Neovascular Glaucoma, Proliferative Diabetic Retinopathy
Conditions
Brief summary
With the increasing incidence of proliferative diabetic retinopathy (PDR), subsequent neovascular glaucoma (NVG) has become one of the main causes of blindness in PDR patients, and the intraocular pressure of PDR patients with NVG is often stubborn. For these patients, not only is the effect of drugs in lowering intraocular pressure poor, but the results of surgery are often unsatisfactory. Because of its poor prognosis, clinical research for better strategy is of great significance in the current situation. At present, for such patients, a combination of effective control of intraocular pressure and treatment of the primary disease is often used. The purpose of this study was to investigate the clinical effects of preoperative with/without intraoperative anti-vascular endothelial growth factor (VEGF) drug therapy combined with pars plana vitrectomy (PPV), pan-retinal photocoagulation (PRP), and pressure-reducing valve implantation in patients with NVG secondary to PDR. Furthermore, the changes of neurotrophic factors in the vitreous humor before and after anti-VEGF treatment will be explored.
Interventions
DRUGanti-VEGF
To explore whether adding post-vitrectomy anti-VEGF agent injection can reach a better prognosis in PDR patients with NVG who underwent PPV combined with PRP and pressure-reducing valve implantation
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male or female patients aged over 18 years diagnosed with type 1 or 2 diabetic mellitus (DM) confirmed by experienced endocrinologists. Active PDR and NVG was clinically evident across these patients. The indications to perform surgery included vitreous hemorrhage or fibrous proliferation in the macular area, together with uncontrolled intraocular pressure.
Exclusion criteria
* (i) coexistent ocular disease that may interfere with visual outcome; (ii) previous history of vitrectomy or anti-VEGF pharmacotherapy in either eye; (iii) a macula-involving retinal detachment for \>6 months in the study eye; (iv) severe external ocular infection; (v) usage of anticoagulant or antiplatelet therapy; (vi) preoperative or postoperative poor diabetes control \[serum hemoglobin A1c (HbA1c) \>11.0%\]; (vii) uncontrolled systemic diseases, such as hypertension, cardiac diseases or presenting abnormal coagulation-associated blood diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Best Corrected Visual Acuity from baseline to 12 months after surgery | Follow-up on the first day, first week, 1, 3, 6, 9 and 12 months after surgery |
| Changes in Intraocular Pressure from baseline to 12 months after surgery | Follow-up on the first day, first week, 1, 3, 6, 9 and 12 months after surgery |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Neovascularization Recurrence Rate from baseline to 12 months after surgery | Follow-up on the first day, first week, 1, 3, 6, 9 and 12 months after surgery |
| Changes in Ocular and Systemic Adverse Events from baseline to 12 months after surgery | Follow-up on the first day, first week, 1, 3, 6, 9 and 12 months after surgery |
Countries
China
Outcome results
None listed