Comparing two treatments for diabetic macular edema during eye surgery
Compare the Efficacy of VItrectomy Combined With DExamethasone Implant Versus With Aflibercept in DME Patients Diagnosed by Intraoperative OCT (the VIDEO Study): Study Protocol for a Randomized Controlled Trial
This study is testing whether a dexamethasone implant or aflibercept works better for treating diabetic macular edema during eye surgery for patients with proliferative diabetic retinopathy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tianjin Medical University Eye Hospital Academic / other |
| Locations | 1 site (Tianjin, Tianjin) |
| Trial ID | NCT05990829 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of two treatment approaches for diabetic macular edema (DME) during pars plana vitrectomy (PPV) using intraoperative optical coherence tomography (OCT) for diagnosis. Patients diagnosed with DME during surgery will receive either a dexamethasone implant (Ozurdex) or aflibercept, an anti-VEGF therapy. The study will evaluate the prognosis and outcomes of these two treatment methods in patients with proliferative diabetic retinopathy (PDR). By utilizing intraoperative OCT, the study seeks to provide clearer insights into retinal conditions that may complicate treatment.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a history of diabetes and diagnosed with proliferative diabetic retinopathy and diabetic macular edema.
Not a fit: Patients with other retinal diseases or those who have had recent intravitreal treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes for patients with diabetic macular edema undergoing eye surgery.
How similar studies have performed: While there have been studies on treatments for diabetic macular edema, the specific combination of intraoperative OCT with these treatment methods is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥18 years of age; * Patients and their families fully understand the research and must sign an informed consent form; * Patients have a history of diabetes and were diagnosed with PDR by ophthalmic examination; * Haemoglobin A1c (HbA1c) levels of \<10% within 3 months; * No contraindication of vitrectomy; * Pseudophakia or this operation is combined with phacoemulsification and lens implantation; * Diagnosed with DME by intraoperative optical coherence tomography during vitrectomy Exclusion Criteria: * The follow-up period is less than 6 months; * Patients need gas or silicon oil tamponade; * Patients with rubeosis iridis, neovascular glaucoma and endophthalmitis; * Patients with other intraocular surgeries (except cataract surgery with no ruptured posterior lens capsule); * Patients with other retinal diseases (i.e., age-related macular degeneration, retinal vein occlusion); * Patients received intravitreal Ozurdex three months prior to screening or anti-VEGF injection one month prior to screening; * Patients with uncontrolled systemic disease
Where this trial is running
Tianjin, Tianjin
- Tianjin medical university eye hosipital — Tianjin, Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Bojie Hu
- Email: bhu07@tmu.edu.cn
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.