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

Diabetic Retinopathy Clinical Trial

— VITARM  

Official title:

Randomized, Double Blinded, Controlled, Two-center Study Assessing the Safety and Efficacy of Intravitreal Ranibizumab as a Preoperative Adjunct Treatment Before Vitrectomy Surgery in Proliferative Diabetic Retinopathy (PDR) Compared to Vitrectomy Alone

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00931125
• Other study ID #: CRFB002AHU03T
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 1, 2009
• Last updated: October 14, 2013
• Start date: March 2009
• Est. completion date: December 2013

Study information

• Verified date: October 2013
• Source: University of Debrecen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• ranibizumab and vitrectomy
ranibizumab 10mg/ml intravitreal injection, 0,05 ml

Procedure:
• vitrectomy without preoperative ranibizumab
sham intravitreal injection before vitrectomy surgery

Locations

Country	Name	City	State
Hungary	University of Debrecen, Medical and Health Science Center, Faculty of Medicine, Department of Ophthalmology	Debrecen

Sponsors (2)

Lead Sponsor	Collaborator
Attila Vajas	Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of preoperative intravitreal ranibizumab	Efficacy, measured by surgical time, number of intraoperative bleedings, intraoperative retinal breaks,required endodiathermy	OP day	No
Secondary	Change in BCVA.		6 months	No
Secondary	Effect in anatomical changes.		3 ±1 days after injection	No
Secondary	Safety.		Over 6 months.	Yes
Secondary	Retinal circulation integrity.	Evaluating the circulation of original retinal vessels, evaluating the size of proliferative vessels (size of leaking areas and number of leaking points measured by Fluorescein angiography )	Month 1, 3, 6.	Yes