Trials / Unknown
UnknownNCT02911311
Conbercept vs Panretinal Photocoagulation for the Management of Proliferative Diabetic Retinopathy
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 226 (estimated)
- Sponsor
- Sun Yat-sen University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Proliferative diabetic retinopathy (PDR) is a leading cause of vision loss in patients with diabetes mellitus,which of the initial manifestation of PDR is retinal neovascularization at the disc or elsewhere.Panretinal photocoagulation (PRP) has been the standard treatment for PDR since the Diabetic Retinopathy Study demonstrated its benefit nearly 40 years ago,but PRP has inevitable adverse effects on visual function including peripheral visual field defects, night vision loss, loss of contrast sensitivity.Recent evidences have indicated that anti-vascular endothelial growth factor(VEGF) treatment can reduce the severity and delay the progression of DR.However,the impact of this treatment on visual function and the effect of anti-VEGF agents on retinal neovascularization compared with PRP remain unclear. It is possible that a long-acting anti-VEGF agent such as conbercept. So we design the study with is a prospective randomized controlled trial about Intravitreal injection of conbercept versus PRP on PDR.Primary outcome is the change in BCVA from screening to 12 months in the study eye measured in the ETDRS letter score at 4 m
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | intravitreal injection of conbercept | conbercept is an anti-VEGF agent and is approved by the Food and Drug Administration for wet age-related macular degeneration |
| DEVICE | PRP | panretinal photocoagulation (PPR) is the standard treatment for proliferative diabetic retinopathy (PDR) and is applied to the peripheral retinal tissue to ablate areas of the peripheral retina and thereby reduce retinal oxygen consumption |
Timeline
- Start date
- 2019-10-12
- Primary completion
- 2022-12-01
- Completion
- 2022-12-01
- First posted
- 2016-09-22
- Last updated
- 2021-02-25
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02911311. Inclusion in this directory is not an endorsement.