Diabetic Macular Edema (DME)

Sponsor - Genentech (Recruitment/Not Yet Open)

Study: ELEVATUM ML43435
A PHASE IV, MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO INVESTIGATE FARICIMAB (RO6867461) TREATMENT RESPONSE IN TREATMENT-NAÏVE, UNDERREPRESENTED PATIENTS WITH DIABETIC MACULAR EDEMA
https://clinicaltrials.gov/ct2/show/NCT05224102?term=elevatum&draw=2&rank=1

Sponsor - Alimera Sciences (Open to Enrollment)

Study: NEW DAY 01-20-005
A Randomized, Masked, Controlled Study of Intravitreal ILUVIEN Implant as Baseline Therapy in Patients with Early Diabetic Macular Edema (DME)
https://clinicaltrials.gov/ct2/show/NCT04469595?term=NEW+DAY&draw=2&rank=1

Sponsor - Oculis (Open to Enrollment)

Study: DIAMOND DX219
A Phase 2/3 Pivotal, Double-Masked, Randomized, 2-stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema
https://clinicaltrials.gov/ct2/show/NCT05066997?term=DX219&draw=2&rank=1

Sponsor - Kodiak Sciences, Inc. (Closed to Enrollment)

Study: GLEAM KS301P104
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 (DME)
https://clinicaltrials.gov/ct2/show/NCT04611152?term=GLEAM&draw=2&rank=3


Sponsor – Genentech (Closed to Enrollment) 

Study: PAGODA GR40550 
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)
https://clinicaltrials.gov/ct2/show/NCT04108156?term=PAGODA&draw=2&rank=1


Sponsor - Bayer/Regeneron (Closed to Enrollment)

Study: PHOTON VGFTe-HD-DME-1934
A RANDOMIZED, DOUBLE-MASKED, ACTIVE-CONTROLLED PHASE 2/3 STUDY OF THE EFFICACY AND SAFETY OF HIGH-DOSE AFLIBERCEPT IN PATIENTS WITH DIABETIC MACULAR EDEMA
https://clinicaltrials.gov/ct2/show/NCT04429503?term=Regeneron+PHOTON&draw=2&rank=1


Sponsor - F Hoffmann-La Roche Ltd.  (Closed to Enrollment)

Study: RHONE-X GR41987 
A MULTICENTER, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF FARICIMAB IN PATIENTS WITH DIABETIC MACULAR EDEMA
https://clinicaltrials.gov/ct2/show/NCT04432831?term=RHONE-X&draw=2&rank=1

Previous Diabetic Macular Edema (DME) Studies:

2019 - 2021
Sponsor - Novartis
Study: KINGFISHER
A 12-Month, 2-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
https://clinicaltrials.gov/ct2/show/NCT03917472?term=kingfisher&rank=3

2018 - 2021
Sponsor - Genentech/Roche
Study: RHINE
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 (RHINE)
https://clinicaltrials.gov/ct2/show/NCT03622593?term=RHINE&rank=1

Principal Investigator: 2019 - 2019

Sponsor: Thrombogenics
Study: N/A
A PHASE 1, OPEN-LABEL, MULTICENTER, DOSE ESCALATION STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF A SINGLE INTRAVITREAL INJECTION OF THR-687 FOR THE TREATMENT OF DIABETIC MACULAR EDEMA (DME)
https://clinicaltrials.gov/ct2/show/NCT03666923?term=THR-687&rank=1

Principal Investigator: 2016 - 2017
Sponsor: Genentech/Roche
Study: BOULEVARD
A MULTIPLE-CENTER, MULTIPLE-DOSE, RANDOMZED, ACTIVE COMPARATOR-CONTROLLED, DOUBLE-MASKED, PARALLEL GROUP, 28-WEEK STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF R06867461 ADMINISTERED INTRAVITREALLY IN PATIENTS WITH DIABETIC MACULAR EDEMA
https://clinicaltrials.gov/ct2/show/NCT02699450?term=BP30099&rank=1

Principal Investigator: 2016 - 2017
Sponsor: Regeneron
Study: RUBY
A RANDOMIZED, DOUBLE-MASKED, ACTIVE-CONTROLLED, PHASE 2 STUDY OF THE EFFICACY, SAFETY, AND TOLERABILITY OF REPEATED DOSES OF INTRAVITREAL REGN910-3 IN PATIENTS WITH DIABETIC MACULAR EDEMA
https://clinicaltrials.gov/ct2/show/NCT02712008?term=RUBY&rank=3

Sub-Investigator, 2008 - 2010
A 26-Week, Open-Label Study to Assess the Safety and Efficacy of 700µg Dexamethasone Posterior Segment Drug Delivery System Applicator System in the Treatment of Vitrectomized Subjects with Diabetic Macular Edema

Sub-Investigator, 2008 - 2010
A Phase 2, Randomized, Double-Masked, Placebo-Controlled, Dose-Ranging Clinical Study to Access the Safety and Efficacy of Subconjuctival Injections of Sirolimus in Patients with Diabetic Macular Edema Secondary to Diabetic Retinopathy

Sub-Investigator, 2008 - 2010
A 52-Week, Masked, Multicenter, Randomized, Controlled Trial (With Up To 13 Weeks Additional Follow-up) to Assess the Safety and Efficacy of 700µg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System in Combination with Laser Photocoagulation Compared with Laser Photocoagulation Alone in the Treatment of Subjects With Diffuse Diabetic Macular Edema (DME)

Sub-Investigator, 2007 - 2012 
RISE - A Phase 3, Double-Masked, Multicenter, Randomized, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab Injection in Subjects with Clinically Significant Macular Edema with Center Involvement Secondary to Diabetes Mellitus

Sub-Investigator, 2007 - 2011 
An Open Label Pharmacokinetic and Efficacy Study of 0.5µg/day and 0.2µg/day Flucinolone Acetonide Intravitreal Inserts in Subjects with Diabetic Macular Edema

Sub-Investigator, 2006 - 2011
FAME - A Randomized, Double-Masked, Parallel Group, Multi-center, Dose-Finding Comparison of the Safety and Efficacy of ASI-001A 0.5µg/day and ASI-001B .02µg/day Fluocinolone Acetonide Intravitreal Inserts to Sham Injection in Subjects with Diabetic Macular Edema

Sub-Investigator, 2003
Reduction in the Occurrence of Center-Treatment Diabetic Macular Edema.