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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05156021
Other study ID # RuijinHospital
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 12, 2021
Est. completion date December 31, 2022

Study information

Verified date October 2021
Source Ruijin Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
anti-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

Locations

Country Name City State
China Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
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