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Triamcinolone as Adjunctive Treatment to Laser Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

Information source: University of Sao Paulo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Retinopathy

Intervention: Triamcinolone Acetonide 4 mg intravitreal injection (Drug); Panretinal photocoagulation (Procedure)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: University of Sao Paulo

Official(s) and/or principal investigator(s):
Otacílio O Maia Júnior, M.D., Principal Investigator, Affiliation: Retina and Vitreous Service, Department of Ophthalmology. Hospital das Clínicas. University of São Paulo School of Medicine, Brazil
Walter Y Takahashi, M.D., Study Director, Affiliation: Retina and Vitreous Service, Department of Ophthalmology. Hospital das Clínicas. University of São Paulo School of Medicine, Brazil

Summary

The purpose of the study is to evaluate intravitreal injection of triamcinolone acetonide after laser panretinal photocoagulation in the treatment of proliferative diabetic retinopathy.

Clinical Details

Official title: Triamcinolone as Adjunctive Treatment to Laser Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Visual acuity (ETDRS)

Optic coherence tomography

Vitreous haemorrhage

Secondary outcome: Safety and Tolerance of the treatment

Detailed description: 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

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Type II Diabetes

- symmetric proliferative diabetic retinopathy without high risk characteristics

- Informed consent signed

Exclusion Criteria:

- previous treatment for diabetic retinopathy

- media opacities that may interfere with clinical, photographically or OCT

examinations

- inability to understands the implications of the protocol

- Glaucoma or ocular hypertension

- Any other pathology that could cause retinal alterations

- Patients with any other situation that may interfere in study completion based in

Investigator´s opinion

Locations and Contacts

Retina and Vitreous Service, Department of Ophthalmology. Hospital das Clínicas. University of São Paulo School of Medicine, São Paulo 05403-000, Brazil
Additional Information

Starting date: March 2005
Last updated: March 2, 2007

Page last updated: August 23, 2015

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