Clinical Trials

CLINICAL TRIALS Currently CONDUCTED AT RGW:

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.

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).

EYLEA BIOSIMILAR (Sponsor: Mylan Inc. ) 2018-Present

Clinical Trial Protocol Number: MYL-1701P-3001

A Multi Center, Randomized, Double-Masked, Active-Controlled, Comparative Clinical Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects with Diabetic Macular Edema.

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

Clinical Trial Protocol Number: 010906IN

A Phase III, Multicenter, Sham-Controlled, Randomized, Double-Masked Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 µg of DE-109 for the treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye.

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 q4weeks compared to aflibercept 2mg q4 weeks in patients with neovascular Age-related Macular Degeneration with persistent retinal fluid.

PANORAMA (Sponsor: Regeneron Pharmaceuticals, Inc.) 2016-Present

Clinical Trial Protocol Number: VGFTe-OD-1411

A Phase 3, Double-Masked, Randomized study of the efficacy and safety of intravitreal Aflibercept Injection in patients with Moderately Severe to Severe Nonproliferative Diabetic Retinopathy.

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.

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.

SCORE2 LTF (Sponsor: National Eye Institute with Penn State University) 2014-present

Clinical Trial Protocol Number: SCORE2

Study of Comparative Treatments for Retinal Vein Occlusion 2 [SCORE2]: a multicenter, prospective, randomized non-inferiority trial of eyes with macular edema secondary to central retinal vein occlusion, comparing intravitreal bevacizumab every 4 weeks with intravitreal aflibercept every 4 weeks.

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.

ZIMURA (Sponsor: OPHTHOTECH CORP.) 2018- Present

Clinical Trial Protocol Number: OPH2003

A Phase 2b Randomized, Double Masked, Controlled trial to assess the safety and efficacy of Intravitreous administration of ZIMURA™ in subjects with Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration.

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