Status:
UNKNOWN
PRP vs PRP+IVC for Severe nPDR
Lead Sponsor:
Ruijin Hospital
Collaborating Sponsors:
Shanghai Municipal Science and Technology Commission
Conditions:
Severe Nonproliferative Diabetic Retinopathy
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The randomized clinical trial aims to compare the therapeutic effects between panretinal photocoagulation(PRP) and PRP combined with intravitreal conbercept (IVC) injection in severe nPDR with/without...
Detailed Description
This was a prospective, randomized, two-armed study to assess the efficacy and safety of intravitreal conbercept injection plus PRP versus PRP in the treatment of nPDR patients with/without diabetic m...
Eligibility Criteria
Inclusion
- Type II diabetic patients, 18 years and older, were included if the participants had:
- severe non-PDR in either eyes with/without diabetic macular edema;
- ETDRS letters-measured best-corrected visual acuity (BCVA) ranging from 20/40 to 20/320 Snellen equivalent;
- no previous treatment (of any type) in either eye.
Exclusion
- history of prior laser treatment or vitrectomy in the study eye;
- history of thromboembolic event - including myocardial infarction or cerebral vascular accident;
- major surgery within the prior 6 months or planned within the next 28 days;
- history of glaucoma or ocular hypertension;
- loss of vision as a result of other causes;
- history of systemic corticosteroid therapy within the last 3 months;
- severe systemic disease other than diabetes mellitus;
- known coagulation abnormalities or current use of anticoagulative medication other than aspirin
- any condition that could affect followup or documentation (including preretinal or vitreous hemorrhage).
Key Trial Info
Start Date :
January 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03863535
Start Date
January 18 2019
End Date
September 30 2021
Last Update
March 5 2019
Active Locations (1)
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1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 20025