NCT06205979

Relationship Between Dyslipidemia and The Response of Diabetic Macular Edema to Intravitreal Injection of Anti Vascular Endothelial Growth Factor Agents

Sohag University·Phase 1·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Diabetic Macular Edema
Drug/Device/Intervention
Ranibizumab Injection [Lucentis]
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Sohag University
Location
Sohag, Egypt
Timeline & enrollment
Phase
Phase 1
Start date
Dec 12, 2023
End date
Jun 14, 2024
Enrollment
50 participants
Primary outcome

change in the best corrected visual acuity in meters,change in the retina and macula measurements by Optical coherence tomography (OCT),change in the retina and macula measurements by Optical coherence tomography (OCT),change in the retina and macula measurements by Optical coherence tomography (OCT)

Summary

Diabetic retinopathy (DR) is considered the main etiology of blindness among working-age
 adults, and Diabetic macular edema (DME) is the main reason for vision loss related to DR .
 Retinal oedema is responsible for retinal micro-structural alterations, retinal atrophy of
 photoreceptors and ganglion cell disorders . In addition, it might be considered consensual
 that the best improvements in VA could be accomplished when retinal oedema is managed. In the
 context of a chronic and progressive disease, DME has to be faced as a state to control as
 effectively and rapidly as possible . Vascular endothelial growth factor (VEGF) is a protein
 that promotes the growth of new blood vessels. It also makes the blood vessels more leaky.
 Anti- VEGF medicines stop the growth of these new blood vessels. This prevents damage to the
 retinal light receptors and loss of central vision. The DME treatment has been shifted from
 the laser photocoagulation to anti-VEGF therapy . The advantages of anti-VEGF therapy in
 decreasing DME and improving patient's vision have been reported in many studies .
 Ranibizumab, in addition to aflibercept, have been reported as the first line therapies among
 the other anti-VEGF . There are several data demonstrating the efficiency of ranibizumab in
 treatment of patients with DME . On the other hand, there are studies that revealed poor
 response of some patients to anti-VEGF therapies even after 3 or more injections
 Non-modifiable risk factors for diabetic retinopathy are gender and DM duration.
 
 Modifiable risk factors contributing to the development of diabetic retinopathy are elevated
 blood sugar levels, blood pressure, and dyslipidemia which is the imbalance of lipids such as
 cholesterol, low-density lipoprotein cholesterol, (LDL-C), triglycerides, and high-density
 lipoprotein (HDL). This condition can result from diet, tobacco exposure, or genetic . Hard
 exudates are thought to be induced by the leakage of lipids from dysfunctional retinal
 capillaries . Therefore, theses were formulated that higher levels of total cholesterol,
 LDL-C and triglycerides could be considered biomarkers of the development of hard exudates in
 DM patients . Aim of the work
 
 - Correlate between dyslipidemia and the response of patients with diabetic macular oedema to
 intravitreal anti-VEGF injection

ICD-10 classifications
Diabetic retinopathyOther specified diabetes mellitus with ophthalmic complicationsUnspecified diabetes mellitus with ophthalmic complicationsDiabetic cataractType 2 diabetes mellitus with ophthalmic complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06205979
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06205979 through Pure Global AI's free database. This Phase 1 trial is sponsored by Sohag University and is currently Recruiting. The study focuses on Diabetic Macular Edema. Target enrollment is 50 participants.

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