Title: PROSPECTIVE, RANDOMIZED PHASE 3 STUDY COMPARING TWO MODELS OF A TRAVOPROST INTRAOCULAR IMPLANT TO TIMOLOL MALEATE OPHTHALMIC SOLUTION, USP, 0.5%
Sponsor: GLAUKOS CORPORATION
Purpose: To compare the safety and initial efficacy of intraocular implants containing travoprost at two different elution rates versus Timolol Maleate Ophthalmic Solution, USP, 0.5% (timolol) in reducing elevated intraocular pressure in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Title: Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
Sponsor: Allergan
Purpose: This study will evaluate the intraocular pressure-lowering effect and safety of Bimatoprost SR compared with selective laser trabeculoplasty in patients with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication.
Title: A Multicenter, Open-Label Extension Study To Evaluate The Long-Term Safety And Tolerability Of Faricimab In Patients With Diabetic Macular Edema (Rhone-X)
SPONSOR: F. HOFFMANN-LA ROCHE LTD
Objective: This long-term extension (LTE) study will evaluate the long-term safety, tolerability, and efficacy of intravitreal (IVT) faricimab in patients with diabetic macular edema who have completed either of the Phase III (GR40349 or GR40398) studies. Additional assessments relating to pharmacokinetics, immunogenicity, and biomarkers will be performed.
Title: A Multicenter, Open-Label Extension Study To Evaluate The Long-Term Safety And Tolerability Of Faricimab In Patients With Neovascular Age-Related Macular Degeneration (Avonelle-X)
SPONSOR: F. HOFFMANN-LA ROCHE LTD
Objective: This study will evaluate the long-term safety and tolerability of intravitreal (IVT) faricimab in patients with neovascular age-related macular degeneration (nAMD) who have completed either of the Phase III (GR40306 or GR40844) studies. Additional assessments relating to efficacy, pharmacokinetics, immunogenicity, and biomarkers will be performed.
Title: A PHASE III, MULTICENTER, RANDOMIZED STUDY OF THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF THE PORT DELIVERY SYSTEM WITH RANIBIZUMAB IN PATIENTS WITH DIABETIC RETINOPATHY (PAVILION)
Sponsor: F. Hoffman-La Roche Ltd.
Purpose: To evaluate the efficacy, safety, and pharmacokinetics of Ranibizumab delivered via the Port Delivery System in patients with Diabetic Retinopathy.
Title: 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. (GR40550 PAGODA)
Sponsor: F. Hoffman-La Roche Ltd.
Purpose: Evaluate the efficacy, safety, and pharmacokinetics of the Port Delivery System with Ranibizumab in patients with Diabetic Macular Edema (DME).
Title: PROSPECTIVE, RANDOMIZED PHASE 3 STUDY COMPARING TWO MODELS OF A TRAVOPROST INTRAOCULAR IMPLANT TO TIMOLOL MALEATE OPHTHALMIC SOLUTION, USP, 0.5%
Sponsor: GLAUKOS CORPORATION
Purpose: To compare the safety and initial efficacy of intraocular implants containing travoprost at two different elution rates versus Timolol Maleate Ophthalmic Solution, USP, 0.5% (timolol) in reducing elevated intraocular pressure in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Title: Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
Sponsor: Allergan
Purpose: This study will evaluate the intraocular pressure-lowering effect and safety of Bimatoprost SR compared with selective laser trabeculoplasty in patients with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication.
Title: 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 Branch Retinal Vein Occlusion (Balaton)
SPONSOR: F. HOFFMANN-LA ROCHE LTD
Objective: Objective: This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab compared with aflibercept in patients with macular edema due to branch retinal vein occlusion (BRVO) up to the primary endpoint at Week 24. Efficacy, safety, and pharmacokinetics of faricimab administered according to the personalized treatment interval (PTI) dosing regimen (i.e., from every 4 weeks [Q4W] to every 16 weeks [Q16W]) will be assessed during the study period from Weeks 24 to 72.
Title: 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 Hemi Retinal Vein Occlusion (Comino)
SPONSOR: F. HOFFMANN-LA ROCHE LTD
Objective: This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab compared with aflibercept in patients with macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO) up to the primary endpoint at Week 24. Efficacy, safety, and pharmacokinetics of faricimab administered according to the personalized treatment interval (PTI) dosing regimen (i.e., from every 4 weeks [Q4W] to every 16 weeks [Q16W]) will be assessed during the study period from Weeks 24 to 72.
Title: A 52-Week Multicenter, Randomized, Double-Masked, 2-Arm Parallel Study To Compare Efficacy, Safety and Immunogenicity Of SOK583A To Eylea®, Administered Intravitreally, In Patients With Neovascular Age-Related Macular Degeneration (MyLight)
SPONSOR: SANDOZ
Objective: To demonstrate similar efficacy, safety and immunogenicity of SOK583A1 and Eylea as per Eylea approved treatment regimen in patients with nAMD.
Title: A Longitudinal, Biomarker Study Of Anti-VEGF, to Explore the Relationship Between Aqueous Humor Composition And Multimodal Retinal Imaging In Neovascular Age-Related Macular Degeneration And Diabetic Macular Edema (Longitude)
SPONSOR: F. HOFFMANN-LA ROCHE LTD
Objective: This is an open-label, multicenter, non-randomized, two-cohort, biomarker study in treatment-naïve study eyes of 100 nAMD participants and treatment-naïve study eyes of 100 DME participants to explore the composition of AH and features of multimodal retinal imaging before and during a six-month treatment period with aflibercept.
Title: A Phase IIIb, Multicenter, Open-Label, Single-Arm Study Of The Efficacy And Safety Of The Port Delivery System With Ranibizumab In Patients With Neovascular Age-Related Macular Degeneration Previously Treated With Intravitreal Agents Other Than Ranibizumab (Belvedere)
SPONSOR: GENENTECH, INC
Objective: This study will evaluate the efficacy and safety of the Port Delivery System with ranibizumab (PDS) 100 mg/mL delivered every 24 weeks (Q24W) in patients with neovascular age-related macular degeneration (nAMD) previously treated with anti-VGEF agents other that Ranibizumab.
TITLE: (Gleam) 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)
SPONSOR: Kodiac Sciences, Inc.
Objective: This is a Phase 3, prospective, randomized, double-masked, two-arm, multi-center non-inferiority study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with treatment-naïve DME. The primary endpoint will be assessed at Year 1; additional secondary endpoints for efficacy will be assessed at Years 1 and 2.
TITLE: 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) (Daylight)
SPONSOR: Kodiac Sciences, Inc.
Purpose: This is a Phase 3, prospective, randomized, double-masked, two-arm, multi-center non-inferiority study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with visual impairment due to treatment-naïve neovascular (wet) age-related macular degeneration (wAMD). The primary endpoint will be assessed at Week 40; additional secondary endpoints for efficacy will be assessed by visit over time.