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

Rhegmatogenous Retinal Detachment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04520789
• Other study ID #: 09.01.10002
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2020
• Source: Shanghai 10th People's Hospital
• Contact: Fang Wang, MD,phD
• Phone: +86-18917683335
• Email: 18917683335[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Retinal Detachment
• Rhegmatogenous Retinal Detachment

Intervention

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
• Conventional Surgery for Retinal Detachment
Conventional Surgery for Retinal Detachment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

References & Publications (6)

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, Suvà 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	Intraocular pressure (IOP)	Patients' IOP(mmHg) assessed by noncontact tonometer	3 months post operation
Secondary	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
Secondary	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
Secondary	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
Secondary	Intraocular pressure (IOP)	Patients' IOP(mmHg) assessed by noncontact tonometer	12 months post operation