NCT03927118

Brief Summary

This study evaluates the effect of dexamethasone implant which is an intraocular corticosteroid on the optic nerve fibers. Retinal nerve fiber thicknesses and optic nerve head pitting rates were measured before and 6 months after the injection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2019

Completed
Last Updated

May 13, 2019

Status Verified

May 1, 2019

Enrollment Period

7 months

First QC Date

April 23, 2019

Last Update Submit

May 9, 2019

Conditions

Glaucoma and Ocular HypertensionDiabetic Macular EdemaIntravenous Drug UsageOptic Disk Disorders

Keywords

Diabetic maculopathydexamethasone implantoptic discvascular endothelial growth factor

Outcome Measures

Primary Outcomes (1)

  • Peripapillary RNFL thickness measurements

    micrometer

    six month

Interventions

intravitreal dexamethasone implant applicationPROCEDURE

Peripapillary RNFL thickness measurements and colored fundus photographs were compared before and 6 months after intravitreal DEX implant injection. The cup-to-disc ratios of fundus photographs were calculated using the Image-J program.

Also known as: The Effect of Dexamethasone Implant on Retinal Nerve Fiber and Optic Disc in Diabetic maculopathy.

Eligibility Criteria

Age20 Years - 80 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsIndividuals over 20 years of age were included in the study.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diabetic patient group will be included in the study.

You may qualify if:

  • Patients who underwent first time intravitreal injection

You may not qualify if:

  • Previously received any surgery
  • Proliferative diabetic retinopathy
  • Glaucoma or glaucoma suspicion
  • Optic disc fatigue
  • Optic disc edema
  • Uveitis and media opacity
  • Blurred of image clarity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bülent Ecevit Üniversitesi.

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

Related Publications (12)

  • Du JH, Li X, Li R, Xu L, Ma RR, Liu SF, Zhang Z, Sun HZ. Elevation of serum apelin-13 associated with proliferative diabetic retinopathy in type 2 diabetic patients. Int J Ophthalmol. 2014 Dec 18;7(6):968-73. doi: 10.3980/j.issn.2222-3959.2014.06.10. eCollection 2014.

    PMID: 25540748BACKGROUND

  • Liu L, Wu X, Liu L, Geng J, Yuan Z, Shan Z, Chen L. Prevalence of diabetic retinopathy in mainland China: a meta-analysis. PLoS One. 2012;7(9):e45264. doi: 10.1371/journal.pone.0045264. Epub 2012 Sep 20.

    PMID: 23028893BACKGROUND

  • Assmann TS, Brondani LA, Boucas AP, Rheinheimer J, de Souza BM, Canani LH, Bauer AC, Crispim D. Nitric oxide levels in patients with diabetes mellitus: A systematic review and meta-analysis. Nitric Oxide. 2016 Dec 30;61:1-9. doi: 10.1016/j.niox.2016.09.009. Epub 2016 Sep 24.

    PMID: 27677584BACKGROUND

  • Suwanpradid J, Rojas M, Behzadian MA, Caldwell RW, Caldwell RB. Arginase 2 deficiency prevents oxidative stress and limits hyperoxia-induced retinal vascular degeneration. PLoS One. 2014 Nov 6;9(11):e110604. doi: 10.1371/journal.pone.0110604. eCollection 2014.

    PMID: 25375125BACKGROUND

  • Celik M, Cerrah S, Arabul M, Akalin A. Relation of asymmetric dimethylarginine levels to macrovascular disease and inflammation markers in type 2 diabetic patients. J Diabetes Res. 2014;2014:139215. doi: 10.1155/2014/139215. Epub 2014 Apr 3.

    PMID: 24804267BACKGROUND

  • Lluch P, Segarra G, Medina P. Asymmetric dimethylarginine as a mediator of vascular dysfunction in cirrhosis. World J Gastroenterol. 2015 Aug 28;21(32):9466-75. doi: 10.3748/wjg.v21.i32.9466.

    PMID: 26327755BACKGROUND

  • Heunisch F, Chaykovska L, von Einem G, Alter M, Dschietzig T, Kretschmer A, Kellner KH, Hocher B. ADMA predicts major adverse renal events in patients with mild renal impairment and/or diabetes mellitus undergoing coronary angiography. Medicine (Baltimore). 2017 Feb;96(6):e6065. doi: 10.1097/MD.0000000000006065.

    PMID: 28178159BACKGROUND

  • Franceschelli S, Ferrone A, Pesce M, Riccioni G, Speranza L. Biological functional relevance of asymmetric dimethylarginine (ADMA) in cardiovascular disease. Int J Mol Sci. 2013 Dec 16;14(12):24412-21. doi: 10.3390/ijms141224412.

    PMID: 24351825BACKGROUND

  • Yin YL, Zhu ML, Wan J, Zhang C, Pan GP, Lu JX, Ping S, Chen Y, Zhao FR, Yu HY, Guo T, Jian X, Liu LY, Zhang JN, Wan GR, Wang SX, Li P. Traditional Chinese medicine xin-mai-jia recouples endothelial nitric oxide synthase to prevent atherosclerosis in vivo. Sci Rep. 2017 Mar 2;7:43508. doi: 10.1038/srep43508.

    PMID: 28252100BACKGROUND

  • Marcovecchio ML, Widmer B, Turner C, Dunger DB, Dalton RN. Asymmetric dimethylarginine in young people with Type 1 diabetes: a paradoxical association with HbA(1c). Diabet Med. 2011 Jun;28(6):685-91. doi: 10.1111/j.1464-5491.2011.03252.x.

    PMID: 21294768BACKGROUND

  • Ersoy B, Eroglu N, Cetin M, Onur E, Ozkol M, Coskun S. Asymmetric dimethylarginine levels and diabetes duration: Relationship with measures of subclinical atherosclerosis and cardiac function in children and adolescents with Type 1 diabetes. Diab Vasc Dis Res. 2018 May;15(3):196-203. doi: 10.1177/1479164118757921. Epub 2018 Mar 2.

    PMID: 29498294BACKGROUND

  • Lin KY, Ito A, Asagami T, Tsao PS, Adimoolam S, Kimoto M, Tsuji H, Reaven GM, Cooke JP. Impaired nitric oxide synthase pathway in diabetes mellitus: role of asymmetric dimethylarginine and dimethylarginine dimethylaminohydrolase. Circulation. 2002 Aug 20;106(8):987-92. doi: 10.1161/01.cir.0000027109.14149.67.

    PMID: 12186805BACKGROUND

MeSH Terms

Conditions

GlaucomaOcular HypertensionOptic Nerve Diseases

Condition Hierarchy (Ancestors)

Eye DiseasesCranial Nerve DiseasesNervous System Diseases

Study Officials

  • Atilla Alpay, Ass. Prf.

    Zonguldak Bulent Ecevit University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 23, 2019

First Posted

April 25, 2019

Study Start

February 1, 2018

Primary Completion

September 1, 2018

Study Completion

January 31, 2019

Last Updated

May 13, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)