PRP vs PRP+IVC for Severe nPDR

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03863535
• Other study ID #: Ruijin Hospital
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: March 2019
• Source: Ruijin Hospital
• Contact: Xi Shen, MD
• Phone: +86-021-64370045
• Email: carl_shen2005[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 30, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabete Mellitus
• Diabetes Mellitus
• Diabetic Retinopathy
• Retinal Diseases
• Severe Nonproliferative Diabetic Retinopathy

Intervention

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.

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Ruijin Hospital	Shanghai Municipal Science and Technology Commission

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in best-corrected visual acuity (BCVA)	To assess the effects of two therapies on visual acuity	from baseline to month 12
Secondary	Change in central subfield thickness	optical coherence tomography (OCT) for the assessment of central macular thickness	from baseline to month 12
Secondary	Fundus fluorescein angiography	fluorescein angiography to measure area of fluorescein leakage (FLA)	from baseline to month 12
Secondary	Foveal avascular zone	Optical coherence tomography angiography (OCTA) for measurement of FAZ	from baseline to month 12