NCT07434362

Brief Summary

This prospective cross-sectional study aims to evaluate the association between serum endocan, alarin, and galanin-like peptide levels and the stages of diabetic retinopathy (DR), as well as their relationship with optical coherence tomography (OCT) findings. A total of 120 participants will be included: 30 patients without diabetic retinopathy, 30 with non-proliferative diabetic retinopathy, 30 with proliferative diabetic retinopathy, and 30 healthy control subjects. In addition to routine preoperative blood sampling, an additional 5 mL of venous blood will be collected for biomarker analysis using ELISA. Macular and peripapillary retinal nerve fiber layer measurements will be obtained using OCT. Serum biomarker levels will be compared across DR stages and analyzed for correlation with OCT parameters.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2026

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

2 days

First QC Date

February 20, 2026

Last Update Submit

February 20, 2026

Conditions

Keywords

Diabetic RetinopathyEndocanAlarinGalanin-Like PeptideOptical Coherence TomographyRetinal Nerve Fiber Layer

Outcome Measures

Primary Outcomes (3)

  • Serum Endocan Level

    Serum endocan concentration measured using ELISA and compared across diabetic retinopathy stages.

    At baseline (preoperative blood sampling)

  • Serum Alarin Level

    Serum alarin concentration measured by ELISA and analyzed according to diabetic retinopathy severity.

    At baseline

  • Serum Galanin-Like Peptide Level

    Serum galanin-like peptide concentration measured using ELISA and compared between study groups.

    At baseline

Study Arms (4)

Diabetes Mellitus Without Retinopathy

OTHER

Patients diagnosed with diabetes mellitus without clinical evidence of diabetic retinopathy. Participants will undergo OCT examination and additional venous blood sampling for biomarker analysis.

Procedure: Venous Blood SamplingProcedure: Optical Coherence Tomography (OCT)

Non-Proliferative Diabetic Retinopathy (NPDR)

OTHER

Patients with clinically diagnosed non-proliferative diabetic retinopathy who will undergo OCT examination and additional venous blood sampling for serum biomarker measurement.

Procedure: Venous Blood SamplingProcedure: Optical Coherence Tomography (OCT)

Proliferative Diabetic Retinopathy (PDR)

OTHER

Patients with clinically diagnosed proliferative diabetic retinopathy who will undergo OCT examination and additional venous blood sampling for serum biomarker analysis.

Procedure: Venous Blood SamplingProcedure: Optical Coherence Tomography (OCT)

Healthy Control Group

OTHER

Age-matched control participants without diabetes or retinal pathology who will undergo OCT examination and venous blood sampling for comparative biomarker evaluation.

Procedure: Venous Blood SamplingProcedure: Optical Coherence Tomography (OCT)

Interventions

Collection of 5 mL of venous blood in addition to routine preoperative sampling for the measurement of serum endocan, alarin, and galanin-like peptide levels using ELISA.

Diabetes Mellitus Without RetinopathyHealthy Control GroupNon-Proliferative Diabetic Retinopathy (NPDR)Proliferative Diabetic Retinopathy (PDR)

Non-invasive optical coherence tomography imaging of the macula and peripapillary retinal nerve fiber layer using a Canon OCT device for structural retinal assessment.

Diabetes Mellitus Without RetinopathyHealthy Control GroupNon-Proliferative Diabetic Retinopathy (NPDR)Proliferative Diabetic Retinopathy (PDR)

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 40 to 70 years.
  • Diagnosis of diabetes mellitus (for diabetic groups).
  • For control group: absence of diabetes mellitus and no retinal or optic nerve pathology.

You may not qualify if:

  • Presence of systemic or ocular inflammatory disease.
  • Any ocular disease other than diabetic retinopathy that may affect the retina or optic nerve.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fethi Sekin City Hospital

Elâzığ, Elaziğ, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetic RetinopathyDiabetes Mellitus

Interventions

Blood Specimen CollectionTomography, Optical Coherence

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesTomography, OpticalOptical ImagingDiagnostic ImagingTomography

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 20, 2026

First Posted

February 25, 2026

Study Start

January 30, 2026

Primary Completion

February 1, 2026

Study Completion

February 18, 2026

Last Updated

February 25, 2026

Record last verified: 2026-02

Locations