NCT05248334

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 10, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

August 12, 2022

Status Verified

February 1, 2022

Enrollment Period

2.7 years

First QC Date

February 7, 2022

Last Update Submit

August 11, 2022

Conditions

Diabetic RetinopathyPostoperative Recurrent Vitreous HemorrhagePars Plana VitrectomyRanibizumab

Outcome Measures

Primary Outcomes (2)

  • The cleaning time of postoperative recurrent vitreous hemorrhage

    Record VH by B scan and funds examination

    two months

  • Visual acuity

    ETDRS Alphabet Chart

    six moths

Secondary Outcomes (3)

  • Macular thickness

    six moths

  • Vitreous hemorrhage recurrence

    six moths

  • The number of pars plana vitrectomy

    six moths

Study Arms (2)

Ranibizumab group

EXPERIMENTAL

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.

Drug: Ranibizumab Injection

PPV group

ACTIVE COMPARATOR

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.

Procedure: PPV

Interventions

Ranibizumab InjectionDRUG

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.

Also known as: Panretinal photocoagulation
Ranibizumab group
PPVPROCEDURE

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.

Also known as: Panretinal photocoagulation
PPV group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntary and able to sign an informed consent form
  • Age ≥18 years
  • Documented diagnosis of diabetes mellitus (type I or type II diabetes) as defined by the American Diabetes Association or World Health Organization criteria and glycosylated hemoglobin ≤10% within 2 months
  • Willing and able to complete all planned visits and evaluations
  • Complete Panretinal photocoagulation
  • Retinal repositioning
  • Complete postoperative vitreous hemorrhage clearance for more than 1 week and non-absorption of recurrent vitreous hemorrhage for more than 4 weeks (grade 2 and above)
  • Early postoperative period (1 week to 1 month postoperatively) and delayed postoperative period (4 weeks to 12 months postoperatively)

You may not qualify if:

  • Patients with less than 6 months of follow-up
  • Silicone oil filling
  • Other retinal causes of vitreous hemorrhage
  • Tractive retinal detachment, pre-retinal proliferative membrane
  • Iris redness, neovascular glaucoma
  • History of glaucoma
  • Ocular inflammation
  • Any other intraocular surgery (e.g., corneal transplantation, glaucoma filtration, corneal transplantation therapy, etc.)
  • Patients with best corrected visual acuity manual or worse, patients with a single eye
  • Previous cerebrovascular or thromboembolic events, hypertensive disorders, renal disease, current use of anticoagulants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin medical university eye hosipital

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Bojie Hu

CONTACT

13612130943bhu07@tmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 7, 2022

First Posted

February 21, 2022

Study Start

April 10, 2022

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

August 12, 2022

Record last verified: 2022-02

Locations

CN(1)