The team of doctors at Cascade Medical Research (CMRI) are clinical-scientists and are committed to providing the leading ophthalmological studies that offer tomorrow’s scientific promise of improved outcomes and vision, today.
Enrolling Studies:
PEAK/PINNACLE, A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI)
Objective: To evaluate the efficacy of KSI-101 compared to sham.
NCT06990399 (PEAK) NCT06996080 (PINNACLE)
Sponsor: Kodiak Sciences
Principal Investigator: Robert Beardsley, MD
Lead Study Coordinator: Lexi Price-Breeze
BAROLO, A Randomized, Double-masked, Multi-center, 3-Arm Pivotal Phase 2/3 Study to Evaluate the Efficacy and Safety of Intravitreal EYE103 Compared with Intravitreal ranibizumab (0.5mg) in Participants with Diabetic Macular Edema (DME)
Objective: To demonstrate that EYE103 (0.5 mg or 0.8 mg) is non-inferior to ranibizumab 0.5 mg
NCT06957080
Sponsor: EyeBiotech
Principal Investigator: Allan Hunter, MD
Lead Study Coordinator: Lexi Price-Breeze
K8, Evaluation of K8 in subjects with geographic atrophy (GA)
Objective: This study will determine safety and efficacy of intravitreal injections of K8 in subjects with advanced non-exudative AMD.
NCT06164587
Sponsor: Inflammasome Therapeutics
Principal Investigator: Allan Hunter, MD
Lead Study Coordinator: Liz Carskadon Bale
Protocol AF, Fenofibrate for Prevention of DR Worsening
Objective: 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 eyes with mild to moderately severe non-proliferative DR (NPDR) and no CI-DME at baseline.
NCT04661358
Sponsor: Diabetic Retinopathy Clinical Research Network
Principal Investigator: Allan Hunter, MD
Lead Study Coordinator: Lexi Price-Breeze
Protocol AM, Randomized Trial Comparing Immediate versus Deferred Surgery for Symptomatic Epiretinal Membranes
Objective: Compare visual acuity outcomes at 36 months between eyes randomized to immediate versus deferred surgery.
NCT05145491
Sponsor: Diabetic Retinopathy Clinical Research Network
Principal Investigator: Allan Hunter, MD
Lead Study Coordinator: Liz Carskadon Bale
Protocol AO, Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD
Objective: Determine if Home OCT-guided treatment results in better visual acuity outcomesand/or 2) fewer number of injections over 104 weeks compared with treat and extend 204 (T&E)
NCT05904028
Sponsor: Diabetic Retinopathy Clinical Research Network
Principal Investigator: John Karth, MD
Lead Study Coordinator: Lexi Price-Breeze
PXL Platinum 330 System, Corneal Collagen Cross-Linking in Eyes with Corneal thinning position
Objective: To determine the safety and effectiveness of PXL Platinum 330 in treating corneal thinning conditions.
NCT03918408
Sponsors: Pacific Clear Vision Institute
Principal Investigator: Bala Ambati, MD, PhD, MBA
SIENNA, A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy (GA)
Objective: To evaluate the effect of systemic C5 inhibition on GA lesion growth over 52 weeks
NCT06541704
Sponsor: Regeneron Pharmaceuticals
Principal Investigator: Allan Hunter, MD
Lead Study Coordinator: Lexi Price-Breeze
THAMES, A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7446603 Administered Alone or in Combination With Aflibercept or Faricimab in Patients With Diabetic Macular Edema (DME)
Objective: This study will evaluate the safety, pharmacokinetics, and activity of RO7446603 in patients with diabetic macular edema (DME).
NCT06850922
Sponsor: Genentech, Inc.
Principal Investigator: Allan Hunter, MD
Lead Study Coordinator: Liz Carskadon Bale
Active Studies:
LUCIA, A 2-year Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Wet AMD
Objective: To comparing the efficacy of EYP-1901 against Aflibercept.
NCT06683742
Sponsor: EyePoint Pharmaceuticals
Principal Investigator: Allan Hunter, MD
Lead Study Coordinator: Lexi Price-Breeze
DAYBREAK, A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)
Objective: To evaluate the efficacy of tarcocimab-ted 5 mg compared to aflibercept 2 mg
NCT06556368
Sponsor: Kodiak Sciences
Principal Investigator: Allan Hunter, MD
Lead Study Coordinator: Liz Carskadon Bale
APEX, An Open Label, Multicenter Platform Study on the Safety, Tolerability, Bioactivity, and Pharmacokinetics of Multiple Intravitreal Therapies in Retinal Diseases (DME/MESI)
Objective: To evaluate the ocular and systemic safety and tolerability of intravitreal KSI-101.
NCT N/A
Sponsor: Kodiak Sciences
Principal Investigator: Allan Hunter, MD
Lead Study Coordinator: Liz Carskadon Bale
ARCHER II, A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of ANX007 in Participants With Geographic Atrophy (GA)
Objective: To evaluate efficacy of intravitreal (IVT) injections of ANX007
NCT06510816
Sponsor: Annexon, Inc
Principal Investigator: Allan Hunter, MD
Lead Study Coordinator: Liz Carskadon Bale
GLOW2, A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared with Sham Treatment in Participants with Moderately Severe to Severe Non-proliferative Diabetic Retinopathy (NPDR)
Objective: To demonstrate that tarcocimab 5 mg is superior to sham treatment
NCT06270836
Sponsor: Kodiak Sciences
Principal Investigator: Robert Beardsley, MD
Lead Study Coordinator: Lexi Price-Breeze
JADE, A Phase 1b Study to Assess the Safety, Tolerability,
Pharmacokinetics, and Exploratory Efficacy of Intravitreal OLN324 (wAMD and DME)
Objective: To assess the safety and tolerability of multiple
unilateral intravitreal injections of OLN324
(40 mg/mL) 2 mg and 4 mg.
NCT N/A
Sponsor: Ollin Biosciences, Inc.
Principal Investigator: Allan Hunter, MD
Lead Study Coordinator: Liz Carskadon Bale
PARASOL, A Study to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Objective: To evaluate change in geographic atrophy (GA) lesion growth of eyes treated with JNJ-81201887 compared to sham control.
NCT05811351
Sponsor: Janssen Pharmaceuticals
Principal Investigator: Allan Hunter, MD
Lead Study Coordinator: Liz Carskadon Bale
BRUNELLO, A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) (DME)
Objective: To demonstrate that EYE103 (0.5 mg or 0.8 mg) is non-inferior to ranibizumab 0.5 mg
NCT06571045
Sponsor: Eyebiotech
Principal Investigator: Allan Hunter, MD
Lead Study Coordinator: Liz Carskadon Bale
Closed Studies:
A study to Evaluate the efficacy, durability & safety of KSI-301 vs. Aflibercept in patients with Macular Edema due to Retinal Veil Occlusion (RVO)
NCT04592419
Sponsor: Kodiak Sciences Inc.
Principal Investigator: Allan Hunter, MD
A Study of NGM in Participants with Geographic Atrophy
NCT04465955
Sponsor: NGM Biopharmaceuticals, Inc
Principal Investigator: Allan Hunter, MD
A Phase 3 study of intravitreal OPT-302 in combination with aflibercept, compared with aflibercept alone, in participants with Neovascular Age-related Macular Degeneration (AMD)
NCT04757636
Sponsor: Opthea Limited
Principal Investigator: Allan Hunter, MD
A Phase III, multicenter, randomized, double masked, active comparator-controlled study to evaluate the efficacy and safety of faricimab in patients with macular edema secondary to central retinal or hemiretinal vein occlusion (CRVO/HRVO)
NCT04740931
Sponsor: Genentech, Inc.
Principal Investigator: Allan Hunter, MD
A study to Evaluate the efficacy & safety of Brolucizumab vs. Panretinal Photocoagulation laser in patient with Proliferative Diabetic Retinopathy (PDR)
NCT04278417
Sponsor: Novartis Research Development
Principal Investigator: Allan Hunter, MD
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 Neovascular (Wet) Age-related Macular Degeneration (wAMD)
NCT04964089
Sponsor: Kodiak Sciences Inc.
Principal Investigator: Allan Hunter, MD
A study to Evaluate the efficacy and safety of KSI-301 (anti-VEGF Antibody Biopolymer Conjugate) vs. Aflibercept in patients with Neovascular Wet AMD
NCT04049266
Sponsor: Kodiak Sciences Inc.
Principal Investigator: Allan Hunter, MD
OTT166-201 A Phase 2 Randomized, Double-Masked, Vehicle-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of OTT166 Ophthalmic Solution in the Treatment of Diabetic Retinopathy (DR)
NCT05409235
Sponsor: OcuTerra Therapeutics
Principal Investigator: Allan Hunter, MD
FYB201-C3-02
An Open-Label, Multi-Center, Single-Arm study to evaluate the ocular safety and usability of FYB201 Pre-filled Syringe (PFS)
NCT To be determined
Sponsor: Formycon
Principal Investigator: Allan Hunter, MD
A study to Evaluate the efficacy, durability, and safety of KSI-301 vs. Aflibercept in patients with Diabetic Macular Edema (DME)
NCT04964089
Sponsor: Kodiak Sciences Inc.
Principal Investigator: Allan Hunter, MD
A Prospective, Randomized, Double-masked, Sham-controlled, Multicenter, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Participants with Moderately Severe to Severe Non-proliferative Diabetic Retinopathy (NPDR)
NCT05066230
Sponsor: Kodiak Sciences Inc.
Principal Investigator: Robert Beardsley, MD
This study will evaluate the safety, pharmacokinetics, and activity of RO7446603 in patients with diabetic macular edema (DME).
NCT06850922
Sponsor: Genentech, Inc
Principal Investigator: Allan Hunter, MD
A Phase III, Multicenter, Sham-controlled, Randomized, double-masked study assessing the efficacy and safety of intravitreal injections of 440 µg DE-109 for the treatments of active, non-infectious uveitis of the Posterior Segment of the eye.
NCT03711929
Sponsor: Santen Inc.
Principal Investigator: Allan Hunter, MD
This proof of concept dose-finding study is designed to evaluate the efficacy, safety, and pharmacokinetics (PK) of danicopan in patients with GA secondary to AMD.
NCT05019521
Sponsor: Alexion Pharmaceuticals
Principal Investigator: Allan Hunter, MD
Efficacy and Safety Trial of Conbercept Intravitreal injection for Neovascular Age-related Macular Degeneration
NCT03630952
Sponsors: Chengdu Kanghong Biotech Co., Ltd.
Principal Investigator: Allan Hunter, MD
Intravitreous Aflibercept vs. Intravitreous Bevacizumab with Deferred Aflibercept for Central-Involved Diabetic Macular Edema
NCT03321513
Sponsor: Diabetic Retinopathy Clinical Research Network
Principal Investigator: Allan Hunter, MD
Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion (RAPTOR)
NCT03802630
Sponsor: Novartis Pharmaceuticals
Principal Investigator: Allan Hunter, MD
Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion (RAVEN)
NCT03810313
Sponsor: Novartis Pharmaceuticals
Principal Investigator: Allan Hunter, MD
A Randomized, Double-Masked, Placebo-Controlled, Parallel-Arm Study to Evaluate the Efficacy and Safety of RZ402 in Participants with Diabetic Macular Edema (DME)
NCT05712720
Sponsor: Rezolute Bio
Principal Investigator: Allan Hunter, MD
To compare the safety and efficacy of RGN-259 to placebo for the treatment of Neurotrophic Keratopathy (NK)
NCT05555589
Sponsor: ReGenTree, LLC
Principal Investigator: Joseph Mando, MD
A study to compare SCD411 and Eylea in subjects with Neovascular Wet Age-related Macular Degeneration (AMD)
NCT04480463
Sponsor: Sam Chun Dang Pharma. Co. Ltd
Principal Investigator: Allan Hunter, MD
A study to assess the efficacy and safety of Brolucizumab compared to Aflibercept in patients with Neovascular Wet AMD
NCT04005352
Sponsor: Novartis Research Development
Principal Investigator: Allan Hunter, MD