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

Tracking Information
First Received Date ^ICMJE	December 4, 2008
Last Updated Date	September 26, 2012
Start Date ^ICMJE	April 2006
Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 26, 2012)	Best Corrected Visual Acuity [ Time Frame: Day of exam ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00806169 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Combined Triple Therapy in Diabetic Retinopathy (DRP)
Official Title ^ICMJE	Intravitreal Combination Therapy Using Triamcinolone and Bevacizumab Improves Vision in Patients With Diabetic Retinopathy
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 Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Macular Edema Diabetic Retinopathy
Intervention ^ICMJE	Drug: triamcinolone and bevacizumab
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	40
Completion Date	November 2008
Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	21 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT00806169
Other Study ID Numbers ^ICMJE	MK-KTDRP-2008
Has Data Monitoring Committee	No
Responsible Party	Michael Koss, Johann Wolfgang Goethe University Hospitals
Study Sponsor ^ICMJE	Johann Wolfgang Goethe University Hospitals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Johann Wolfgang Goethe University Hospitals
Verification Date	September 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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