Pre-vitrectomy Intravitreal Ranibizumab for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Edema

Prospective, Single-blind, Randomised, Controlled, Multi-centre Study to Evaluate the Benefit of Ranibizumab as an Adjunctive Therapy to Vitrectomy for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Oedema

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04464694

Enrollment

142

Registered

2020-07-09

Start date

2020-09-01

Completion date

2022-06-01

Last updated

2020-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema, Proliferative Diabetic Retinopathy

Keywords

PDR, DME, ranibizumab, vitrectomy

Brief summary

To investigate ranibizumab's benefit on prevention of early postoperative vitreous haemorrhage in PDR-DME patients receiving vitrectomy.

Detailed description

Primary Objective: To investigate ranibizumab's benefit on prevention of early postoperative vitreous haemorrhage in PDR-DME patients receiving vitrectomy. Secondary Objective:To investigate ranibizumab's additional benefit on visual improvement, facilitation of surgery and postoperative outcomes in PDR-DME patients receiving vitrectomy. Study design: This study is a prospective, randomized, single-blinded, blank-controlled, multi-center clinical trial that requires vitrectomy for PDR-DME patients.

Interventions

DRUGRanibizumab

Patients will receive single intravitreal injection of Ranibizumab 0.5 mg 3\ 7 days before vitrectomy.

OTHERSham injection

Patients will receive single sham injection 3\ 7 days before vitrectomy.

PROCEDUREPars plana vitrectomy

Surgical procedure to remove the intravitreal hemorrhage and fibrosis membrane, and re-attach the retina, and perform endo laser photocoagulation on retina

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age≥18 years old; 2. Type I or II diabetes mellitus, clinically diagnosed as diabetic macular edema 3. Diagnosed as proliferative diabetic retinopathy and pas plana vitrectomy (PPV) is required to undergo due to non-absorbent vitreous hemorrhage (VH), fibrovascular proliferation with vitreoretinal adhesions or tractional retinal detachment (TRD); or active severe proliferative retinopathy not responding to previous panretinal laser photocoagulation; as well as other indications of PPV at the investigator's discretion 4. Ability to provide written informed consent and comply with study assessments for the full duration of the study.

Exclusion criteria

1. Pregnancy or lactation; 2. History of stroke, peripheral vascular disease, angina or myocardial infarction within six months 3. Intraocular treatment with corticosteroids, anti-vascular endothelium growth factor or intraocular surgery within 45 days preceding baseline; 4. Clinically confirmed intraocular pressure (IOP) \>=21 mmHg, uncontrolled glaucoma or iris neovascularization in either eye

Design outcomes

Primary

Measure	Time frame	Description
Early postoperative vitreous haemorrhage	From day 1 to week 4 after the vitrectomy	To compare the incidence of the early postoperative vitreous haemorrhage between two arms

Secondary

Measure	Time frame	Description
Mean Best-corrected visual acuity (BCVA) at Month 3	Month 3 after vitrectomy	To compare the changes from baseline BCVA to mean BCVA at month 3 between two arms.
Mean Best-corrected visual acuity (BCVA) at Month 6	Month 6 after vitrectomy	To compare the changes from baseline BCVA to mean BCVA at month 6 between two arms.

Countries

China

Contacts

Primary ContactPeiquan Zhao

Zhaopeiquan@126.com13311620396

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026