Status:
UNKNOWN
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
Lead Sponsor:
Tianjin Medical University Eye Hospital
Collaborating Sponsors:
AbbVie
Conditions:
Diabetic Macular Edema
Pars Plana Vitrectomy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Diabetic macular edema (DME) is the main cause of severe vision loss in diabetic retinopathy. Intravitreal injection of anti-vascular endothelial growth factor (VEGF) and Ozurdex are two safe and effe...
Eligibility Criteria
Inclusion
- ≥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
- 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
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT05990829
Start Date
October 1 2023
End Date
April 1 2025
Last Update
March 6 2024
Active Locations (1)
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1
Tianjin medical university eye hosipital
Tianjin, Tianjin Municipality, China