Single-Cell Insights Into Diabetic Retinopathy Mechanisms

NCT ID: NCT06497608

Last Updated: 2024-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-31

Study Completion Date

2027-07-31

Brief Summary

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This study aims to uncover the cellular and molecular mechanisms of diabetic retinopathy through single-cell sequencing to identify new therapeutic targets.

The study will collect retinal tissue samples from 3 patients with advanced proliferative diabetic retinopathy who underwent prosthetic eye implantation and 3 normal cadaver donors. Additionally, aqueous humor, vitreous fluid, and plasma samples from patients with severe diabetic retinopathy requiring surgery and macular hole surgery patients without diabetic retinopathy will be analyzed using ELISA, qPCR, and Western Blot. These experiments will validate sequencing results and explore the pathogenesis of diabetic retinopathy to identify potential treatment targets.

Detailed Description

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Diabetic retinopathy is the leading cause of blindness among the working population worldwide. However, its pathogenesis is not fully understood, and effective prevention and treatment methods are limited. This study, initiated by Shanghai First People's Hospital, aims to explore the cellular and molecular mechanisms underlying its occurrence through methods such as single-cell sequencing, to identify new intervention targets. This study plans to collect retinal tissue samples from 3 patients each who underwent prosthetic eye implantation due to late-stage proliferative diabetic retinopathy blindness and from 3 normal cadaver donors at the Ophthalmology Department of Shanghai First People's Hospital for single-cell sequencing and bioinformatics analysis. Additionally, samples of aqueous humor, vitreous fluid, and plasma will be collected from 30 patients with severe diabetic retinopathy requiring surgery and from 30 macular hole surgery patients without diabetic retinopathy. These samples will be subjected to experiments such as ELISA, qPCR, and Western Blot to validate sequencing results, investigate the pathogenesis of diabetic retinopathy, and identify potential therapeutic targets.

Conditions

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Diabetic Retinopathy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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scRNA_DR

Patients with proliferative diabetic retinopathy who underwent prosthetic eye implantation.

No interventions assigned to this group

scRNA_normal

Body donors without history of diabetic retinopathy

No interventions assigned to this group

Validate_DR

Patients with proliferative diabetic retinopathy (PDR) who underwent vitrectomy surgery

No interventions assigned to this group

Validate_normal

Patients who underwent vitrectomy surgery for macular hole (MH) and did not have diabetic retinopathy (DR)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* For the single-cell sequencing group: Patients with advanced proliferative diabetic retinopathy (PDR) resulting in blindness or ocular atrophy, who voluntarily opt for enucleation and ocular prosthesis implantation surgery, and have no systemic or local contraindications to surgery. For the validation group: patients with severe PDR lesions requiring vitrectomy, and who also have no systemic or local contraindications to surgery.
* Patients who voluntarily agree to participate in this clinical trial and sign the informed consent form.

Exclusion Criteria

* Patients with severe systemic diseases such as autoimmune diseases or cancer
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Zhi Zheng

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhi Zheng, Prof.

Role: PRINCIPAL_INVESTIGATOR

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Central Contacts

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Yujie Wang, Dr.

Role: CONTACT

0061-422510790

References

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Hu Z, Mao X, Chen M, Wu X, Zhu T, Liu Y, Zhang Z, Fan W, Xie P, Yuan S, Liu Q. Single-Cell Transcriptomics Reveals Novel Role of Microglia in Fibrovascular Membrane of Proliferative Diabetic Retinopathy. Diabetes. 2022 Apr 1;71(4):762-773. doi: 10.2337/db21-0551.

Reference Type BACKGROUND
PMID: 35061025 (View on PubMed)

Niu T, Fang J, Shi X, Zhao M, Xing X, Wang Y, Zhu S, Liu K. Pathogenesis Study Based on High-Throughput Single-Cell Sequencing Analysis Reveals Novel Transcriptional Landscape and Heterogeneity of Retinal Cells in Type 2 Diabetic Mice. Diabetes. 2021 May;70(5):1185-1197. doi: 10.2337/db20-0839. Epub 2021 Mar 5.

Reference Type BACKGROUND
PMID: 33674409 (View on PubMed)

Van Hove I, De Groef L, Boeckx B, Modave E, Hu TT, Beets K, Etienne I, Van Bergen T, Lambrechts D, Moons L, Feyen JHM, Porcu M. Single-cell transcriptome analysis of the Akimba mouse retina reveals cell-type-specific insights into the pathobiology of diabetic retinopathy. Diabetologia. 2020 Oct;63(10):2235-2248. doi: 10.1007/s00125-020-05218-0. Epub 2020 Jul 30.

Reference Type BACKGROUND
PMID: 32734440 (View on PubMed)

Ziegenhain C, Vieth B, Parekh S, Reinius B, Guillaumet-Adkins A, Smets M, Leonhardt H, Heyn H, Hellmann I, Enard W. Comparative Analysis of Single-Cell RNA Sequencing Methods. Mol Cell. 2017 Feb 16;65(4):631-643.e4. doi: 10.1016/j.molcel.2017.01.023.

Reference Type BACKGROUND
PMID: 28212749 (View on PubMed)

Cheung N, Mitchell P, Wong TY. Diabetic retinopathy. Lancet. 2010 Jul 10;376(9735):124-36. doi: 10.1016/S0140-6736(09)62124-3. Epub 2010 Jun 26.

Reference Type BACKGROUND
PMID: 20580421 (View on PubMed)

Other Identifiers

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2023321

Identifier Type: -

Identifier Source: org_study_id

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