CLINICAL TRIALS CURRENTLY CONDUCTED AT RGW

Wet Macular Degeneration

CANDELA (Sponsor: Regeneron Pharmaceuticals)
2020-present

Clinical Trial Protocol Number: VGFTe (HD)-AMD-1905

A Randomized, Single-Masked, Active-Controlled Phase 2 Study of the Safety, Tolerability, and Efficacy of Repeated Doses of High-Dose Aflibercept in Patients with Neovascular Age-Related Macular Degeneration.

ARCHWAY (Sponsor: F. Hoffmann-La Roche Ltd.) 2018-present

Clinical Trial Protocol Number: GR40548

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 Neovascular Age-Related Macular Degeneration.

MERLIN (Sponsor: Novartis Pharmaceuticals Corp.) 2019-present

Clinical Trial Protocol Number: CRTH258AUS04

A Multicenter, Randomized, Double-Masked Phase 3a Study To Assess The Safety And Efficacy Of Brolucizumab 6mg Q4 weeks Compared To Aflibercept 2mg Q4 weeks In Patients With Neovascular Age-Related Macular Degeneration With Persistent Retinal Fluid.

PORTAL (Sponsor: F. Hoffmann-La Roche Ltd.) 2018-present

Clinical Trial Protocol Number: GR40549

A Multicenter, Open-Label Extension Study To Evaluate The Long-Term Safety And Tolerability Of The Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration.

TENAYA (Sponsor: F. Hoffmann-La Roche Ltd.) 2018-present

Clinical Trial Protocol Number: GR40306

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.

Wet AMD

SAMSUNG SB-15 (Sponsor: Samsung Bioepis Co., Ltd.)
2020-Present

Clinical Trial Protocol Number: SB15

A Phase III Randomised, Double-masked, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity between SB15 (proposed aflibercept biosimilar) and Eylea® in Subjects with Neovascular Age-related Macular Degeneration

Dry Macular Degeneration

DERBY and OAKS (Sponsor: Apellis Pharmaceuticals) 2018-present

Clinical Trial Protocol Numbers: APL-303 and APL-304

A Phase III, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy with Sham Injections in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD).

SAGA (Sponsor: Alkeus Pharmaceuticals, Inc.) 2018-present

Clinical Trial Protocol Number: ALK-001

A Phase 2/3 Multicenter, Randomized, Double-Masked, Parallel-Group, Placebo-Controlled Study To Investigate The Safety, Pharmacokinetics, Tolerability, And Efficacy Of ALK-001 In Geographic Atrophy Secondary To Age-Related Macular Degeneration.

Gather2 (Sponsor: IVERIC Bio)
2020-Present

Clinical Trial Protocol Number: ISEE2008

A PHASE 3 MULTICENTER, RANDOMIZED, DOUBLE-MASKED, SHAMCONTROLLED, CLINICAL TRIAL TO ASSESS THE SAFETY AND EFFICACY OF INTRAVITREAL ADMINISTRATION OF ZIMURA™, (COMPLEMENT C5 INHIBITOR) IN PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO DRY AGE-RELATED MACULAR DEGENERATION

Gallego (Sponsor: Genentech, Inc.)
2019-Present

Clinical Trial Protocol Number: GR40973

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

Diabetic Macular Edema

YOSEMITE (Sponsor: F. Hoffmann-La Roche Ltd) 2018-present

Clinical Trial Protocol Number: GR40349

A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study To Evaluate The Efficacy And Safety Of RO6867461 In Patients With Diabetic Macular Edema.

PAGODA (Sponsor: F. Hoffmann-La Roche Ltd) 2018-present

Clinical Trial Protocol Number: GR40550

A Phase II, 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.

Uveitis

LUMINA (Sponsor: Santen Pharmaceutical Co., Ltd) 2019-Present

Clinical Trial Protocol Number: 010906IN

This Trial Is A Randomized, Double-Blinded, Parallel-Group, Placebo-Controlled Trial To Assess The Long-Term Effects Of Treatment With Semaglutide Compared To Placebo, Both Added To Standard-Of-Care, On Diabetic Retinopathy Development And Progression In Subjects With Type 2 Diabetes.

Diabetic Retinopathy

FOCUS (Sponsor: Novo Nordisk) 2019-present

Clinical Trial Protocol Number: NN9535-4352

This Trial Is A Randomized, Double-Blinded, Parallel-Group, Placebo-Controlled Trial To Assess The Long-Term Effects Of Treatment With Semaglutide Compared To Placebo, Both Added To Standard-Of-Care, On Diabetic Retinopathy Development And Progression In Subjects With Type 2 Diabetes.

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