A Study on the Treatment Strategy of NVG Secondary to PDR

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

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.

Study Overview

• Status: Completed
• Conditions: Proliferative Diabetic Retinopathy; Neovascular Glaucoma
• Intervention / Treatment: Drug: anti-VEGF

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pre-vitrectomy anti-VEGF injection group; Patient in this group receive an intravitreal injection of anti-VEGF drug 3-5 days before surgery, followed by PPV combined with PRP and pressure-reducing valve implantation	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
Experimental: pre and post-vitrectomy anti-VEGF injection group; Patient in this group receive two intravitreal injections of anti-VEGF drugs. One is injected 3-5 days before surgery, the other is at the same time as the PPV combined with PRP and pressure reducing valve implantation is completed.	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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Principal Investigator: Xi Shen, Ruijin Hospital, Affiliated Shanghai Jiaotong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: December 13, 2021
• First Posted (Actual): December 14, 2021

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Ocular Hypertension; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Glaucoma; Retinal Diseases; Diabetic Retinopathy; Glaucoma, Neovascular
• Other Study ID Numbers: RuijinHospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No