Effect of Dexamethasone Implant on Optic Disc

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ClinicalTrials.gov Identifier: NCT03927118

Recruitment Status : Completed

First Posted : April 25, 2019

Last Update Posted : May 13, 2019

Sponsor:

Information provided by (Responsible Party):

Atilla Alpay, Bulent Ecevit University

Study Description

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.

Condition or disease	Intervention/treatment
Glaucoma and Ocular Hypertension Diabetic Macular Edema Intravenous Drug Usage Optic Disk Disorders	Procedure: intravitreal dexamethasone implant application

Detailed Description:

Diabetic macular edema is the most frequent ocular complication of diabetes resulting in irreversible loss of vision if untreated. Dexamethasone implant implant is used to treat macular edema due to diabetes. It stay in the vitreous for 6 months after intravitreal administration.

Dexamethasone implant can lead to retinal nerve fiber layer and optic nerve damage by both increasing intraocular pressure and its direct effect on neural tissue during the effective 6-month period.

Study Design

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Study Type :	Observational
Actual Enrollment :	43 participants
Observational Model:	Case-Control
Time Perspective:	Prospective
Official Title:	The Effect of Dexamethasone Implant on Retinal Nerve Fiber and Optic Disc Morphology in Patients With Diabetic Maculopathy
Actual Study Start Date :	February 1, 2018
Actual Primary Completion Date :	September 1, 2018
Actual Study Completion Date :	January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Early-onset glaucoma Hypertension

MedlinePlus related topics: Dietary Fiber Macular Degeneration

Drug Information available for: Dexamethasone Dexamethasone sodium phosphate Dexamethasone acetate

U.S. FDA Resources

Groups and Cohorts

Intervention Details:

Procedure: intravitreal dexamethasone implant application
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.

Other Name: The Effect of Dexamethasone Implant on Retinal Nerve Fiber and Optic Disc in Diabetic maculopathy.

Outcome Measures

Primary Outcome Measures :

Peripapillary RNFL thickness measurements [ Time Frame: six month ]
micrometer

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	20 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Gender Based Eligibility:	Yes
Gender Eligibility Description:	Individuals over 20 years of age were included in the study.
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Diabetic patient group will be included in the study.

Criteria

Inclusion Criteria

Patients who underwent first time intravitreal injection

Exclusion Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927118

Locations

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Turkey
Zonguldak Bülent Ecevit Üniversitesi.
Zonguldak, Kozlu, Turkey, 67600

Sponsors and Collaborators

Bulent Ecevit University

Investigators

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Study Director:	Atilla Alpay, Ass. Prf.	Zonguldak Bulent Ecevit University

More Information

Publications:

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.

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.

Assmann TS, Brondani LA, Bouças 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. Review.

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.

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.

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. Review.

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.

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.

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.

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.

Ersoy B, Eroğlu N, Çetin M, Onur E, Özkol M, Coşkun Ş. 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.

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.

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Responsible Party:	Atilla Alpay, Associate professor, Bulent Ecevit University
ClinicalTrials.gov Identifier:	NCT03927118
Other Study ID Numbers:	BulentEU2
First Posted:	April 25, 2019 Key Record Dates
Last Update Posted:	May 13, 2019
Last Verified:	May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Atilla Alpay, Bulent Ecevit University:


Diabetic maculopathy dexamethasone implant optic disc vascular endothelial growth factor

Additional relevant MeSH terms:

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Optic Nerve Diseases Macular Edema Ocular Hypertension Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases Cranial Nerve Diseases Nervous System Diseases Dexamethasone Dexamethasone acetate BB 1101 Anti-Inflammatory Agents	Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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