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

NCT00931125 | Unknown Phase 2 DMC

• 1 other identifier: CRFB002AHU03T
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy

Keywords

Severe proliferative diabetic retinopathy

Outcome Measures

Primary Outcomes (1)

• Efficacy of preoperative intravitreal ranibizumab

  Efficacy, measured by surgical time, number of intraoperative bleedings, intraoperative retinal breaks,required endodiathermy

  OP day

Secondary Outcomes (4)

• Change in BCVA.

  6 months

• Effect in anatomical changes.

  3 ±1 days after injection

• Safety.

  Over 6 months.

• Retinal circulation integrity.

  Month 1, 3, 6.

Study Arms (2)

vitrectomy with ranibizumab

ACTIVE COMPARATOR

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

Drug: ranibizumab and vitrectomy

vitrectomy without ranibizumab

PLACEBO COMPARATOR

Patients receiving sham treatment before vitrectomy as a comparator arm

Procedure: vitrectomy without preoperative ranibizumab

Interventions

ranibizumab and vitrectomy DRUG

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

Also known as: Lucentis intravitreal injection.

vitrectomy with ranibizumab

vitrectomy without preoperative ranibizumab PROCEDURE

sham intravitreal injection before vitrectomy surgery

vitrectomy without ranibizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Attila Vajas: lead
• Semmelweis University: collaborator

Study Sites (1)

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

Debrecen, H-4012, Hungary

Location

Related Publications (1)

• 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.

  PMID: 37260074 DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Ranibizumab; Vitrectomy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Attila Vajas, MD

  National Institute of Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 1, 2009
• First Posted: July 2, 2009
• Study Start: March 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

HU (1)