- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03927118
Effect of Dexamethasone Implant on Optic Disc
The Effect of Dexamethasone Implant on Retinal Nerve Fiber and Optic Disc Morphology in Patients With Diabetic Maculopathy
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Kozlu
-
Zonguldak, Kozlu, Turkey, 67600
- Zonguldak Bülent Ecevit Üniversitesi.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peripapillary RNFL thickness measurements
Time Frame: six month
|
micrometer
|
six month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Atilla Alpay, Ass. Prf., Zonguldak Bulent Ecevit University
Publications and helpful links
General 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, 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.
- 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.
- 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, 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Macular Degeneration
- Cranial Nerve Diseases
- Ocular Hypertension
- Macular Edema
- Optic Nerve Diseases
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Dexamethasone
- Dexamethasone acetate
- BB 1101
Other Study ID Numbers
- BulentEU2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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