Diabete Mellitus, Diabetic Retinopathy, Severe Nonproliferative Diabetic Retinopathy
Conditions
Keywords
Conbercept, Panretinal photocoagulation, non-proliferative diabetic retinopathy, diabetic macular edema
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.
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.
Interventions
DRUGConbercept
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.
PROCEDUREPanretinal 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.
Sponsors
Shanghai Municipal Science and Technology Commission
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in best-corrected visual acuity (BCVA) | from baseline to month 12 | To assess the effects of two therapies on visual acuity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in central subfield thickness | from baseline to month 12 | optical coherence tomography (OCT) for the assessment of central macular thickness |
| Fundus fluorescein angiography | from baseline to month 12 | fluorescein angiography to measure area of fluorescein leakage (FLA) |
| Foveal avascular zone | from baseline to month 12 | Optical coherence tomography angiography (OCTA) for measurement of FAZ |
Countries
China
Contacts
Primary ContactXi Shen, MD
Outcome results
None listed