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| Name | Class |
|---|---|
| Coordenação de Aperfeiçoamento de Pessoal de NÃvel Superior. | OTHER_GOV |
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The purpose of the study is to evaluate intravitreal injection of triamcinolone acetonide after laser panretinal photocoagulation in the treatment of proliferative diabetic retinopathy.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone Acetonide 4 mg intravitreal injection | Drug | |||
| Panretinal photocoagulation | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity (ETDRS) | ||
| Optic coherence tomography | ||
| Vitreous haemorrhage |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerance of the treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| OtacÃlio O Maia Júnior, M.D. | Retina and Vitreous Service, Department of Ophthalmology. Hospital das ClÃnicas. University of São Paulo School of Medicine, Brazil | Principal Investigator |
| Walter Y Takahashi, M.D. | Retina and Vitreous Service, Department of Ophthalmology. Hospital das ClÃnicas. University of São Paulo School of Medicine, Brazil | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina and Vitreous Service, Department of Ophthalmology. Hospital das ClÃnicas. University of São Paulo School of Medicine | São Paulo | São Paulo | 05403-000 | Brazil |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D048909 | Diabetes Complications |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| D058449 | Intravitreal Injections |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D056965 | Injections, Intraocular |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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