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NCT05248334

A Prospective Study of Ranibizumab in the Treatment of Postoperative Recurrent Vitreous Haemorrhage of Diabetic Retinopathy

Status unknown Phase 1 Last updated 12 August 2022
What this trial tests

Phase 1 trial testing Ranibizumab Injection in Diabetic Retinopathy in 120 participants. Status unknown.

Timeline
10 April 2022
Primary endpoint
30 December 2024
30 December 2024

Quick facts

Lead sponsorTianjin Medical University Eye Hospital
PhasePhase 1
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment120
Start date10 April 2022
Primary completion30 December 2024
Estimated completion30 December 2024
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Tianjin Medical University Eye Hospital

Who can join

Adults 18 to 75, any sex, with Diabetic Retinopathy or Postoperative Recurrent Vitreous Hemorrhage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Diabetic retinopathy (DR) is one of the main complications in diabetes, the proliferative diabetic retinopathy (PDR) is the most important one of the reasons leading to decreased vision, PDR is the stage of clinical intervention. Pars plana vitrectomy (PPV) is an effective treatment for PDR, while vitreous haemorrhage (VH) is a common complication after PPV, with incidence ranging from 11.8% to 75%, and is the main cause of reoperation. Anti-Vascular endothelial growth factor (VEGF) therapy for vitreous hemorrhage can inhibit neovascularization and prevent recurrent vitreous haemorrhage after absorption. Previous studies have found that anti-VEGF is a safe and effective treatment for postoperative recurrent VH. In consideration of the psychological and economic factor of patients, this study intends to observe the effectiveness of single vitreous injection of Ranibizumab in the treatment of postoperative recurrent VH on the basis of previous clinical work. Compare the visual acuity, macular thickness, VH recurrence and patient satisfaction between the Ranibizumab group and the PPV group by randomized grouping.To observe the effective rate and clearance time of recurrent VH after Ranibizumab treatment and whether it can effectively reduce the rate of PPV. To provide clinical guidance for the precise treatment of PDR patients, the treatment of PDR patients has important clinical significance and social and economic significance.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Intravitreal Ranibizumab versus Vitreous Lavage for Postoperative Vitreous Hemorrhage in Proliferative Diabetic Retinopathy: A Randomized Controlled Trial.
    Chi J, Zhang X, Nie Z, Pan Y, et al · · 2026 · PMID 41858910 · DOI 10.2147/dddt.s557400

Verify or expand the search:

Other trials of Ranibizumab Injection

Trials testing the same drug.

Other recruiting trials for Diabetic Retinopathy

Currently open trials in the same condition.

Other Tianjin Medical University Eye Hospital trials

Trials by the same sponsor.

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