PRP vs PRP+IVC for Severe nPDR

Sponsor

Ruijin Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03863535

Collaborator

Shanghai Municipal Science and Technology Commission (Other)

Enrollment

Location

Arms

32.4

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Nonproliferative Diabetic Retinopathy Diabetic Retinopathy Diabete Mellitus	Drug: Conbercept Procedure: Panretinal coagulation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 18, 2019

Anticipated Primary Completion Date :

Jan 1, 2021

Anticipated Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intravitreal conbercept+Panretinal coagulation	Drug: Conbercept 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. Procedure: Panretinal coagulation The PRP monotherapy group received standard PRP between day 1 and month 2; thereafter, re-treatments in both groups were at the investigators'discretion.
Active Comparator: Panretinal coagulation	Procedure: Panretinal coagulation The PRP monotherapy group received standard PRP between day 1 and month 2; thereafter, re-treatments in both groups were at the investigators'discretion.

Arm

Intervention/Treatment

Experimental: Intravitreal conbercept+Panretinal coagulation

Drug: Conbercept

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.

Procedure: Panretinal coagulation

The PRP monotherapy group received standard PRP between day 1 and month 2; thereafter, re-treatments in both groups were at the investigators'discretion.

Active Comparator: Panretinal coagulation

Procedure: Panretinal coagulation

The PRP monotherapy group received standard PRP between day 1 and month 2; thereafter, re-treatments in both groups were at the investigators'discretion.

Outcome Measures

Primary Outcome Measures

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

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)
Foveal avascular zone [from baseline to month 12]
Optical coherence tomography angiography (OCTA) for measurement of FAZ

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).