- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00806169
Combined Triple Therapy in Diabetic Retinopathy (DRP)
September 26, 2012 updated by: Michael Koss, Johann Wolfgang Goethe University Hospital
Intravitreal Combination Therapy Using Triamcinolone and Bevacizumab Improves Vision in Patients With Diabetic Retinopathy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Hessen
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Frankfurt / Main, Hessen, Germany, 60590
- Department of Vitreoretinal Surgery
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
group I (n=17) nonproliferative DR and ischemic maculopathy
|
|
Experimental: 2
group II (n=38) nonproliferative DR without ischemic maculopathy
|
|
Experimental: 3
group III (n=18) proliferative DR with or without ischemic maculopathy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Best Corrected Visual Acuity
Time Frame: Day of exam
|
Day of exam
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
December 4, 2008
First Submitted That Met QC Criteria
December 9, 2008
First Posted (Estimate)
December 10, 2008
Study Record Updates
Last Update Posted (Estimate)
September 27, 2012
Last Update Submitted That Met QC Criteria
September 26, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Diabetes Complications
- Diabetes Mellitus
- Retinal Degeneration
- Macular Degeneration
- Retinal Diseases
- Diabetic Retinopathy
- Macular Edema
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
- Triamcinolone
Other Study ID Numbers
- MK-KTDRP-2008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Retina Macula InstituteAllerganCompletedDiabetic Macular Edema | Proliferative Diabetic Retinopathy | Non-proliferative Diabetic RetinopathyUnited States
Clinical Trials on triamcinolone and bevacizumab
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Rubens Belfort Jr.CompletedDiabetic Macular EdemaBrazil
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Shahid Beheshti University of Medical SciencesUnknownNeovascular Age-Related Macular DegenerationIran, Islamic Republic of
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Shahid Beheshti University of Medical SciencesUnknownDiabetic Macular EdemaIran, Islamic Republic of
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Asociación para Evitar la Ceguera en MéxicoUnknown
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Hospital Clinic of BarcelonaTerminated
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Yonsei UniversityWithdrawnMacular DegenerationKorea, Republic of
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Yeungnam University College of MedicineCompletedBranch Retinal Vein OcclusionKorea, Republic of
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Universidade Federal de GoiasCompleted
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University of Sao PauloCompletedDiabetic Macular Edema
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Shahid Beheshti University of Medical SciencesUnknownNeovascular Age-Related Macular DegenerationIran, Islamic Republic of