Intravitreal Triamcinolone Acetonide for Diabetic Macular Edema
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ClinicalTrials.gov Identifier: NCT00476918 |
Recruitment Status : Unknown
Verified May 2007 by Heidelberg University.
Recruitment status was: Recruiting
First Posted : May 22, 2007
Last Update Posted : May 22, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Retinopathy Diabetic Macular Edema | Drug: Intravitreal injection (triamcinolone acetonide) | Phase 1 |
Patients with diabetic retinopathy suffer from visual acuity loss caused by diabetic macular edema. Intravitreal injected Triamcinolone Acetonide (steroid) reduces macular edema and increases visual acuity. The duration of its effect is however limited. Therefore, several injections are necessary.
In this study a dosage dependency of triamcinolone acetonide (high dosage vs low dosage) is performed. The primary outcome parameters are the number of treatments and the efficacy of each injection.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Dosage Dependency of Intravitreal Triamcinolone Acetonide for Treatment of Diabetic Macular Edema |
Study Start Date : | July 2006 |
Estimated Study Completion Date : | December 2007 |

- Visual acuity, no of treatments, duration of efficacy [ Time Frame: 12 months ]
- intraocular pressure, retinal thickness [ Time Frame: 12 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- diabetic macular edema and visual acuity between 20/200 and 20/40 age over 18 years
Exclusion Criteria:
- recent treatment with laser photocoagulation or intravitreal drugs

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00476918
Contact: Ulrich HM Spandau, PhD MD | +496213832242 | ulrich.spandau@augen.ma.uni-heidelberg.de | |
Contact: Anne Wickenhaeuser, MD | +496213832242 | anne.wickenhäuser@augen.ma.uni-heidelberg.de |
Germany | |
Dep of Ophthalmology, University of Mannheim | Recruiting |
Mannheim, Germany, 68167 | |
Principal Investigator: Ulrich HM Spandau, PhD MD |
Study Director: | Jost Jonas, PhD MD | Dep of Ophthalmology, University of Mannheim |
ClinicalTrials.gov Identifier: | NCT00476918 |
Other Study ID Numbers: |
21091968 Insurance no.: 20-770-968594 |
First Posted: | May 22, 2007 Key Record Dates |
Last Update Posted: | May 22, 2007 |
Last Verified: | May 2007 |
diabetic macular edema triamcinolone acetonide intravitreal steroid |
Macular Edema Diabetic Retinopathy Edema Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases |
Triamcinolone Triamcinolone Acetonide Triamcinolone hexacetonide Triamcinolone diacetate Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |