Triamcinolone as Adjunctive Treatment to Laser Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
Information source: University of Sao Paulo
Information obtained from ClinicalTrials.gov on June 20, 2008
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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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
Ending date: July 2006
Last updated: March 2, 2007
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