Clinical Research Trials:
The doctors at Retina Consultants of Orange County are committed to bringing the most advanced medical and surgical care available. As part of this commitment, we are improving upon current treatments through research. Research studies include only people who choose to take part, and only those patients who qualify. Each trial has different requirements for enrollment. Patients are encouraged to take their time in making a decision about participating; and can discuss the decision with their family or friends. Any study related questions can be answered by the doctors or clinical research coordinator.
Clinical Trial Phases
Clinical research trials are conducted in a series of phases; each one is designed to answer a separate research question about the investigated drug.
- Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
- Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
- Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
- Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
Macular Degeneration, Diabetes, and Diabetic Retinopathy
We are currently enrolling Phase II trials for neovascular age-related macular degeneration and non-proliferative diabetic retinopathy. We will soon be actively enrolling Phase III diabetic trials focusing on new treatments for age-related macular degeneration, geographic atrophy, and diabetic macular edema, proliferative and non-proliferative diabetic retinopathy.
ZIMURA | Protocol: OPH2007
A Six-Month, Phase IIA Open-Label trial to assess the safety of Zimura (Anti-C5) administered in combination with Lucentis 0.5mg in treatment naïve patients with neovascular age-related macular degeneration.
AERPIO | Protocol: AKB-9775-CI-5001
A Twelve-Month, Phase II Double-Masked, Placebo-Controlled trial to assess the safety and efficacy of subcutaneously administered AKB-9778 15mg once daily or 15mg twice daily for 12 months in patients with moderate to severe non-proliferative diabetic retinopathy.
CEDAR | Protocol: 150998-005
A Two-Year, Phase III, Randomized, Double-Masked trial to assess the efficacy and safety of Abicipar Pegol eye injections at eight and twelve week intervals vs. patients receiving Lucentis monotherapy injections in four week intervals. For treatment naïve patients with neovascular age-related macular degeneration.
MAKO | Protocol: OHR-1601
A Two-Year, Phase III, Randomized, Masked, Multicenter, study comparing the efficacy and safety of Squalamine Lactate 0.2% twice daily eye drops vs. sham drops; coinciding with Lucentis injections every four weeks. For treatment naïve patients with neovascular age-related macular degeneration.
BOULEVARD | Protocol: BP30099
A 36-Week, Phase III, Randomized, Multi-Dose, Multicenter, Active Comparator-Controlled, Double Masked, Parallel Group Study to investigate the safety, tolerability, pharmacokinetics and efficacy of RO6867461 administered intravitreally in patients with diabetic macular edema.
PANORAMA | Protocol: VGFT3e-OD-1411
A Two-Year, Phase III, Double-Masked, Randomized, Multicenter study of the efficacy and safety of intravitreal Aflibercept injection in patients with moderately severe to severe nonproliferative diabetic retinopathy.
SPECTRI | Protocol: GX29185
A Two-Year, Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to assess the efficacy and safety of Lampalizumab eye injections vs sham treatment. For patients with geographic atrophy secondary to dry age-related macular degeneration. This study includes an open-label extension trial called “OMASPECT” that all patients who complete the trial are eligible for. The open label trial allows for continued treatment, eliminating the sham injections and instead replacing with the investigation drug Lampalizumab for all patients.
FOVISTA | Protocol: OPH1004
A Two-Year, Phase III, Randomized, Double-masked, Controlled trial to establish the safety and efficacy of Fovista (Anti PDGF-B Pegylated Aptamer) eye injections in combination with either Avastin every four weeks or Eylea every eight weeks, compared to Avastin or Eylea monotherapy. For subjects with subfoveal neovascular age-related macular degeneration.
SCI FLUOR AVENUE | Protocol: SFO1066-C-002
An 8-Week Phase 1/II, Randomized, Multi-Dose, Double-Masked, Multicenter, Two-Dose study comparing the safety, tolerability, and efficacy of SFO1066-C-002, administered as a twice per day eye drop. For subjects with chorodial neovascularization secondary to age-related macular degeneration, washout period acceptable for patients previously treated with intraocular injections.