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NCT04108156 Clinical Trial

This Study Will Evaluate the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Participants With Diabetic Macular Edema Compared With Intravitreal Ranibizumab

Diabetic Macular Edema Clinical Trial

— Pagoda  

Official 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 (Pagoda)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04108156
Other study ID # GR40550
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date September 30, 2019
Est. completion date February 28, 2025

Study information
Verified date April 2024
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of the Port Delivery System with Ranibizumab (PDS) in Participants with Diabetic Macular Edema (DME) when treated every 24 weeks (Q24W) compared with intravitreal ranibizumab 0.5 mg every 4 weeks (Q4W).

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Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• PDS Implant Pre-Filled with 100 mg/mL Ranibizumab
Will be administered as per the schedule described in individual arm.
• Intravitreal Ranibizumab 0.5 mg Injection
Will be administered as per the schedule described in individual arm.
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Sponsors (1)
Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in BCVA score from baseline averaged over Weeks 60 and 64 as measured using the ETDRS chart in the efficacy population using a treatment policy strategy for all intercurrent events BCVA = Best-Corrected Visual Acuity
ETDRS = Early Treatment Diabetic Retinopathy Study
A vision score of 20/20 vision is considered normal. A score of 20/200 is considered being legally blind.		 Baseline to Week 64
Secondary Change in BCVA score from baseline averaged over Weeks 60 and 64 as measured with use of the ETDRS chart in the modified intent-to-treat (mITT) population using a treatment policy strategy for all intercurrent events ETDRS-DRSS = ETDRS Diabetic Retinopathy Severity Scale Baseline to Week 64
Secondary Change in BCVA score from baseline averaged over Weeks 60 and 64 as measured with use of the ETDRS chart in the mITT population using a hypothetical strategy for all intercurrent events Baseline to Week 64
Secondary Percentage of participants with a =2-step improvement from baseline on the ETDRS-DRSS at Week 64 in the efficacy population Baseline to Week 64
Secondary Percentage of participants with a =2-step improvement from baseline on the ETDRS-DRSS at Week 64 in the mITT population Baseline to Week 64
Secondary Change from baseline in BCVA as measured on the ETDRS chart over time Baseline up to Week 120
Secondary Percentage of participants who lose <15, <10, and <5 letters in BCVA from baseline over time Baseline up to Week 120
Secondary Percentage of participants who gain =15, =10, =5, =0 letters in BCVA from baseline over time Baseline up to Week 120
Secondary Percentage of participants with a BCVA Snellen equivalent of 20/40 or better over time Baseline up to Week 120
Secondary Percentage of participants with a BCVA Snellen equivalent of 20/200 or worse over time Baseline up to Week 120
Secondary Percentage of participants with a =2-step improvement from baseline on the ETDRS-DRSS over time Baseline up to Week 120
Secondary Percentage of participants with a =3-step improvement from baseline on the ETDRS-DRSS over time Baseline up to Week 120
Secondary Time to =2-step worsening from baseline on the ETDRS-DRSS Baseline up to Week 120
Secondary Time to =3-step worsening from baseline on the ETDRS-DRSS Baseline up to Week 120
Secondary Change from baseline in ETDRS-DRSS score over time Baseline up to Week 120
Secondary Change from baseline in CST as measured on SD-OCT over time Baseline up to Week 120
Secondary Change from baseline in total macular volume as measured on SD-OCT over time Baseline up to Week 120
Secondary Percentage of participants with absence of intraretinal fluid over time (intraretinal fluid as measured in the central 1 mm subfield) Baseline up to Week 120
Secondary Percentage of participants with absence of subretinal fluid over time (subretinal fluid as measured in the central 1 mm subfield) Baseline up to Week 120
Secondary Percentage of participants with absence of intraretinal fluid and subretinal fluid over time Baseline up to Week 120
Secondary Percentage of participants with absence DME (defined as CST =325 µm on SD-OCT) over time DME = diabetic macular edema Baseline up to Week 120
Secondary Time to PDR (defined as a score =60 on the ETDRS-DRSS) PDR = proliferative diabetic retinopathy Baseline up to Week 120
Secondary Percentage of participants who do not undergo supplemental treatment with intravitreal ranibizumab within each refill-exchange interval Baseline up to Week 120
Secondary Percentage of participants who report preferring PDS treatment compared with intravitreal ranibizumab treatment As measured by the PDS Patient Preference Questionnaire at Week 64 among patients in the PDS arm efficacy population, mITT population Baseline to Week 64
Secondary Percentage of participants who report preferring PDS treatment compared with intravitreal ranibizumab treatment, as measured by the PDS Patient Preference Questionnaire (PPPQ) at Week 64 Participants in in a subset of patients with bilateral disease who are simultaneously receiving ranibizumab via study eye PDS implant and fellow eye intravitreal injection Baseline to Week 64
Secondary Patient-reported vision-related functioning and health-related quality of life (HRQoL) among patients in both treatment arms, as measured by changes from baseline As measured by in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) composite score and Near Activities, Distance Activities, and Driving subscale scores , Baseline Week 48, Week 96
Secondary Patient-reported vision-related functioning and HRQoL, as measured by the proportion of patients with a = 4-point improvement from baseline in the NEI VFQ-25 composite score at Weeks 48 and 96 among patients in both treatment arms Baseline, Week 48, Week 96
Secondary Incidence and severity of ocular adverse events Baseline to Week 120
Secondary Incidence and severity of non-ocular adverse events Baseline up to Week 120
Secondary Incidence, severity, and duration of adverse events of special interest Baseline up to Week 120
Secondary Serum concentration of ranibizumab observed over time Baseline up to Week 120
Secondary PK parameter value area under the concentration- time curve over 24 weeks (AUC24W) Baseline to Week 24
Secondary Pharmacokinetic (PK) parameter maximum serum concentration (Cmax) Baseline up to Week 120
Secondary PK Parameter minimum serum concentration (Cmin) Baseline up to Week 120
Secondary Time of maximum observed serum concentration (Tmax) after PDS implant insertion Baseline up to Week 120
Secondary Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study Baseline up to Week 120
Secondary Prevalence of neutralizing antibodies at baseline and incidence of neutralizing antibodies during the study Baseline up to Week 120
Secondary Reported incidence of device deficiencies Baseline up to Week 120
Secondary Incidence and severity of ocular adverse events Baseline up to Week 120
Secondary Incidence, severity, and duration of ocular adverse events of special interest during the postoperative period (up to 37 days after initial implantation) and follow-up period (> 37 days after implantation surgery) Baseline up to Week 120
Secondary Incidence and severity of adverse device effects Baseline up to Week 120
Secondary Incidence, causality, severity, and duration of anticipated serious adverse device effects Baseline up to Week 120
See also
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Terminated NCT04603937 - A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) Phase 3
Terminated NCT04611152 - A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) Phase 3
Completed NCT02867735 - A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema Phase 1
Withdrawn NCT03629210 - Combination OZURDEX® & EyLea® vs. OZURDEX® Monotherapy in IncompLete-Responders wIth Diabetic Macular Edema Phase 2
Withdrawn NCT02842541 - Safety Study of Intravitreal EBI-031 Given as a Single or Repeat Injection to Subjects With Diabetic Macular Edema Phase 1
Completed NCT02221453 - Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide Phase 2
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Completed NCT02979665 - Changes to the Retina Following Anti-VEGF Treatments for Diabetic Macular Edema
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Completed NCT02088229 - Relating Retinal Structural and Functional Parameters to Visual Acuity in Eyes Undergoing Treatment for Diabetic Macular Edema N/A
Terminated NCT00779142 - Utility of Intravitreal Methotrexate in Diabetic Macular Edema Resistant to Conventional Therapies N/A
Completed NCT01171976 - Efficacy and Safety of Ranibizumab in Two "Treat and Extend" Treatment Algorithms Versus Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus Phase 3
Completed NCT00989989 - Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema Phase 3
Completed NCT00683176 - Effect of Choline Fenofibrate (SLV348) on Macular Edema Phase 2
Terminated NCT00768040 - Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema Phase 2
Completed NCT01259609 - Changes in Ciliary Body Thickness in Patients With Diabetic Macular Edema After Vitrectomy N/A
Active, not recruiting NCT00801450 - Intravitreal Injection Versus Sub-Tenon's Infusion of Triamcinolone Acetonide for Refractory Diabetic Macular Edema During Cataract Surgery Phase 1/Phase 2