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| Sponsor: | University of Sao Paulo |
|---|---|
| Collaborator: |
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. |
| Information provided by: | University of Sao Paulo |
| ClinicalTrials.gov Identifier: | NCT00443521 |
Purpose
The purpose of the study is to evaluate intravitreal injection of triamcinolone acetonide after laser panretinal photocoagulation in the treatment of proliferative diabetic retinopathy.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetic Retinopathy |
Drug: Triamcinolone Acetonide 4 mg intravitreal injection Procedure: Panretinal photocoagulation |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Triamcinolone as Adjunctive Treatment to Laser Panretinal Photocoagulation for Proliferative Diabetic Retinopathy |
| Estimated Enrollment: | 30 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | July 2006 |
The current gold standard for the treatment of proliferative diabetic retinopathy is panretinal photocoagulation. Therefore this study is designed using both treatments in the same patient: intravitreal triamcinolone plus panretinal photocoagulation in one eye, compared to panretinal photocoagulation alone in the contralateral eye. These patients had their visual acuity measured and complete ophthalmological examination was performed, including macular slit lamp examination, fluorescein angiography and optical coherence tomography.
Patients with symmetric proliferative diabetic retinopathy without high risk characteristics receive laser therapy in both eyes and triamcinolone injections in one eye. For the triamcinolone injections, numbing drops, antibiotic drops, and drops to dilate the pupil, and possibly and anesthetic injection, are put in the eye before the medicine is injected into the vitreous. Patients return for follow-up visits 1 day, 1 and 4 weeks after the injection, and then 3 and 6 months. Patients whose condition does not improve may undergo new evaluation.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Brazil | |
| Retina and Vitreous Service, Department of Ophthalmology. Hospital das Clínicas. University of São Paulo School of Medicine | |
| São Paulo, Brazil, 05403-000 | |
| Principal Investigator: | Otacílio O Maia Júnior, M.D. | Retina and Vitreous Service, Department of Ophthalmology. Hospital das Clínicas. University of São Paulo School of Medicine, Brazil |
| Study Director: | Walter Y Takahashi, M.D. | Retina and Vitreous Service, Department of Ophthalmology. Hospital das Clínicas. University of São Paulo School of Medicine, Brazil |
More Information
| ClinicalTrials.gov Identifier: | NCT00443521 History of Changes |
| Other Study ID Numbers: | 310/05 |
| Study First Received: | March 2, 2007 |
| Last Updated: | March 2, 2007 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
|
Diabetes Mellitus/ complications Diabetic Retinopathy Triamcinolone Laser coagulation Tomography, optical coherence |
|
Diabetic Retinopathy Retinal Diseases Eye Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Triamcinolone hexacetonide Triamcinolone Acetonide Triamcinolone |
Triamcinolone diacetate Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
