PRP vs PRP+IVC for Severe nPDR

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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetic Retinopathy; Diabete Mellitus; Severe Nonproliferative Diabetic Retinopathy
• Intervention / Treatment: Drug: Conbercept; Procedure: Panretinal coagulation

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 20025
      • Recruiting
      • Ruijin Hospital
      • Contact: Xi Shen, PhD; Phone Number: +86 136-2167-7680; Email: carl_shen2005@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: Shanghai Municipal Science and Technology Commission
• Investigators: Study Director: Xi Shen, MD, Ruijin Hospital; Principal Investigator: Qiong Zhang, MD, Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2019
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: January 27, 2019
• First Submitted That Met QC Criteria: March 3, 2019
• First Posted (Actual): March 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 5, 2019
• Last Update Submitted That Met QC Criteria: March 3, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: diabetic macular edema; Conbercept; non-proliferative diabetic retinopathy; Panretinal photocoagulation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: Ruijin Hospital

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No