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A Study on the Treatment Strategy of NVG Secondary to PDR

Primary Purpose

Neovascular Glaucoma, Proliferative Diabetic Retinopathy

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
anti-VEGF
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

pre-vitrectomy anti-VEGF injection group

pre and post-vitrectomy anti-VEGF injection group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Changes in Best Corrected Visual Acuity from baseline to 12 months after surgery
Changes in Intraocular Pressure from baseline to 12 months after surgery

Secondary Outcome Measures

Changes in Neovascularization Recurrence Rate from baseline to 12 months after surgery
Changes in Ocular and Systemic Adverse Events from baseline to 12 months after surgery

Full Information

First Posted
October 14, 2021
Last Updated
August 17, 2023
Sponsor
Ruijin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05156021
Brief Title
A Study on the Treatment Strategy of NVG Secondary to PDR
Official Title
A Study on the Treatment Strategy of Neovascular Glaucoma Secondary to Proliferative Diabetic Retinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
December 12, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Glaucoma, Proliferative Diabetic Retinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pre-vitrectomy anti-VEGF injection group
Arm Type
Experimental
Arm Description
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
Arm Title
pre and post-vitrectomy anti-VEGF injection group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
anti-VEGF
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in Best Corrected Visual Acuity from baseline to 12 months after surgery
Time Frame
Follow-up on the first day, first week, 1, 3, 6, 9 and 12 months after surgery
Title
Changes in Intraocular Pressure from baseline to 12 months after surgery
Time Frame
Follow-up on the first day, first week, 1, 3, 6, 9 and 12 months after surgery
Secondary Outcome Measure Information:
Title
Changes in Neovascularization Recurrence Rate from baseline to 12 months after surgery
Time Frame
Follow-up on the first day, first week, 1, 3, 6, 9 and 12 months after surgery
Title
Changes in Ocular and Systemic Adverse Events from baseline to 12 months after surgery
Time Frame
Follow-up on the first day, first week, 1, 3, 6, 9 and 12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xi Shen
Organizational Affiliation
Ruijin Hospital, Affiliated Shanghai Jiaotong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine,
City
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study on the Treatment Strategy of NVG Secondary to PDR

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