PRP vs PRP+IVC for Severe nPDR

Study Overview
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Brief Summary
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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
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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.

Official Title
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Panretinal Photocoagulation (PRP) vs PRP Combined With Intravitreous Conbercept (IVC) for Severe Nonproliferative Diabetic Retinopathy (nPDR): A Randomized Clinical Trial

Conditions
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Severe Nonproliferative Diabetic Retinopathy, Diabetic Retinopathy, Diabete Mellitus

Intervention / Treatment
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* Drug: Conbercept
* Procedure: Panretinal coagulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravitreal conbercept+Panretinal coagulation<br> | Drug: Conbercept<br>* Participants were randomized (1:1) to receive IVC+PRP or PRP monotherapy. Patients in IVC+PRP group with diabetic macular edema (DME) received 3 monthly IVC injections along with standard PRP within 1 week after the first injection. Those without DME received 1 lVC injection and standard PRP within 1 week after the injection . Re-treatments in both groups were at the investigators'discretion.<br>Procedure: Panretinal coagulation<br>* The PRP monotherapy group received standard PRP between day 1 and month 2; thereafter, re-treatments in both groups were at the investigators'discretion.<br>|
| Active Comparator: Panretinal coagulation<br> | Procedure: Panretinal coagulation<br>* The PRP monotherapy group received standard PRP between day 1 and month 2; thereafter, re-treatments in both groups were at the investigators'discretion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in best-corrected visual acuity (BCVA) | To assess the effects of two therapies on visual acuity | from baseline to month 12 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Conbercept, Panretinal photocoagulation, non-proliferative diabetic retinopathy, diabetic macular edema