Research and Clinical Trials from
Charles Retina Institute

Research and Clinical Trials from
Charles Retina Institute

Charles Retina Institute offers a gateway to the frontiers of research and development in the field of retinal care. Pharmaceutial and surgical companies turn to our physicians to serve as primary investigators for their studies in the development of treatments for ocular conditions including macular degeneration, diabetic retinopathy, ocular occlusive diseases, and genetic therapies.

Within the framework of our institute, we have an independent research department that allows us to screen patients for immediate consideration into a multitude of new and innovative therapeutic studies. Patients meeting the required criteria can be enrolled within their first visit.

Current Studies

Diabetic Macular Edema

Novartis CRTH258B2301 Kestrel (active, enrollment closed)

A Two-Year, Three-Arm, Randomized, Double-Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab versus Aflibercept in Adult Patients with Visual Impairment due to Diabetic Macular Edema (KESTREL)

Opthea OPT-302-1003- (active enrollment, closed)

A Phase 1b/2a Study of OPT-302 in Combination with Aflibercept for Persistent Central-Involved Diabetic Macular Edema (OPTHEA)

Novartis CRTH258B2305 Kingfisher (active, enrolling)

A 12-Month, Two-Arm, Randomized, Double-Masked, Multicenter Phase III Study Assessing the Efficacy and Safety of Brolucizumab every 4 weeks versus Aflibercept every 4 weeks in Adult Patients with Visual Impairment due to Diabetic Macular Edema (KINGFISHER)

Genentech GR40349 Yosemite (active, enrollment closed)

A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients with Diabetic Macular Edema (YOSEMITE)

Genentech GR40550 Pagoda- Port Delivery System (pending activation, enrolling soon)

A Phase III, Multicenter, Randomized, Visual Assessor-Masked, Active Comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System with Ranibizumab in Patients with Diabetic Macular Edema (PAGODA)

Upcoming:

Regeneron VGFTe-HD-DME-1934/Regeneron DME 1934

A Randomized, Double-Masked, Active-Controlled Phase II/III Study of the Efficacy and Safety of High Dose Aflibercept in Patient with Diabetic Macular Edema

Wet Age-Related Macular Degeneration

Genentech GR40549 Portal (active, enrollment closed)

A Phase III, Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Tolerability of the Port Delivery System for Ranibizumab in Patients with Neovascular Age-Related Macular Degeneration Who Have Completed a Genentech Sponsored Study (PORTAL)

REGENXBIO RGX-314-5101/RGX-314-001 (active, enrollment closed)

A Phase I/IIa, Open-Label, Multiple-Cohort, Dose-Escalation Study to Evaluate the Safety and Tolerability of Gene Therapy with RGX-314 in Subjects with Neovascular AMD (nAMD)

Genentech GR40306 Tenaya– Wet AMD, treatment naive (active, enrollment closed)

A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients with Neovascular Age-Related Macular Degeneration (TENAYA)

Novartis CRTH258AUS04 Merlin (active, enrollment closed)

A Multicenter, Randomized, Double-Masked Phase IIIa Study to Assess the Safety and Efficacy of Brolucizumab 6 mg every 4 Weeks Compared to Aflibercept 2 mg every weeks in Patients with Neovascular Age-Related Macular Degeneration (nAMD) with Persistent Retinal Fluid (MERLIN)

Outlook Therapeutics ONS-5010-002 Norse 2 (active, enrolling)

A Clinical Effectiveness, Multicenter, Randomized, Double-Masked, Controlled Study of the Efficacy and Safety of ONS-5010 in Subject with Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD) (NORSE 2)

Novartis Talon (pending activation, enrolling soon)

A 64-week, Two-arm, Randomized, Double-Masked, Multicenter, Phase IIIb Study Assessing the Efficacy and Safety of Brolucizumab 6 mg Compared to Aflibercept 2 mg in a Treat-to-Control Regimen in Patients with Neovascular Age-Related Macular Degeneration (TALON)

Dry Age-Related Macular Degeneration

Genentech GR40973 Gallego (active, enrolling)

A Phase II, Multicenter, Randomized, Single-Masked, Sham-Controlled Study to Assess Safety, Tolerability, and Efficacy of Intravitreal Injections of FHTR2163 in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration (GALLEGO)

Retinal Vein Occlusion

Novartis CRTH258C2302 Raven CRVO (active, enrolling)

An Eighteen-Month, Two-Arm, Randomized, Double- Masked, Multicenter, Phase III Study Assessing the

Efficacy and Safety of Brolucizumab versus Aflibercept in Adult Patients with Visual Impairment due to Macular Edema secondary to Central Retinal Vein Occlusion (RAVEN)

Other

Retrophin 018CTXX15001 (active, enrolling)

An Observational, Multicenter Study of the Prevalence of Cerebrotendinous Xanthomatosis (CTX) in

Patient Populations Diagnosed with Early-Onset Idiopathic Bilateral Cataracts (RETROPHIN)

For additional information, please contact our study coordinator Melanie Woods at
(901) 767-4499 or at mwoods@charlesretina.com.