Last updated: March 5, 2024
Sponsor: Tianjin Medical University Eye Hospital
Overall Status: Active - Recruiting
Phase
4
Condition
Diabetic Retinopathy
Diabetic Macular Edema
Macular Edema
Treatment
Ozurdex
Aflibercept
Clinical Study ID
NCT05990829
TianjinMUEHhbj001
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- ≥18 years of age;
- Patients and their families fully understand the research and must sign an informedconsent form;
- Patients have a history of diabetes and were diagnosed with PDR by ophthalmicexamination;
- Haemoglobin A1c (HbA1c) levels of <10% within 3 months;
- No contraindication of vitrectomy;
- Pseudophakia or this operation is combined with phacoemulsification and lensimplantation;
- Diagnosed with DME by intraoperative optical coherence tomography during vitrectomy
Exclusion
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 rupturedposterior lens capsule);
- Patients with other retinal diseases (i.e., age-related macular degeneration, retinalvein occlusion);
- Patients received intravitreal Ozurdex three months prior to screening or anti-VEGFinjection one month prior to screening;
- Patients with uncontrolled systemic disease
Study Design
Total Participants: 64
Treatment Group(s): 2
Primary Treatment: Ozurdex
Phase: 4
Study Start date:
October 01, 2023
Estimated Completion Date:
April 01, 2025
Connect with a study center
Tianjin medical university eye hosipital
Tianjin, Tianjin
ChinaActive - Recruiting

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