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PRP vs PRP+IVC for Severe nPDR

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ClinicalTrials.gov Identifier: NCT03863535
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
Shanghai Municipal Science and Technology Commission
Information provided by (Responsible Party):
Xi Shen, 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.

Condition or disease Intervention/treatment Phase
Severe Nonproliferative Diabetic Retinopathy Diabetic Retinopathy Diabete Mellitus Drug: Conbercept Procedure: Panretinal coagulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 18, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in best-corrected visual acuity (BCVA) [ Time Frame: from baseline to month 12 ]
    To assess the effects of two therapies on visual acuity


Secondary Outcome Measures :
  1. Change in central subfield thickness [ Time Frame: from baseline to month 12 ]
    optical coherence tomography (OCT) for the assessment of central macular thickness

  2. Fundus fluorescein angiography [ Time Frame: from baseline to month 12 ]
    fluorescein angiography to measure area of fluorescein leakage (FLA)

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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03863535


Contacts
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Contact: Xi Shen, MD +86-021-64370045 carl_shen2005@126.com

Locations
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China, Shanghai
Ruijin Hospital Recruiting
Shanghai, Shanghai, China, 20025
Contact: Xi Shen, PhD    +86 136-2167-7680    carl_shen2005@126.com   
Sponsors and Collaborators
Ruijin Hospital
Shanghai Municipal Science and Technology Commission
Investigators
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Study Director: Xi Shen, MD Ruijin Hospital
Principal Investigator: Qiong Zhang, MD Ruijin Hospital

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Responsible Party: Xi Shen, Department director of Ophthamology, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03863535    
Other Study ID Numbers: Ruijin Hospital
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xi Shen, Ruijin Hospital:
Conbercept
Panretinal photocoagulation
non-proliferative diabetic retinopathy
diabetic macular edema
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Diabetes Mellitus
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases