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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
History of Changes
  Purpose

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 Intervention Phase
Macular Edema
Diabetic Retinopathy
 Drug: triamcinolone and bevacizumab
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravitreal Combination Therapy Using Triamcinolone and Bevacizumab Improves Vision in Patients With Diabetic Retinopathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Best Corrected Visual Acuity [ Time Frame: Day of exam ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: April 2006
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00806169

Locations
Germany
Department of Vitreoretinal Surgery
Frankfurt / Main, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
  More Information

No publications provided

Responsible Party: Michael Koss, PI, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT00806169     History of Changes
Other Study ID Numbers: MK-KTDRP-2008
Study First Received: December 4, 2008
Last Updated: September 26, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johann Wolfgang Goethe University Hospitals:
combined therapy
DRP
efficacy
 safety
sustainability
macular edema due to DRP

Additional relevant MeSH terms:
Diabetic Retinopathy
Edema
Macular Edema
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Triamcinolone hexacetonide
 Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Bevacizumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013