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Combined Triple Therapy in Diabetic Retinopathy (DRP)

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ClinicalTrials.gov Identifier: NCT00806169
Recruitment Status : Completed
First Posted : December 10, 2008
Last Update Posted : September 27, 2012
Information provided by (Responsible Party):
Michael Koss, Johann Wolfgang Goethe University Hospitals

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.

Condition or disease Intervention/treatment Phase
Macular Edema Diabetic Retinopathy Drug: triamcinolone and bevacizumab Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravitreal Combination Therapy Using Triamcinolone and Bevacizumab Improves Vision in Patients With Diabetic Retinopathy
Study Start Date : April 2006
Primary Completion Date : October 2008
Study Completion Date : November 2008

Arm Intervention/treatment
Experimental: 1
group I (n=17) nonproliferative DR and ischemic maculopathy
Drug: triamcinolone and bevacizumab
Experimental: 2
group II (n=38) nonproliferative DR without ischemic maculopathy
Drug: triamcinolone and bevacizumab
Experimental: 3
group III (n=18) proliferative DR with or without ischemic maculopathy
Drug: triamcinolone and bevacizumab

Primary Outcome Measures :
  1. Best Corrected Visual Acuity [ Time Frame: Day of exam ]

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00806169

Department of Vitreoretinal Surgery
Frankfurt / Main, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital

Responsible Party: Michael Koss, PI, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT00806169     History of Changes
Other Study ID Numbers: MK-KTDRP-2008
First Posted: December 10, 2008    Key Record Dates
Last Update Posted: September 27, 2012
Last Verified: September 2012

Keywords provided by Michael Koss, Johann Wolfgang Goethe University Hospitals:
combined therapy
macular edema due to DRP

Additional relevant MeSH terms:
Macular Edema
Retinal Diseases
Diabetic Retinopathy
Macular Degeneration
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone diacetate
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors