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Role of the Serum Exosomal miRNA in Diabetic Retinopathy (DR)

Prognostic Role of Serum Exosomal miRNA and Its Function in Pathogenesis of Diabetic Retinopathy (DR)

Diabetic retinopathy (DR) is one of the most common causes of blindness worldwide. It is a progressive disease and its detection in early phases is very crucial for visional outcomes. miRNA of exosomes has been recently considered as a potential circulating marker of oculopathy, including age-related macular degeneration and uveal melanoma. Therefore, the primary objective of this study is to evaluate whether the serum exosomal miRNA could be prospective prognosis biomarker to investigate the initiation and development of DR. This case-control study is planned to include diabetic patients, and patients without DR, which serve as controls. Other participants will be divided into four groups by different DR stages according to the guideline from AAO. Information and samples of all trial participants will be collected at the inception of the study, including basic information, medical history, serum samples, and several ophthalmologic examinations. Then these information and examinations will be collected at regular intervals: every 12 months until 5 years. Different statistical methods will be used to identify significant associations between DR progression and different exosomal miRNA. We hypothesis that there could exist alert level of exosomal miRNAs which indicate the onset and development of DR in diabetic patients. Moreover, the selected exosomal miRNAs, being considered together with other information including medical history, blood indicators and ophthalmologic examinations, to be chosen-optimized as a prognostic model for DR, which may help predicting high risk groups of DR and those with poor prognosis. Based on clinical trial data, we will further discuss about possible roles of identified miRNA of exosomes in the pathogenesis of DR.

Visão geral do estudo

Status

Ainda não está recrutando

Tipo de estudo

Observacional

Inscrição (Antecipado)

200

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

19 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Patients will be chosen according to the inclusion and exclusion standard and written informed consent will be obtained from all participants.

Exit criteria: During the research, for his / her own consideration or at the request of the investigator the patient may withdraw from the trial at any time. For each subject who withdrew from the trial, the investigator must detail the subject's exit date, the reason, and other information in case report form(CRF).

Descrição

Inclusion Criteria:

  • Type II diabetics,
  • Age > 18 years old,
  • Have not accepted anti-VEGF therapy,
  • Without turbid ocular media or corestenoma that interfere with ophthalmic fundus examination (patients with PDR are excluded).

Exclusion Criteria:

-Patients with any following eye disease in studied eye:

  1. active infections (i.e., blepharitis, keratitis, scleritis, conjunctivitis, etc.),
  2. fundus oculi diseases other than DR (i.e., retinal vein occlusion, choroidal neovascularization, retinal detachment, macular hole, vitreous traction in macular region, epiretinal membrane, etc.) ,
  3. uncontrollable glaucoma (intraocular pressure is no less than 25mmHg after anti-glaucoma agents) or after filtering surgery for glaucoma;

    -Patients who have accepted any following treatment in studied eyes:

  4. intraocular injection of corticosteroids (i.e., Triamcinolone) within 3 months, or peribulbar injection of corticosteroids within 1 months,
  5. vitrectomy surgery,
  6. anti-VEGF therapy for eyes or other parts of the body (i.e., ranibizumab, bevacizumab, conbercept, aflibercept, pegaptanib sodium, etc),
  7. any intraocular surgery within 3 months (i.e., cataract surgery, YAG laser capsulectomy, etc),
  8. ocular surgery related with macular region;

    -Patients with any following systemic diseases:

  9. failed blood sugar control within 3 months (Changing treatment from oral antidiabetic therapy into insulin treatment, or start using insulin pump, or doubling the number of injections),
  10. damaged renal function (Crea is found to be 2 times higher than the upper limit in central laboratory) or abnormal liver function (ALT, AST are found to be 2 times higher than the upper limit in center of the laboratory),
  11. failed blood pressure control within 3 months (systolic blood pressure is no less than 140 mmHg or diastolic blood pressure is no less than 90 mmHg after hypotensor treatment),
  12. systemic infection that requires oral, intramuscular or intravenous administration,
  13. stroke, transient ischemic attack, myocardial infarction or acute congestive heart failure within 6months,
  14. coagulation dysfunction (thrombin time ≥ normal upper limit of 3 seconds, activation of partial thromboplastin time ≥ normal upper limit of 10 seconds),
  15. using drugs that may be toxic to the lens, retina or optic nerve during this research (i.e., deferoxamine, chloroquine, hydrogenated chloroquine (chloroquinol), tamoxifen, phenothiazine, or ethambutol, etc.),
  16. diagnosed systemic immune diseases (i.e., mandatory spondylitis, systemic lupus erythematosus, etc.) or any uncontrollable clinical diseases (such as AIDS, malignancy, active hepatitis, severe mental, neurological, cardiovascular, respiratory and other systems diseases, etc.);

    -Others:

  17. pregnant and lactating women,
  18. those who participated in any drug clinical trials (not including vitamins and minerals) within 3 months,
  19. those researchers believe that need to be excluded.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Group 1
Patients without DR. Information and samples of all trial participants at enrollment will be collected at the inception of the study, including: basic information, basic medical records, hematological examination, ophthalmic examination. These information and examinations will be collected at regular intervals: every 12 months until 5 years.
Hematological examination includes biochemical examination, routine coagulation test, HbA1c, C reactive protein (CRP);Ophthalmic examination includes the basic situation and clinical diagnosis of eyes, ETDRS visual acuity chart score, intraocular pressure, OCT examination, OCTA examination, fundus photos, Optos wide angle fundus imaging.
Group 2

Patients with mild non-proliferative DR (NPDR). Diagnosed according to Diabetic retinopathy PPP - Updated 2016.

Information and samples of all trial participants at enrollment will be collected at the inception of the study, including: basic information, basic medical records, hematological examination, ophthalmic examination. These information and examinations will be collected at regular intervals: every 12 months until 5 years.

Hematological examination includes biochemical examination, routine coagulation test, HbA1c, C reactive protein (CRP);Ophthalmic examination includes the basic situation and clinical diagnosis of eyes, ETDRS visual acuity chart score, intraocular pressure, OCT examination, OCTA examination, fundus photos, Optos wide angle fundus imaging.
Group 3

Patients with moderate NPDR. Diagnosed according to Diabetic retinopathy PPP - Updated 2016.

Information and samples of all trial participants at enrollment will be collected at the inception of the study, including: basic information, basic medical records, hematological examination, ophthalmic examination.These information and examinations will be collected at regular intervals: every 12 months until 5 years.

Hematological examination includes biochemical examination, routine coagulation test, HbA1c, C reactive protein (CRP);Ophthalmic examination includes the basic situation and clinical diagnosis of eyes, ETDRS visual acuity chart score, intraocular pressure, OCT examination, OCTA examination, fundus photos, Optos wide angle fundus imaging.
Group 4

Patients with moderate NPDR. Diagnosed according to Diabetic retinopathy PPP - Updated 2016.

Information and samples of all trial participants at enrollment will be collected at the inception of the study, including: basic information, basic medical records, hematological examination, ophthalmic examination. These information and examinations will be collected at regular intervals: every 12 months until 5 years.

Hematological examination includes biochemical examination, routine coagulation test, HbA1c, C reactive protein (CRP);Ophthalmic examination includes the basic situation and clinical diagnosis of eyes, ETDRS visual acuity chart score, intraocular pressure, OCT examination, OCTA examination, fundus photos, Optos wide angle fundus imaging.
Group 5

Proliferative DR (PDR). Diagnosed according to Diabetic retinopathy PPP - Updated 2016.

Information and samples of all trial participants at enrollment will be collected at the inception of the study, including: basic information, basic medical records, hematological examination, ophthalmic examination.These information and examinations will be collected at regular intervals: every 12 months until 5 years.

Hematological examination includes biochemical examination, routine coagulation test, HbA1c, C reactive protein (CRP);Ophthalmic examination includes the basic situation and clinical diagnosis of eyes, ETDRS visual acuity chart score, intraocular pressure, OCT examination, OCTA examination, fundus photos, Optos wide angle fundus imaging.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
exosomal miRNAs in serum samples
Prazo: samples will be collected every 12 months later until 5 years
In discovery set, miRNA sequencing of serum exosomes will be performed for each sample. Data will be analyzed using statistical methods. Potential miRNAs that show group-differentiation will be selected in combination with information and test results.Based on these selected miRNAs, the same assays will be repeated on all validation set samples to screen out significant miRNA.
samples will be collected every 12 months later until 5 years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Antecipado)

1 de julho de 2018

Conclusão Primária (Antecipado)

1 de julho de 2023

Conclusão do estudo (Antecipado)

1 de julho de 2023

Datas de inscrição no estudo

Enviado pela primeira vez

25 de agosto de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

25 de agosto de 2017

Primeira postagem (Real)

29 de agosto de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

29 de agosto de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

25 de agosto de 2017

Última verificação

1 de agosto de 2017

Mais Informações

Termos relacionados a este estudo

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em hematological examination, ophthalmic examination

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