diabetic retinopathy
Conditions
Interventions
IVC+PRP group:Standard PRP therapy was followed by intravitreal injection (IVC) of compacept
PRP+IVC group:The standard PRP is given before intravitreal conbercept
Sponsors
The Second Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years; 2. Diagnosis of type 1 or type 2 diabetes mellitus with diabetic retinopathy (DRSS 47-75); 3. The score of ETDRS visual acuity chart for the study of optimal corrected visual acuity is >=24 letters (equivalent to Snellen visual acuity chart 20/320 and above); 4. Able to sign informed consent and cooperate with inspection.
Exclusion criteria
Exclusion criteria: 1. Prior retinal photocoagulation in the study eye (including panretinal and focal/grid photocoagulation); 2. Prior systemic anti-VEGF treatment or IVT anti-VEGF treatment in the study eye; 3. Prior intraocular steroid injection in the study eye; 4. History of vitreoretinal surgery or other ocular surgery within the prior 6 months (including cataract surgery, any intraocular surgery) in the study eye; 5. Ocular media of insufficient quality to obtain fundus and optical coherence tomography (OCT) images in the study eye; 6. Diagnosed as glaucoma or suspected glaucoma in the study eye; 7. An ocular condition (other than diabetes) is present in the study eye that might alter visual acuity during the course of the study (eg, retinal vein occlusion, uveitis or other ocular inflammatory disease); 8. Hemoglobin A1c (HbA1c) >12%, or diabetes mellitus is uncontrolled in the opinion of the investigator; 9. Systolic blood pressure >=180 mmHg or diastolic blood pressure >=110 mmHg; 10. Renal failure, dialysis, or history of renal transplant; 11. History of cerebrovascular accident or myocardial infarction within the prior 6 months; 12. Pregnancy or women who are lactating or intending to become pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants in both treatment groups who improved >= grade 2 of the ETDRS diabetic Retinopathy severity scale (DRSS) from baseline to the end of 12-month follow-up; | — |
Secondary
| Measure | Time frame |
|---|---|
| Best-corrected visual acuity;Central macular thickness;Visual field sensitivity;Changes of factors related to inflammation, neovascularization and fibrosis in serum and aqueous humor;The proportion of patients who have regression of neovascularization;Number of treatments; | — |
Countries
China
Contacts
Public ContactZhou Aiyi
The Second Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed