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

Sponsor
Tianjin Medical University Eye Hospital
Study ID
NCT05248334
Phase
PHASE1
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab Injection — DRUG
    The Ranibizumab group was treated with one intravitreal injection of 0.5 mg/0.05 ml ranibizumab (Lucentis, Basel, Novartis) at baseline. While additional panretinal photocoagulation was performed if there was sufficient space and view to fill in the previously untreated areas, if needed. Repeated injections will be given after 4 weeks when the clearing of VH was incomplete (for a maximum of two injections). If vitreous hemorrhage was not absorbed/vitreous hemorrhage aggravation/proliferation membrane formation/retinal detachment after 4 weeks of observation, the treatment was considered failed and PPV was performed.
  • PPV — PROCEDURE
    Vitrectomy to remove vitreous hemorrhage and take additional panretinal photocoagulation. If vitreous hemorrhage was not absorbed/vitreous hemorrhage aggravation/proliferation membrane formation/tractive retinal detachment after 4 weeks of observation, the treatment was considered failed and PPV was performed.

Study Details

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.

Key Dates

First listed
Feb 21, 2022
Start date
Apr 10, 2022
Status verified
Feb 2022
Primary completion
Dec 30, 2024
Completion
Dec 30, 2024

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ranibizumab group
    The Ranibizumab group was treated with one intravitreal injection of 0.5 mg/0.05 ml ranibizumab (Lucentis, Basel, Novartis) at baseline. While additional panretinal photocoagulation was performed if there was sufficient space and view to fill in the previously untreated areas, if needed. Repeated injections will be given after 4 weeks when the clearing of VH was incomplete (for a maximum of two injections). If vitreous hemorrhage was not absorbed/vitreous hemorrhage aggravation/proliferation membrane formation/retinal detachment after 4 weeks of observation, the treatment was considered failed and PPV was performed.
  • Active Comparator: PPV group
    Vitrectomy to remove vitreous hemorrhage and take additional panretinal photocoagulation. If vitreous hemorrhage was not absorbed/vitreous hemorrhage aggravation/proliferation membrane formation/tractive retinal detachment after 4 weeks of observation, the treatment was considered failed and PPV was performed.

Primary Outcome Measure

The cleaning time of postoperative recurrent vitreous hemorrhage [ Time Frame: two months ]

Central Contacts

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