Hawaii Macula and Retina Institute Clinical Trials

Treatment options for wet-AMD and diabetic retinopathy are still being researched and studied.  Lucentis and Avastin have revolutionized the treatment of wet AMD and Diabetic Retinopathy and prior to 2006, the medication was only available through clinical trials.  In Hawaii, these medications were available as early as 2002 through our research center (almost 4 years before it became FDA approved) through various clinical trials.  Sometimes, research trials can provide additional treatment options, research is not an option for everyone so please talk to your doctors if you feel that you might be a candidate for a clinical trial.  All research conducted at our clinic is reviewed by an Institutional Review Board as required by the FDA.

Open Enrolling Trials

• ASCENT – A randomized, partially masked, controlled, phase 3 clinical study to evaluate the efficacy and safety of RGX-314 gene therapy in participants with neovascular age-related macular degeneration (Wet AMD)
• ATMOSPHERE – A randomized, partially masked, controlled, phase 2b/3 clinical study to evaluate the efficacy and safety of RGX-314 gene therapy in participants with neovascular age-related macular degeneration (Wet AMD)

Ongoing Trials

• BALATON – A phase 3, multicenter, randomized, double-masked, active comparator-controlled study to evaluate the efficacy and safety of faricimab in patients with macular edema secondary to branch retinal vein occlusion
• COMINO – A phase 3, multicenter, randomized, double-masked, active comparator-controlled study to evaluate the efficacy and safety of faricimab in patients with macular edema secondary to central of hemi retinal vein occlusion
• GLIMMER – A prospective, randomized, double-masked, active comparator-controlled, multi-center, two-arm, 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 diabetic macular edema
• SALUTARIS—Investigates the safety of the SMD-DA to deliver radiation therapy to treatment naïve wet AMD/polypoidal choroidal vasculopathy
• CLKA651X2202 – A randomized, active-controlled, patient and investigator-masked, multiple dose proof-of-concept study of intravitreal LKA651 in patients with diabetic macular edema
• PULSAR – A randomized, double-masked, active-controlled, phase 3 study of the efficacy and safety of high dose aflibercept in patients with treatment naïve wet AMD
• PHOTON – A randomized, double-masked, active-controlled, phase 3 study of the efficacy and safety of high dose aflibercept in patients with diabetic macular edema
• PAVILION – A phase 3, multicenter, randomized study of the efficacy, safety, and pharmacokinetics of the port deliver system with ranibizumab in patients with diabetic retinopathy
• RHONE-X – A multicenter, open-label extension study to evaluate the long-term safety and tolerability of faricimab in patients with diabetic macular edema
• GATHER2 – A phase 3, multicenter, randomized, double-masked, sham-controlled clinical trial to assess the safety and efficacy of intravitreal administration of Zimura (complement C5 inhibitor) in patients with geographic atrophy secondary to dry AMD
• AVONELLE-X – A multicenter, open-label extension study to evaluate the long-term safety and tolerability of faricimab in patients with neovascular age-related macular degeneration

Completed Trials

• KINGFISHER – Investigates the safety and efficacy of brolucizumab  every 4 weeks in patients with visual impairment due to diabetic macular edema.
• ALTISSIMO – Investigates the safety, tolerability, and efficacy of intravitreal depot formulation of sunitinib malate in patients with   wet AMD
• YOSEMITE—Investigates the safety and efficacy of faricimab in patients with diabetic macular edema
• MERLIN—Investigates the safety and efficacy of brolucizumab 6mg every 4 weeks in patients with wet AMD with persistent retinal fluid
• KESTREL—Investigates the safety and efficacy of brolucizumab versus aflibercept in patients with visual impairment due to diabetic macular edema
• PANDA—Investigates the efficacy and safety of conbercept intravitreal injection in patients with treatment naïve wet AMD
• LUCERNE – Investigates the safety and efficacy of faricimab in patients with treatment naive wet AMD
• OPH2003 – Assess the safety and efficacy of intravitreous administration of Zimura in subjects with geographic atrophy secondary to Dry AMD
• SB11 –  Evaluated the efficacy, safety, pharmacokinetics and immunogenicity between SB11 and Lucentis in subjects with Wet AMD
• SAPPHIRE-Evaluation of Suprachoroidal CLS-TA in Conjunction with Intravitreal Aflibercept in Patients with Retinal Vein Occlusions (Primary Investigator: James C. Lai, MD)
• OPH2006 – Evaluates the safety and efficacy of Zimura in combination with aflibercept in patients with polypoidal choroidal vasculopathy (Primary Investigator: Gregg T. Kokame, MD)
• HAWK-Evaluation of RTH258 in Patients with Treatment Naïve Wet-Age related Macular Degeneration (Primary Investigator:  Gregg T. Kokame, MD)
• CEDAR- Evaluation of Abicipar Pegol in Patients with Treatment Naïve Wet Age-related Macular Degeneration (Primary Investigator:  James C. Lai, MD)
• ARGUS II Post Approval Study of the ARGUS II Retinal Prosthesis System (Primary Investigator:  Gregg T. Kokame, MD)
• PALADIN- Safety assessment of IOP after treatment of Iluvien for DME (Primary Investigator: Gregg T. Kokame, MD)
• ONYX-Evaluation of REGN910-3 in Patients with Treatment Naive Wet-Age related Macular Degeneration (Primary Investigator: Gregg T. Kokame, MD)
• RUBY-Evaluation of REGN910-3 in Patients with Diabetic Macular Edema (Primary Investigator: Raymond Wee, MD)
• MAKO-Evaluation of Topical Squalamine for Treatment Naive Wet-Age related Macular Degeneration (Primary Investigator: Gregg T. Kokame, MD)
• OMASPECT: Open label Extension study evaluating Intravitreal Lampalizumab in Patients with Geographic Atrophy (Primary Investigator: Gregg T. Kokame, MD)