Treatment for non-tractional refractory diabetic macular edema using vitrectomy and subretinal injection
Comparative Study Between Pars Plana Vitrectomy With Internal Limiting Membrane Peeling With or Without Planned Foveal Detachment for Management of Non-tractional Refractory Diabetic Macular Edema
This study is testing a new surgery combined with an injection to see if it can help people with stubborn diabetic eye swelling improve their vision and reduce eye swelling.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 2 sites (Cairo and 1 other locations) |
| Trial ID | NCT06271473 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of a combined approach involving pars plana vitrectomy and internal limiting membrane peeling, with or without a planned foveal detachment through subretinal injection of Ringer's solution, in patients suffering from non-tractional refractory diabetic macular edema. The intervention aims to enhance the clearance of vascular endothelial growth factor (VEGF) and other cytokines from the retina, thereby improving retinal oxygenation and reducing diabetic macular edema. Participants will be monitored for visual acuity and central macular thickness to assess treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals over 40 years old with type 2 diabetes for more than 5 years and specific visual acuity and central macular thickness criteria.
Not a fit: Patients with other causes of macular edema or those with severe retinal damage or complications may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve vision and quality of life for patients with refractory diabetic macular edema.
How similar studies have performed: While similar approaches have been explored, this specific combination of techniques is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: above 40 years old. * Patients with type two diabetes mellitus of more than 5 years duration. * Patients with Best corrected visual acuity better than 3/60. * Central macular thickness (CMT) of more than 250 μm despite undergoing six monthly injection of anti-VEGF therapy or corticosteroid or less than 10% reduction in CMT at the last follow up visit. * No evidence of vitreomacular traction. * Lens status: Pseudophakia or clear crystalline lens. Exclusion Criteria: Other causes of macular edema (intraocular inflammation, retinal vein occlusion, Irvin-gass syndrome, pharmacological). * Ischemic maculopathy by FFA. * Presence of bad prognostic signs in OCT such as disorganization of inner retinal layers (DRIL) and extensive disruption of IS-OS junction subfoveally. * Presence of apparent retinal pigment epithelium (RPE) atrophy at or near the macula. * Presence of proliferative diabetic fibrovascular membranes threatening or at the macula. * Presence of diabetic optic atrophy or neuropathy. * Presence of neovascular glaucoma. * Cataractous lens either preoperatively or as intra or postoperative complication. * Vitrectomized Eyes. * A prior intraocular surgery within the past six-months. * Lost follow up
Where this trial is running
Cairo and 1 other locations
- Ain Shams university — Cairo, Egypt (Active_not_recruiting)
- Ain Shams university — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Abdelrahman G Salman, MD — professor at Ain Shams university
- Study coordinator: Azza MA Said, MD
- Email: dr_azza_22@hotmail.com
- Phone: 2001006228992
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.