Status:
COMPLETED
Efficacy and Safety Comparison of IVR and IVC Before Vitrectomy in Proliferative Diabetic Retinopathy
Lead Sponsor:
Peking University People's Hospital
Conditions:
Proliferative Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Proliferative diabetic retinopathy (PDR) is the most common causes of irreversible blindness in diabetic retinopathy (DR).Although pars plana vitrectomy (PPV) is the cornerstone for treatment of advan...
Detailed Description
Proliferative diabetic retinopathy (PDR) is the most common causes of irreversible blindness in diabetic retinopathy (DR).It is characterized by progressive loss of vision, retinal edema, vitreous hem...
Eligibility Criteria
Inclusion
- patients aged 18 years or more with type 1 or 2 diabetes who were clinically diagnosed with diabetic retinopathy (DR); hemoglobin A1c (HbA1c) ≤ 12%;
- persistent VH for more than 1 month or recurrent vitreous hemorrhage (VH) with or without panretinal photocoagulation (PRP);
- TRD detected by indirect ophthalmoscope or B-scan ultrasonography.
Exclusion
- previous vitreoretinal surgeries (including vitrectomy, intravitreal drug injection) in the study eyes;
- eyes with any ocular disease that may hinder visual improvement other than PDR, such as optic atrophy or macular hole;
- history of thromboembolic events (including cerebral vascular infarctions or myocardial infarctions) or coagulation system disorders or receiving anticoagulant or antiplatelet therapy;
- eyes given gas tamponade or additional treatment like ranibizumab injection again or supplementary retinal photocoagulation during follow-up periods.
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05414149
Start Date
September 1 2021
End Date
May 31 2022
Last Update
June 10 2022
Active Locations (1)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044