Combined Triple Therapy in Diabetic Retinopathy (DRP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Koss, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00806169
First received: December 4, 2008
Last updated: September 26, 2012
Last verified: September 2012

December 4, 2008
September 26, 2012
April 2006
October 2008   (final data collection date for primary outcome measure)
Best Corrected Visual Acuity [ Time Frame: Day of exam ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00806169 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Combined Triple Therapy in Diabetic Retinopathy (DRP)
Intravitreal Combination Therapy Using Triamcinolone and Bevacizumab Improves Vision in Patients With Diabetic Retinopathy

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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Macular Edema
  • Diabetic Retinopathy
Drug: triamcinolone and bevacizumab
  • Experimental: 1
    group I (n=17) nonproliferative DR and ischemic maculopathy
    Intervention: Drug: triamcinolone and bevacizumab
  • Experimental: 2
    group II (n=38) nonproliferative DR without ischemic maculopathy
    Intervention: Drug: triamcinolone and bevacizumab
  • Experimental: 3
    group III (n=18) proliferative DR with or without ischemic maculopathy
    Intervention: Drug: triamcinolone and bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
November 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00806169
MK-KTDRP-2008
No
Michael Koss, Johann Wolfgang Goethe University Hospitals
Johann Wolfgang Goethe University Hospitals
Not Provided
Not Provided
Johann Wolfgang Goethe University Hospitals
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP