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

Last updated: January 12, 2024
Sponsor: Sohag University
Overall Status: Active - Recruiting

Phase

1

Condition

Macular Edema

Diabetic Macular Edema

Diabetic Retinopathy

Treatment

Aflibercept Injection [Eylea]

Ranibizumab Injection [Lucentis]

Clinical Study ID

NCT06205979
Soh-Med-23-12-09MS
  • Ages 35-65
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients with type II DM and center involving DME with central foveal thickness morethan 280 um.

Exclusion

Exclusion Criteria:

  1. Evidence of macular ischemia
  2. Evidence of macular traction
  3. Previous intravitreal injections
  4. Previous macular laser therapy
  5. Previous pars plana vitrectomy

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Aflibercept Injection [Eylea]
Phase: 1
Study Start date:
December 12, 2023
Estimated Completion Date:
June 14, 2024

Connect with a study center

  • Sohag university Hospital

    Sohag,
    Egypt

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.