory tests, at no charge. The study also pays for Lucentis if needed for the other eye.
REGENERON-VIEW1 – is a two-year trial comparing Lucentis and the VEGF –trap molecule, in varying doses. Diagnostic testing includes but is not limited to optical coherence tomography, fluorescein angiography, routine electrocardiograms and laboratory tests at no charge.
Advanced Dry Macular Degeneration:
GATE – a three-year trial sponsored by Alcon, comparing the experimental drug (AL-8309B) to a placebo drop, for safety and efficacy. This will be administered twice a day. Following the randomization visit, patients are seen every 3 months. Routine fundus autofluorescence and laboratory tests are included at no charge.
Diabetic Macular Edema:
READ3 – a one year study investigating the safety, bioactivity, dose response to and tolerability for two different dosages (0.5mg and 2.0mg) of ranibizumab (RBZ) in patients with diabetic macular edema. Diagnostic testing (DME) includes but is not limited to optical coherence tomography, microperimetry, fluorescein angiography, and hemoglobin A1C measurement, at no charge. The fellow eye may receive study medication at no cost if it meets the inclusion and exclusion criteria.
NEVANAC IST – a one year trial sponsored by Alcon and investigating the efficacy of Nepafenac as an adjunctive therapy to focal grid laser. Diagnostic testing includes, but is not limited to optical coherence tomography, fluorescein angiography, routine electrocardiograms and laboratory tests, at no charge. Following the screening visit, enrolled patients are seen every 2 months.
PRESERVE – a 24-week trial comparing the administration of intravitreal Macugen injections, every 4 weeks versus every 6 weeks. Diagnostic testing includes but is not limited to optical coherence tomography, microperimetry, fluorescein angiography, and hemoglobin A1C measurement, at no charge.
REGENERON-COPERNICUS – a two-year trial assessing the safety, efficacy, and tolerability of the repeated intravitreal administration of VEGF Trap-eye compared to standard of care for treatment of macular edema, as a secondary condition to central retinal vein occlusion.
Wet Macular Degeneration:
RADICAL – a study comparing a combination therapy of Visudyne and Lucentis versus the combination of Visudyne, Lucentis, and Dexamethasone, in patients who have undergone no previous treatments for macular degeneration.
DENALI – a study comparing Lucentis monotherapy and a combination therapy of Visudyne and Lucentis, in patients who have undergone no previous treatments for macular degeneration.
BRAVO/CRUISE – a study comparing sham versus Lucentis injections, following laser rescue treatment (after three months in the trial).
HORIZON – an extension study, which allows eligible patients, who have completed participation, in previous vein occlusion studies, to continue receiving treatment.