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NCT Number: NCT05156021

A Study on the Treatment Strategy of NVG Secondary to PDR

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.

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Key information

Conditions

Neovascular Glaucoma Eye Diseases Glaucoma Glaucoma, Neovascular Ocular Hypertension Proliferative Diabetic Retinopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine,

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 14, 2021
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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