Early Proliferative Diabetic Retinopathy
Conditions
Brief summary
To evaluate the safety and efficacy of intravitreal conbercept after vitrectomy for the management of early-stage proliferative diabetic retinopathy (PDR). Hypothesis: intravitreal conbercept therapy may promote functional and anatomic recovery from PDR. intravitreal conbercept therapy may be a useful and safe method for improving visual outcomes of surgery for early-stage PDR.
Detailed description
The drug conbercept (an anti-vascular endothelial growth factors) was recently made available for management of early prolific diabetic retinopathy, but its safety and efficacy still require study. Therefore, the aim is to evaluate the safety and efficacy of intravitreal conbercept after vitrectomy for the management of early proliferative diabetic retinopathy.The patients were randomly assigned (25 eyes each group) to either treatment group and control after they provided informed consent. The treatment group received intravitreal conbercept (10 mg/mL, 0.5 mg) immediately after surgery, while the control group did not. At the time of study enrollment, physical examinations, best-corrected visual acuity (BCVA), intraocular pressure and central retinal thickness will be measured and fundoscopy be performed. The patients are going to be followed up for at least 6 months via BCVA measurement, fundoscopy, OCT, physical examinations and postoperative complications
Interventions
DRUGConbercept
Three-port 25-G PPV was performed in all patients using a Constellation system. Patients in the treatment group received an intravitreal injection of conbercept (10 mg/mL, 0.5 mg) using a sterile technique after 25-G vitrectomy.
Sponsors
Tianjin Medical University Eye Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
28 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. We enrolled 50 eyes from 50 patients that were affected by VH as a consequence of early active PDR. 2. Patients with non-clearing VH and fibrocellular proliferation without TRD who underwent PPV at Tianjin Medical University Eye Hospital were included in the study.
Exclusion criteria
1. A history of previous PPV; 2. Severe intraoperative complications 3. Postoperative silicone oil tamponade; 4. Menstruation; 5. Stroke, a thromboembolic event, or myocardial infarction in the previous 6. months contraindicating the withdrawal of anti-platelet and anti-coagulant medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| best corrected visual acuity | baseline to 24 weeks post-surgery | BCVA using a Landolt C acuity chart method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative complications | baseline to 24 weeks post-surgery | postoperative complications |
| central retinal thickness | baseline to 24 weeks post-surgery | Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture micrometer-resolution, one-dimensional images |
Outcome results
None listed