Early Prevention Strategies of Severe Proliferative Vitreoretinopathy Base on Precision Diagnosis of Single Cell Sequencingvitreoretinopathy

Early Prevention Strategies of Severe Proliferative Vitreoretinopathy Base on Precision Diagnosis of Single Cell Sequencing

Study of initiating proliferative vitreoretinopathy (PVR)cell subtype (PVR initiating cells (PVR-IC) in RPE cells of rhegmatogenous retinal detachment (RRD) patients; to prove the percentage of PVR-IC decides the risk of serious PVR occurring after surgery; to investigate the safety and efficacy of early local steroids drug intervention in patients with severe postoperative PVR.

Study Overview

• Status: Unknown
• Conditions: Rhegmatogenous Retinal Detachment
• Intervention / Treatment: Procedure: Conventional Surgery for Retinal Detachment; Diagnostic test: RPE cell collection and single cell heterogeneity study; Procedure: Postoperative intervention

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• (1) Age: 18-60 years old, regardless of gender; (2) Clinical diagnosis of with rhegmatogenic retinal detachment (RRD); (3) Surgery for Retinal Detachment is required; (4) Myopia < = 800 degrees; (4) PVR classification: no restrictions; (5) Patients undergoing the first or second operation. (6) Patients volunteered to participate in this study and signed informed consent.

Exclusion Criteria:

• (1) Exudative detachment of retina; (2) Those who are allergic to the drugs used in the study; (3) Combined with other eye diseases: other fundus diseases, glaucoma, corneal opacity diseases, genetic diseases); (4) history of internal eye surgery >=3 times; (5) Postoperative follow-up could not be scheduled; (6) Patients with systemic diseases (such as asthma, heart failure, myocardial infarction, liver failure, kidney failure and other major diseases).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: RD control group; Conventional Surgery for Retinal Detachment	Procedure: Conventional Surgery for Retinal Detachment; Conventional Surgery for Retinal Detachment
Experimental: RD treatment group1; Conventional Surgery for Retinal Detachment，RPE cell collection, single cell heterogeneity study	Procedure: Conventional Surgery for Retinal Detachment; Conventional Surgery for Retinal Detachment; Diagnostic test: RPE cell collection and single cell heterogeneity study; Study of initiating proliferative vitreoretinopathy (PVR)cell subtype (PVR initiating cells (PVR-IC) in RPE cells of rhegmatogenous retinal detachment (RRD) patients, the percentage of which decides the risk of serious PVR occurring after surgery.
Active Comparator: RD treatment group2; Conventional Surgery for Retinal Detachment，RPE cell collection, single cell heterogeneity study, postoperative intervention	Procedure: Conventional Surgery for Retinal Detachment; Conventional Surgery for Retinal Detachment; Diagnostic test: RPE cell collection and single cell heterogeneity study; Study of initiating proliferative vitreoretinopathy (PVR)cell subtype (PVR initiating cells (PVR-IC) in RPE cells of rhegmatogenous retinal detachment (RRD) patients, the percentage of which decides the risk of serious PVR occurring after surgery.; Procedure: Postoperative intervention; Early local steroids drug intervention in patients with severe postoperative PVR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retina reattachment rate	Percentage of participants whose fundus achieved the following conditions simultaneously (B-mode ultrasound showed retinal detachment band height was 0mm, OCT showed subretinal fluid height was 0um)	3 months post operation
Number of Severe PVR	Number of participants whose fundus achieved the following conditions simultaneously (B-mode ultrasound showed proliferative band height exceeded 0mm, OCT showed proliferative band exceeded 0um)	3 months post operation
Best Corrected visual Acuity (BCVA）	Patients' best corrected visual acuity assessed by logarithmic visual acuity(0.5-1.0； For example, normal vision was 1.0)	3 months post operation
Intraocular pressure (IOP)	Patients' IOP(mmHg) assessed by noncontact tonometer	3 months post operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retina reattachment rate	Percentage of participants whose fundus achieved the following conditions simultaneously (B-mode ultrasound showed retinal detachment band height was 0mm, OCT showed subretinal fluid height was 0um)	12 months post operation
Number of Severe PVR	Number of participants whose fundus achieved the following conditions simultaneously (B-mode ultrasound showed proliferative band height exceeded 0mm, OCT showed proliferative band exceeded 0um)	12 months post operation
Best Corrected visual Acuity (BCVA）	Patients' best corrected visual acuity assessed by logarithmic visual acuity(0.5-1.0； For example, normal vision was 1.0)	12 months post operation
Intraocular pressure (IOP)	Patients' IOP(mmHg) assessed by noncontact tonometer	12 months post operation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
RD treatment group1and RD treatment group2	Proportion (%)of PVR-IC subtypes in RPE cells assessed by 10×Genomics single cell sequencing	1 weeks post operation,3 months post operation,12 months post operation
RD treatment group2	Patients' IOP (mmHg)assessed by noncontact tonometer; len's opacity(Grade1-4) assessed by PENTACAM; number of participants who occurred subconjunctival chemosis and hemorrhage(area 1/4-1)	2 weeks post operation,3 months post operation,12 months post operation

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital

Publications and helpful links

General Publications

• Moncada R, Barkley D, Wagner F, Chiodin M, Devlin JC, Baron M, Hajdu CH, Simeone DM, Yanai I. Integrating microarray-based spatial transcriptomics and single-cell RNA-seq reveals tissue architecture in pancreatic ductal adenocarcinomas. Nat Biotechnol. 2020 Mar;38(3):333-342. doi: 10.1038/s41587-019-0392-8. Epub 2020 Jan 13. Erratum In: Nat Biotechnol. 2020 Dec;38(12):1476.
• Voigt AP, Mulfaul K, Mullin NK, Flamme-Wiese MJ, Giacalone JC, Stone EM, Tucker BA, Scheetz TE, Mullins RF. Single-cell transcriptomics of the human retinal pigment epithelium and choroid in health and macular degeneration. Proc Natl Acad Sci U S A. 2019 Nov 26;116(48):24100-24107. doi: 10.1073/pnas.1914143116. Epub 2019 Nov 11.
• Hu Y, Wang X, Hu B, Mao Y, Chen Y, Yan L, Yong J, Dong J, Wei Y, Wang W, Wen L, Qiao J, Tang F. Dissecting the transcriptome landscape of the human fetal neural retina and retinal pigment epithelium by single-cell RNA-seq analysis. PLoS Biol. 2019 Jul 3;17(7):e3000365. doi: 10.1371/journal.pbio.3000365. eCollection 2019 Jul.
• Zhou Y, Liu Z, Welch JD, Gao X, Wang L, Garbutt T, Keepers B, Ma H, Prins JF, Shen W, Liu J, Qian L. Single-Cell Transcriptomic Analyses of Cell Fate Transitions during Human Cardiac Reprogramming. Cell Stem Cell. 2019 Jul 3;25(1):149-164.e9. doi: 10.1016/j.stem.2019.05.020. Epub 2019 Jun 20.
• Peng YR, Shekhar K, Yan W, Herrmann D, Sappington A, Bryman GS, van Zyl T, Do MTH, Regev A, Sanes JR. Molecular Classification and Comparative Taxonomics of Foveal and Peripheral Cells in Primate Retina. Cell. 2019 Feb 21;176(5):1222-1237.e22. doi: 10.1016/j.cell.2019.01.004. Epub 2019 Jan 31.
• Filbin MG, Tirosh I, Hovestadt V, Shaw ML, Escalante LE, Mathewson ND, Neftel C, Frank N, Pelton K, Hebert CM, Haberler C, Yizhak K, Gojo J, Egervari K, Mount C, van Galen P, Bonal DM, Nguyen QD, Beck A, Sinai C, Czech T, Dorfer C, Goumnerova L, Lavarino C, Carcaboso AM, Mora J, Mylvaganam R, Luo CC, Peyrl A, Popovic M, Azizi A, Batchelor TT, Frosch MP, Martinez-Lage M, Kieran MW, Bandopadhayay P, Beroukhim R, Fritsch G, Getz G, Rozenblatt-Rosen O, Wucherpfennig KW, Louis DN, Monje M, Slavc I, Ligon KL, Golub TR, Regev A, Bernstein BE, Suva ML. Developmental and oncogenic programs in H3K27M gliomas dissected by single-cell RNA-seq. Science. 2018 Apr 20;360(6386):331-335. doi: 10.1126/science.aao4750.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (Actual): August 20, 2020

Study Record Updates

• Last Update Posted (Actual): August 20, 2020
• Last Update Submitted That Met QC Criteria: August 19, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Detachment; Vitreoretinopathy, Proliferative
• Other Study ID Numbers: 09.01.10002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: To complete the preliminary report of clinical research.evaluation of the clinical protocol.
• IPD Sharing Time Frame: 2022.12- completing follow-up. Summarizing and analyzing all test data.Comparison of efficacy and summary of adverse reactions.Statistical analysis.Overall outcome evaluation of the clinical protocol.
• IPD Sharing Access Criteria: All access
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No