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Not yet recruitingNCT06497608Updated Jul 12, 2024

Single-Cell Insights Into Diabetic Retinopathy Mechanisms

An observational study in Diabetic Retinopathy, sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-12.

Sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 1 month ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
66
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Diabetic Retinopathy
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In context

Retinal Diseases

815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.

This study's planned enrollment of 66 is below the median of 180 across 282 observational studies indexed under Retinal Diseases.

Browse Retinal Diseases studies →

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 173 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients who visit the Department of Ophthalmology at Shanghai General Hospital and meet the inclusion and exclusion criteria of this study.

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

Exclusion Criteria:

  • Patients with severe systemic diseases such as autoimmune diseases or cancer
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Study design

Observational model
Case-control
Time perspective
Other
Enrollment
66 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • scRNA_DR

    Patients with proliferative diabetic retinopathy who underwent prosthetic eye implantation.

  • scRNA_normal

    Body donors without history of diabetic retinopathy

  • Validate_DR

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

  • Validate_normal

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

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What researchers measure

Primary outcomes

  1. Single cell sequencing result

    Single cell RNA and ATAC sequencing of human retinas

    Time frame: 1 month

Secondary outcomes

  1. Validation experiment result

    Experiments such as ELISA and immunofluorescence staining to validate the result from single cell sequencing

    Time frame: 1 month

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 35061025 ↗
  • 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. PubMed 33674409 ↗
  • 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. PubMed 32734440 ↗
  • 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. PubMed 28212749 ↗
  • 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. PubMed 20580421 ↗

Individual participant data

Plan to share: Undecided — Due to the confidentiality policy of the Chinese National Health Council and institutional patient privacy regulations, we have not decided on the plan to share IPD. However, the data are available from the corresponding authors upon request.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06497608
Lead sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Responsible party
Zhi Zheng (Prof., Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Jul 12, 2024
Start date
Jul 2024 (estimated)
Primary completion
Sep 2024 (estimated)
Completion
Jul 2027 (estimated)
Last update
Jul 12, 2024

Study contacts

Yujie Wang, Dr.
Contact
yujiwang11@student.unimelb.edu.au
0061-422510790
Zhi Zheng, Prof.
principal investigator · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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