SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03622593

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

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)

This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).

NCT03622593 Diabetic Macular Edema
MeSH: Edema Macular Edema
HPO: Anasarca Cystoid macular edema Edema Macular edema

3 Interventions

Name: Aflibercept

Description: Aflibercept will be administered by intravitreal (IVT) injection into the study eye once every 8 weeks (Q8W).

Type: Drug

C: Aflibercept Q8W

Name: Faricimab

Description: Faricimab will be administered by IVT injection into the study eye either once every 8 weeks (Q8W) in arm A or as specified in the protocol in arm B.

Type: Drug

A: Faricimab Q8W B: Faricimab As Specified in Protocol

Name: Sham Procedure

Description: The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in all three treatments arms at applicable visits to maintain masking among treatment arms.

Type: Drug

A: Faricimab Q8W B: Faricimab As Specified in Protocol C: Aflibercept Q8W


Primary Outcomes

Description: As measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.

Measure: Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) at 1 Year

Time: Baseline (Day 1) and 1 year

Secondary Outcomes

Measure: Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity (DRS) Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) at 1 Year

Time: Baseline and 1 year

Measure: Change From Baseline in BCVA Over Time

Time: From Baseline up to 2 years

Measure: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline Over Time

Time: From Baseline up to 2 years

Measure: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline Over Time

Time: From Baseline up to 2 years

Measure: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline Over Time

Time: From Baseline up to 2 years

Measure: Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline Over Time

Time: From Baseline up to 2 years

Measure: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline Over Time

Time: From Baseline up to 2 years

Measure: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline Over Time

Time: From Baseline up to 2 years

Measure: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline Over Time

Time: From Baseline up to 2 years

Measure: Percentage of Participants Avoiding a Loss of ≥0 Letters in BCVA From Baseline Over Time

Time: From Baseline up to 2 years

Measure: Percentage of Participants With a ≥2-Step DRS Improvement From Baseline on the ETDRS DRSS Over Time

Time: From Baseline up to 2 years

Measure: Percentage of Participants With a ≥3-Step DRS Improvement From Baseline on the ETDRS DRSS Over Time

Time: From Baseline up to 2 years

Measure: Percentage of Participants Gaining ≥15 Letters or Achieving BCVA of ≥84 Letters Over Time

Time: Up to 2 years

Measure: Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time

Time: Up to 2 years

Measure: Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time

Time: Up to 2 years

Measure: Percentage of Participants Who Develop New Proliferative Diabetic Retinopathy Over Time

Time: Up to 2 years

Measure: Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 1 Year

Time: 1 year

Measure: Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 2 Years

Time: 2 years

Measure: Change From Baseline in Central Subfield Thickness (CST) Over Time

Time: From Baseline up to 2 years

Measure: Percentage of Participants with Absence of DME Over Time

Time: Up to 2 years

Measure: Percentage of Participants with Absence of Intraretinal Fluid Over Time

Time: Up to 2 years

Measure: Percentage of Participants with Absence of Subretinal Fluid Over Time

Time: Up to 2 years

Measure: Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid Over Time

Time: Up to 2 years

Measure: Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time

Time: From Baseline up to 2 years

Measure: Percentage of Participants With Ocular Adverse Events

Time: Up to 2 years

Measure: Percentage of Participants With Non-Ocular Adverse Events

Time: Up to 2 years

Measure: Plasma Concentration of Faricimab Over Time

Time: Pre-dose on Day 1; Weeks 4, 28, 52, 76, and 100; and at Early Termination Visit (up to 2 years)

Measure: Percentage of Participants With Presence of Anti-Drug Antibodies

Time: Pre-dose on Day 1; Weeks 4, 28, 52, 76, and 100; and at Early Termination Visit (up to 2 years)

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 Q12W

Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 1 Year. --- Q12W ---

Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 2 Years. --- Q12W ---


2 Q16W

Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 1 Year. --- Q12W --- --- Q16W ---

Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 2 Years. --- Q12W --- --- Q16W ---



HPO Nodes


HPO:
Anasarca
Genes 3
UBR1 PLVAP PMM2
Cystoid macular edema
Genes 14
MFRP HLA-A RLBP1 PRPF8 RDH5 POMGNT1 REEP6 PRPH2 DHDDS ARHGEF18 ARL3 RHO PDE6G NOD2
Edema
Genes 364
EPHB4 IL10 MKKS CFH PIGN HFE MYD88 UBR1 IL12A PRPF31 HGD PRSS1 TREX1 IBA57 ERBB3 RELN TMPRSS15 SLC29A3 LZTR1 ERCC5 PRTN3 PLVAP DIS3L2 ATP7B PDE6G HLA-A ACADM HLA-B SPINK1 KIF1A MYO1E ACAT1 ERAP1 INHBA LEMD3 HLA-DPA1 HLA-DPB1 IFT172 SMC1A HLA-DRB1 PIEZO1 INPPL1 SPTA1 SPTB B2M ACTA1 KIAA0586 ACTB NAGA PSMB4 HDAC8 GATA1 COQ8B GATA2 PSMB9 CD55 GBA ACTG1 GBE1 SOX18 DHDDS PTPN22 TSC1 ACTN4 BCKDHA TSC2 BCKDHB CCND1 HMGCL CD46 BCL2 KLHL41 KCTD1 PSPH BCL6 DBT RRAS GPR101 NEB PTEN MFRP COQ2 ADA TRIP13 TRIP11 LYST NEK9 KLRC4 ZNHIT3 CHRNA1 F12 PTH1R MRPS22 MEFV PHGDH NLRC4 NDUFS4 RYR1 STAT4 CHRND CHRNG HELLPAR NOD2 SLC35D1 BSND TMEM260 CCN6 CDAN1 PTPN2 NEK1 BMPR1A NPHS2 PTPN11 NEU1 PTPN14 ANTXR2 OTULIN PLAA GLA PIGA BRAF CLCNKA CLCNKB FIG4 PTPRO REEP6 PIK3CA POMP GLE1 SGPL1 HPGD DHCR7 RIN2 SUMF1 SCN4A MIF A2ML1 BUB1 FECH BUB1B AHCY PKLR ALPK3 WDR35 FGA KIAA1109 FGB PEX2 SERPING1 PEX5 ANTXR1 KCNQ2 KMT2A ALG8 CCR1 AKT1 C4A RBM8A FGFR3 IFT80 GNAQ BMPER PLD1 FGG CAMTA1 PRKAG2 UROS MAPRE2 KIT TALDO1 LTBP4 NIPBL DNASE1L3 NAXE FOXG1 NR1H4 IL23R ALG1 KIF11 IGSF3 DNMT1 COL1A1 SPINK5 PMM2 RAD21 COL1A2 FOXC2 MPI COL2A1 VEGFC NPHS1 KRAS RAF1 RAG1 KRT2 RAG2 FLNB TCF4 RANBP2 COL8A2 FAT4 NR2E3 PDSS2 FLT4 KRT13 COL11A1 ZEB1 NRAS ATN1 FN1 TAPT1 RASA2 WDR34 NUP107 SLC25A4 ADAMTS3 ADAMTS2 NRL RB1 CLIP2 DSP DYNC2H1 GPR35 SLC26A2 ACAD9 KLHL40 SMCHD1 RRM2B POLG WNT7A GNPTAB TPRKB TUBB LAMA2 IKBKG AGGF1 BAZ1B RDH5 WDR60 POMGNT1 LAMB2 PRPH2 ARHGEF18 CASP10 ABCC9 TWNK MRPS16 GJC2 APOA1 SAMHD1 CHD7 DUX4 OCRL AIP CPN1 LBR APOE OSGEP CPS1 RFC2 GTF2IRD1 GPC6 PRPF8 CFI TEK FAS CBL FASLG CTSA ANKRD55 ANKH SLC40A1 SHANK3 ABCC6 NLRP3 RHO KIF7 RIT1 RLBP1 GRIP1 MST1 SLC17A5 RMRP FRMD4A LMOD3 ARHGDIA USP8 RASGRP1 LIG4 LIMK1 OTC VAC14 ARL3 CD247 CCDC88A GTF2I EGFR IGH KLF1 DCLRE1C SMC3 LACC1 SETD5 LMX1B ASAH1 IL12A-AS1 CD28 GUSB CCBE1 PRF1 SLCO2A1 ASL FRG1 GYPC BTNL2 SLC25A13 ALG9 SCARB2 EBP NAXD TLR4 FSHR ASS1 LPIN2 CHEK2 PRKAR1A PRKCD UBAC2 SMS PAX2 RP9 CTLA4 ELN HADHA HADHB TNFRSF1A TNFRSF1B HBA1 BUB3 HBA2 POLG2 KAT6B MAP2K1 IL1RN LYZ MAP2K2 CDC42 CEP57 ENG IL2RA IL2RB IL2RG TBL2 CDH11 IL6 EPB41 TP53 MVK IL7R SMAD4 CDK5 PLCE1 SOS1 SOS2
Macular edema
Genes 19
MFRP HLA-A RLBP1 PRPF8 NRL RDH5 POMGNT1 PRPF31 REEP6 PRPH2 DHDDS ARHGEF18 TREX1 NR2E3 ARL3 RP9 RHO PDE6G NOD2