A Study on the Treatment Strategy of NVG Secondary to PDR

NCT05156021 | Completed

• 1 other identifier: RuijinHospital
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Neovascular Glaucoma; Proliferative Diabetic Retinopathy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

pre-vitrectomy anti-VEGF injection group

EXPERIMENTAL

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

pre and post-vitrectomy anti-VEGF injection group

EXPERIMENTAL

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

Interventions

anti-VEGF DRUG

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

pre and post-vitrectomy anti-VEGF injection group; pre-vitrectomy anti-VEGF injection group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine,

Shanghai, China

Location

MeSH Terms

Conditions

Glaucoma, Neovascular

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Xi Shen

  Ruijin Hospital, Affiliated Shanghai Jiaotong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: December 14, 2021
• Study Start: December 12, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 21, 2023

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)