Examining how cholesterol levels affect treatment response in diabetic eye disease
Relationship Between Dyslipidemia and The Response of Diabetic Macular Edema to Intravitreal Injection of Anti Vascular Endothelial Growth Factor Agents
This study is testing if cholesterol levels affect how well anti-VEGF injections work for people with diabetic eye disease.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 35 Years to 65 Years |
| Sex | All |
| Sponsor | Sohag University Academic / other |
| Drugs / interventions | Ranibizumab |
| Locations | 1 site (Sohag) |
| Trial ID | NCT06205979 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between dyslipidemia and the effectiveness of anti-VEGF injections in treating diabetic macular edema (DME). It focuses on patients with type II diabetes who have DME characterized by a central foveal thickness greater than 280 micrometers. The study aims to determine if cholesterol levels influence the response to treatments like Ranibizumab and Aflibercept, which are designed to reduce retinal edema and preserve vision. By understanding this relationship, the study seeks to optimize treatment strategies for patients suffering from DME.
Who should consider this trial
Good fit: Ideal candidates are patients with type II diabetes and center-involving diabetic macular edema with a central foveal thickness greater than 280 micrometers.
Not a fit: Patients with macular ischemia, macular traction, or those who have previously undergone intravitreal injections, macular laser therapy, or pars plana vitrectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients with diabetic macular edema.
How similar studies have performed: While the relationship between dyslipidemia and treatment response in DME is not extensively studied, similar approaches in other conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients with type II DM and center involving DME with central foveal thickness more than 280 um. 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
Where this trial is running
Sohag
- Sohag university Hospital — Sohag, Egypt (Recruiting)
Study contacts
- Study coordinator: Ola G Ameen, resident
- Email: ola011117@med.sohag.edu.eg
- Phone: 01009507654
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.