Safety and Efficacy of Intravitreal Ranibizumab as a Preoperative Adjunct Treatment Before Vitrectomy Surgery in Proliferative Diabetic Retinopathy (PDR) Compared to Vitrectomy Alone

NCT ID: NCT00931125

Last Updated: 2013-10-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2013-12-31

Brief Summary

This study investigates the hypothesis that ranibizumab injection given into the eye is a safe, efficacious and helping treatment option applied before surgical intervention of the proliferative diabetic retinal eye disorder.

Detailed Description

This is a randomized, double blinded , controlled, two-center study assessing the feasibility, efficacy and safety of intravitreal ranibizumab injection applied as a preoperative adjunct treatment before vitrectomy surgery in severe proliferative diabetic retinopathy (PDR). Comparator arm consists of patients receiving standard vitrectomy alone with sham intravitreal injection preoperatively.

Conditions

Diabetic Retinopathy

Keywords

Severe proliferative diabetic retinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

vitrectomy with ranibizumab

Patients receiving adjunct preoperative intravitreal ranibizumab (3±1 days) before vitrectomy surgery

Group Type: ACTIVE_COMPARATOR

ranibizumab and vitrectomy

Intervention Type: DRUG

ranibizumab 10mg/ml intravitreal injection, 0,05 ml

vitrectomy without ranibizumab

Patients receiving sham treatment before vitrectomy as a comparator arm

Group Type: PLACEBO_COMPARATOR

vitrectomy without preoperative ranibizumab

Intervention Type: PROCEDURE

sham intravitreal injection before vitrectomy surgery

Interventions

ranibizumab and vitrectomy

ranibizumab 10mg/ml intravitreal injection, 0,05 ml

Intervention Type: DRUG

vitrectomy without preoperative ranibizumab

sham intravitreal injection before vitrectomy surgery

Intervention Type: PROCEDURE

Other Intervention Names

Lucentis intravitreal injection.

Eligibility Criteria

Inclusion Criteria

• male or female 18 or older who have signed an informed consent
• Type I or II diabetes mellitus and severe proliferative retinopathy with tractional retinal detachment, tractional-rhegmatogenous retinal detachment, tractional detachment complicated with vitreous haemorrhage or active severe proliferative retinopathy not responding to previous panretinal laser photocoagulation
• study eye BCVA must have at least light perception and must not exceed 70 letters using ETDRS at testing distance 4 meters
• study eye vision decrease must be resulted from severe PDR

Exclusion Criteria

• Active ocular inflammation or infection
• History of uveitis
• Uncontrolled glaucoma
• High myopia
• Any concurrent intraocular condition in the study eye that in the opinion of the investigator could confound the study results
• Former treatment with anti-angiogenic drugs within 30 days preceding Day 1 in the study eye
• History of vitrectomy within 60 days preceding Day 1 in the study eye
• History of intraocular surgery within 30 days preceding Day 1 in the study eye
• Untreated diabetes mellitus
• Severe hypertension (systolic pressure higher than 160mmHg)
• Current use of systemic medications known to be toxic to the retina
• History of thromboembolic events (incl MI and stroke) within 5 years
• Major surgery within previous 3 months or planned within the next 28 days
• Known coagulation abnormalities or current use of anticoagulative medications other than aspirins
• Known hypersensitivity to ranibizumab or any component of it
• Women of childbearing potential unless 2 methods of birth control applied
• Pregnant or lactating women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Semmelweis University

OTHER

Sponsor Role: collaborator

Attila Vajas

OTHER

Sponsor Role: lead

Responsible Party

Attila Vajas

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Attila Vajas, MD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Pharmacy

Locations

University of Debrecen, Medical and Health Science Center, Faculty of Medicine, Department of Ophthalmology

Debrecen, , Hungary

Countries

Hungary

References

Dervenis P, Dervenis N, Smith JM, Steel DH. Anti-vascular endothelial growth factors in combination with vitrectomy for complications of proliferative diabetic retinopathy. Cochrane Database Syst Rev. 2023 May 31;5(5):CD008214. doi: 10.1002/14651858.CD008214.pub4.

Reference Type: DERIVED

PMID: 37260074 (View on PubMed)

Other Identifiers

CRFB002AHU03T

Identifier Type: -

Identifier Source: org_study_id