Conbercept vs Panretinal Photocoagulation for the Management of Proliferative Diabetic Retinopathy

• Status: Enrolling by invitation
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Panretinal photocoagulation (PRP) has been the standard treatment for Proliferative diabetic retinopathy (PDR) since the Diabetic Retinopathy Study demonstrated its benefit nearly 40 years ago,but PRP has inevitable adverse effects on visual function. Intravitreal injection of vascular endothelial growth factor(VEGF) can induce short-term regression of retinal neovascularization(NV). The purpose is to assess and compare the efficacy and safety between intravitreal injection of conbercept and PRP.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University

Criteria

Inclusion Criteria:

1. Participants of either sex aged 18 years or over.

2. Diagnosis of diabetes mellitus (type 1 or 2).

3. Best-corrected visual acuity (BCVA) in the study eye better than or equal to 30 Early Treatment Diabetic Retinopathy Study (ETDRS) letters

4. PDR with no evidence of previous PRP.

5. Media clarity, pupillary dilation and participant cooperation sufficient for adequate fundus photographs.

Exclusion Criteria:

1. a glycated haemoglobin (HbA1c) level of more than 10%;

2. Blood pressure > 180/100 mmHg

3. Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 6 months

4. dialysis or renal transplant

5. Systemic anti-VEGF or pro-VEGF treatment within 6 months prior to randomization

6. For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years

7. Traction retinal detachment involving the macula

8. Exam evidence of neovascularization of the angle

9. History of major ocular surgery or anticipated within the next 6 months following randomization