PRP vs PRP+IVC for Severe nPDR

Not Applicable

• Conditions: Severe Nonproliferative Diabetic Retinopathy; Diabete Mellitus; Diabetic Retinopathy
• Interventions: Drug: Conbercept; Procedure: Panretinal coagulation

• Registration Number: NCT03863535
• Lead Sponsor: Ruijin Hospital

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 diabetic macular edema patients.

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 macular edema for a period of 1 year. This was an investigator-initiated study performed by department of ophthalmology, Ruijin hospital affiliated with Shanghai Jiaotong University School of Medicine.

Study Timeline

• Study Start: 2019-01-18
• Study First Submitted: 2019-01-27
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-03
• Last Update Submitted: 2019-03-03
• Study First Posted: 2019-03-05
• Last Update Posted: 2019-03-05
• Primary Completion: 2021-01-01
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Type II diabetic patients, 18 years and older, were included if the participants had:

1. severe non-PDR in either eyes with/without diabetic macular edema;
2. ETDRS letters-measured best-corrected visual acuity (BCVA) ranging from 20/40 to 20/320 Snellen equivalent;
3. no previous treatment (of any type) in either eye.

Exclusion Criteria

1. history of prior laser treatment or vitrectomy in the study eye;
2. history of thromboembolic event - including myocardial infarction or cerebral vascular accident;
3. major surgery within the prior 6 months or planned within the next 28 days;
4. history of glaucoma or ocular hypertension;
5. loss of vision as a result of other causes;
6. history of systemic corticosteroid therapy within the last 3 months;
7. severe systemic disease other than diabetes mellitus;
8. known coagulation abnormalities or current use of anticoagulative medication other than aspirin
9. any condition that could affect followup or documentation (including preretinal or vitreous hemorrhage).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravitreal conbercept+Panretinal coagulation	Panretinal coagulation	-
Panretinal coagulation	Panretinal coagulation	-
Intravitreal conbercept+Panretinal coagulation	Conbercept	-

Primary Outcome Measures

Name	Time	Method
Change in best-corrected visual acuity (BCVA)	from baseline to month 12	To assess the effects of two therapies on visual acuity

Secondary Outcome Measures

Name	Time	Method
Foveal avascular zone	from baseline to month 12	Optical coherence tomography angiography (OCTA) for measurement of FAZ
Change in central subfield thickness	from baseline to month 12	optical coherence tomography (OCT) for the assessment of central macular thickness
Fundus fluorescein angiography	from baseline to month 12	fluorescein angiography to measure area of fluorescein leakage (FLA)

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China