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NCT00806169 Clinical Trial

Combined Triple Therapy in Diabetic Retinopathy (DRP)

Diabetic Retinopathy Clinical Trial

Official title:
Intravitreal Combination Therapy Using Triamcinolone and Bevacizumab Improves Vision in Patients With Diabetic Retinopathy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00806169
Other study ID # MK-KTDRP-2008
Secondary ID
Status Completed
Phase Phase 3
First received December 4, 2008
Last updated September 26, 2012
Start date April 2006
Est. completion date November 2008

Study information
Verified date September 2012
Source Johann Wolfgang Goethe University Hospitals
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date November 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• triamcinolone and bevacizumab

Locations
Country Name City State
Germany Department of Vitreoretinal Surgery Frankfurt / Main Hessen

Sponsors (1)
Lead Sponsor Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Best Corrected Visual Acuity Day of exam No
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