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CompletedNCT05156021Updated Aug 21, 2023

A Study on the Treatment Strategy of NVG Secondary to PDR

An interventional study of anti-VEGF in Neovascular Glaucoma and Proliferative Diabetic Retinopathy, sponsored by Ruijin Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-21.

Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Neovascular Glaucoma
  • Proliferative Diabetic Retinopathy
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In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 39 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Druganti-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

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What researchers measure

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

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Study locations

1 site
  • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine,
    Shanghai, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05156021
Lead sponsor
Ruijin Hospital
Responsible party
Sponsor
First posted
Dec 14, 2021
Start date
Dec 12, 2021
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022
Last update
Aug 21, 2023

Study contacts

Xi Shen
principal investigator · Ruijin Hospital, Affiliated Shanghai Jiaotong University School of Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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