Combined Triple Therapy in Diabetic Retinopathy (DRP)

Phase 3

Completed

• Conditions: Macular Edema; Diabetic Retinopathy
• Interventions: Drug: triamcinolone and bevacizumab

• Registration Number: NCT00806169
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

Brief Summary

The aim of this pilot study was to investigate the effects of an intravitreal combination therapy using triamcinolone and bevacizumab in patients with macular edema due to diabetic retinopathy.

Detailed Description

This prospective, monocenter pilot case series was conducted between May 2006 and November 2008. Patients were included because of DME and signs of pre- and early proliferation because of diabetic retinopathy.73 eyes of 56 patients were included, all of which had signed an informed consent to perform a pharmacosurgical procedure consisting of a 23 gauge core Pars Plana Vitrectomy (sutureless single stitch sclerotomy, cutter with 300 cuts/minute) with removement of 1.5ml vitreous and substitution with 1ml BSS, 8mg triamcinolone, and 1.25 mg bevacizumab. At baseline and follow-up, the best corrected visual acuity (BCVA; 6 m Snellen), and intraocular pressure (IOP; Goldmann tonometry), and central macular thickness (optical coherence tomography) were determined. In addition, the need for further treatment and adverse events were monitored.

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2008-10
• Study Completion: 2008-11
• Study First Submitted: 2008-12-04
• Study First Submitted QC: 2008-12-09
• Study First Posted: 2008-12-10
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-26
• Last Update Posted: 2012-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Diagnosis of diabetic retinopathy

  • macular edema more than 200 micron
  • vitreous bleeding because of angiography documented NVEs NVDs, based on the definitions of ETDRS

Exclusion Criteria

• Prior intraocular injection within 4 months
• Core or complete vitrectomy
• History of glaucoma or ocular hypertension
• Presence of iris neovascularization
• Significant media opacity
• Monocularity and pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	triamcinolone and bevacizumab	group I (n=17) nonproliferative DR and ischemic maculopathy
2	triamcinolone and bevacizumab	group II (n=38) nonproliferative DR without ischemic maculopathy
3	triamcinolone and bevacizumab	group III (n=18) proliferative DR with or without ischemic maculopathy

Primary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity	Day of exam

Trial Locations

Locations (1)

Department of Vitreoretinal Surgery; 🇩🇪 Frankfurt / Main, Hessen, Germany