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Report for Clinical Trial NCT04108156

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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)

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).

NCT04108156 Diabetic Macular Edema
MeSH:Macular Edema Edema
HPO:Anasarca Cystoid macular edema Edema Macular edema

2 Interventions

Name: PDS Implant Pre-Filled with 100 mg/mL Ranibizumab

Description: Will be administered as per the schedule described in individual arm.
Type: Drug
Group Labels: 1

PDS Arm

Name: Intravitreal Ranibizumab 0.5 mg Injection

Description: Will be administered as per the schedule described in individual arm.
Type: Drug
Group Labels: 1

Intravitreal Arm


Primary Outcomes

Description: 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.

Measure: Change in BCVA score from baseline averaged over Weeks 60 and 64 as measured using the ETDRS chart

Time: Baseline to Week 64

Secondary Outcomes

Description: ETDRS-DRSS = ETDRS Diabetic Retinopathy Severity Scale

Measure: Percentage of participants with a ≥2-step improvement from baseline on the ETDRS-DRSS at Week 64

Time: Baseline to Week 64

Measure: Change from baseline in BCVA as measured on the ETDRS chart over time

Time: Baseline up to Week 120

Measure: Percentage of participants who lose <10, and <5 letters in BCVA from baseline over time

Time: Baseline up to Week 120

Measure: Percentage of participants who gain ≥15, ≥10, ≥5, ≥0 letters in BCVA from baseline over time

Time: Baseline up to Week 120

Measure: Percentage of participants with a BCVA Snellen equivalent of 20/40 or better over time

Time: Baseline up to Week 120

Measure: Percentage of participants with a BCVA Snellen equivalent of 20/200 or worse over time

Time: Baseline up to Week 120

Measure: Percentage of participants with a ≥3-step improvement from baseline on the ETDRS-DRSS at Week 64

Time: Baseline to Week 64

Measure: Percentage of participants with a ≥2-step improvement from baseline on the ETDRS-DRSS over time

Time: Baseline up to Week 120

Measure: Percentage of participants with a ≥3-step improvement from baseline on the ETDRS-DRSS over time

Time: Baseline up to Week 120

Measure: Percentage of participants with a ≥2-step worsening from baseline on the ETDRS-DRSS over time

Time: Baseline up to Week 120

Measure: Percentage of participants with a ≥3-step worsening from baseline on the ETDRS-DRSS over time

Time: Baseline up to Week 120

Measure: Change from baseline in ETDRS-DRSS score over time

Time: Baseline up to Week 120

Description: CST = central subfield thickness SD-OCT = spectral domain optical coherence tomography

Measure: Change from baseline in CST as measured on SD-OCT at Week 64

Time: Baseline to Week 64

Measure: Change from baseline in CST as measured on SD-OCT over time

Time: Baseline up to Week 120

Measure: Change from baseline in total macular volume as measured on SD-OCT over time

Time: Baseline up to Week 120

Description: DME = diabetic macular edema

Measure: Percentage of participants with DME (defined as CST ≥325 μm on SD-OCT) over time

Time: Baseline up to Week 120

Description: PDR = proliferative diabetic retinopathy

Measure: Percentage of participants with PDR (defined as a score ≥60 on the ETDRS-DRSS) over time

Time: Baseline up to Week 120

Measure: Incidence and severity of ocular adverse events

Time: Baseline to Week 120

Measure: Incidence and severity of non-ocular adverse events

Time: Baseline up to Week 120

Measure: Incidence, severity, and duration of adverse events of special interest

Time: Baseline up to Week 120

Measure: Incidence, severity, and duration of PDS-associated 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)

Time: Baseline up to Week 120

Measure: Serum concentration of ranibizumab observed over time

Time: Baseline up to Week 120

Measure: PK parameter value area under the concentration- time curve over 24 weeks (AUC24W)

Time: Baseline to Week 24

Measure: Pharmacokinetic (PK) parameter maximum serum concentration (Cmax)

Time: Baseline up to Week 120

Measure: PK Parameter minimum serum concentration (Cmin)

Time: Baseline up to Week 120

Measure: PK parameter half-life (t1/2) after PDS implant insertion

Time: Baseline up to Week 120

Measure: Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study

Time: Baseline up to Week 120

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 Q24W

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 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). --- Q24W ---



HPO Nodes


HPO:
HP:0000969: Edema
Genes 492
MEFV SLC40A1 RYR1 TLR3 IL2RG DYNC2H1 TET2 COQ8B HLA-A COQ2 ADAMTS3 NR1H4 KCTD1 TCF4 COL8A2 GPR101 IL2RA CTSA B2M TNFRSF1B MAP2K2 RRM2B DCLRE1C ABCC9 ACTB SCARB2 AHCY LYZ NEU1 IL12A CTRC FASLG SETD5 PTPRO IGSF3 ANTXR2 BUB1 OTULIN FLT4 OCRL CHD7 PLAA RANBP2 LACC1 IRAK1 MST1 PKLR GBA CPN1 RP9 CPS1 IL12A-AS1 SOX18 HADHA MAP2K1 ERAP1 PIK3CA CFI TP53 DNASE1L3 SMS HDAC8 REEP6 MFRP PIEZO1 UNC93B1 KCTD1 KLF1 KMT2A CCDC88A AKT1 PTPN22 RANBP2 KRAS AIP ALG9 LZTR1 FGFR3 SOS1 COL11A1 WDR35 UROS KIAA0586 KIT BCKDHA RIT1 SMAD4 VEGFC HGD TNFRSF1B RMRP GPC6 CAMTA1 TEK PLCE1 CHRNA1 F8 HELLPAR SPINK5 FGFR3 SPTB SGPL1 ANTXR1 RAF1 WDR60 CD46 EBP FAT4 GLE1 COL2A1 ACTA1 DSP MEFV POMP KCNQ2 IL2RA DUX4 CCBE1 HLA-DRB1 DNMT1 PTEN TP53 INHBA FGA IBA57 CHEK2 POLG2 NRAS TSC1 DHDDS NAGA GRIP1 NEB SMC1A EPB41 C1R ATN1 GBA ALB ANKH ADAMTS3 SLC25A4 SLCO2A1 NEK1 GLA GJC2 CDC42 PLD1 WDR34 NRL SLC26A2 RYR1 HAVCR2 MRPS22 ASAH1 HLA-DPA1 ACAT1 SPTA1 STAT4 NAXD PAX2 GLA LMOD3 GNPTAB COL2A1 TNFRSF1A IL1RN NRAS SLC25A13 BMP2 PHGDH LEMD3 LTBP4 HADHB PIEZO1 LAMA2 MVK ARHGEF18 FN1 GBA PTPN2 PTH1R PTPN11 KRT2 HMGCL FAT4 CDC42 LBR FRMD4A SLC4A1 IFT172 MAP2K1 INPPL1 TNFRSF1A GATA1 CARS2 PRPF31 SLC25A13 FIG4 ALG8 PSMB4 HBA2 BRAF NOD2 OTC GATA2 ACTN4 F12 KIAA1109 BMPR1A LIG4 AGGF1 RAG1 KCNN4 BCL6 PRPH2 KIF7 ASL SMCHD1 PTPN22 HPGD C1QA ELN CAMTA1 COL1A2 PMM2 BUB3 MRPS16 ANKRD55 CCR1 SLC35D1 PEX2 PSPH EPHB4 TRIP11 ERCC5 IL2RB FRMD4A TAPT1 TICAM1 HLA-DRB1 PIGA APOA1 ACAD9 SLC17A5 CEP57 PTPN22 RFC2 ERBB3 DIS3L2 NPHS2 ABCC6 CLCNKB CTLA4 PTPN2 CFTR KRAS PTPN11 ZEB1 HPGD FAT4 UBR1 CTLA4 PRTN3 GJC2 MKKS USP8 NEK9 SCN4A XYLT1 NLRC4 XYLT2 KRT13 SOX18 FGA KIF1A MIF MYO1E TGM1 PRF1 NAGA PTPN14 PMM2 ALPK3 SPINK1 HLA-DRB1 STAT4 LPIN2 SMC3 FOXC2 KLRC4 NOS3 TMPRSS15 SUMF1 MYBPC3 BCKDHB GUSB BRAF FRG1 LIMK1 PRKAG2 NLRP3 SERPING1 NAXE TBL2 RIT1 PDE6G KIF11 SLC29A3 SHANK3 POMGNT1 TWNK CHRND XPNPEP2 IL7R ZNHIT3 RASA2 ACAD9 RIN2 TCF4 GSN WNT7A HBA1 KIF11 NLRP3 ATP7B CDK5 PRPF8 SERPING1 BCL2 CCBE1 SMCHD1 SNX14 CHRNG SHANK3 RAD21 RRAS NOD2 SERPING1 CLIP2 FLT4 RELN PEX5 FSHR KRAS RIN2 NIPBL PSMB9 FECH COL2A1 CCN6 GYPC PLVAP TALDO1 FAS IGH ARHGDIA HLA-B CD28 ADAMTS2 BMPER BUB1B CTLA4 HLA-DPB1 DYSF CDAN1 CBL ADA EGFR VEGFC CPT2 FLNB TMEM260 C4A UBAC2 DHCR7 RDH5 RLBP1 CD28 TSC2 CD247 IKBKG IL23R FGG LMX1B RAG2 FOXC2 WDR35 SAMHD1 TUBB NAGA ZNHIT3 SOS2 RRAS2 POLG GNAQ RHO CD55 GBE1 RBM8A PRKAR1A SOX18 CYTB TLR4 NR2E3 SLC26A2 PDSS2 TRAF3 TRIP13 IL10 UBR1 CD247 IL6 RB1 PIGN GBA IL2RB RASGRP1 BSND CASP10 AIP ALG1 NDUFS4 STAT4 TPRKB NPHS1 GTF2I INPPL1 PLAA KLHL41 MYD88 TREX1 GUSB BTNL2 ASAH1 NUP107 HFE CDH11 CBL CLCNKA FGB ALG12 PTH1R GPR35 GATA2 PRKCD ANKRD55 APOE WDR35 LYST ARL3 TRIP11 FIG4 IFT80 BAZ1B PKLR FAS ABCC6 ABCC9 STAT4 ACTG1 KPTN FOXG1 SPP1 ABCC9 TBK1 OSGEP COL1A1 PDSS2 PTEN MAPRE2 CCND1 DCHS1 PRSS2 VAC14 LAMB2 MPI MRAS ACADM FAS CFH LBR DBT IL6 ASS1 ENG FECH PRSS1 GTF2IRD1 SLC40A1 KLHL40 A2ML1
Protein Mutations 0
SNP 0