A Study on the Treatment Strategy of NVG Secondary to PDR

Proliferative Diabetic Retinopathy Clinical Trial

Official title:

A Study on the Treatment Strategy of Neovascular Glaucoma Secondary to Proliferative Diabetic Retinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05156021
• Other study ID #: RuijinHospital
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Glaucoma
• Glaucoma, Neovascular
• Neovascular Glaucoma
• Proliferative Diabetic Retinopathy
• Retinal Diseases

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