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Combined Triple Therapy in Diabetic Retinopathy (DRP)

NCT ID: NCT00806169

Last Updated: 2012-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-11-30

Brief Summary

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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

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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.

Conditions

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Macular Edema Diabetic Retinopathy

Keywords

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combined therapy DRP efficacy safety sustainability macular edema due to DRP

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

group I (n=17) nonproliferative DR and ischemic maculopathy

Group Type EXPERIMENTAL

triamcinolone and bevacizumab

Intervention Type DRUG

2

group II (n=38) nonproliferative DR without ischemic maculopathy

Group Type EXPERIMENTAL

triamcinolone and bevacizumab

Intervention Type DRUG

3

group III (n=18) proliferative DR with or without ischemic maculopathy

Group Type EXPERIMENTAL

triamcinolone and bevacizumab

Intervention Type DRUG

Interventions

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triamcinolone and bevacizumab

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Michael Koss

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Vitreoretinal Surgery

Frankfurt am Main, Hesse, Germany

Site Status

Countries

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Germany

Other Identifiers

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MK-KTDRP-2008

Identifier Type: -

Identifier Source: org_study_id