Clinical trial NCT00443521: Triamcinolone as Adjunctive Treatment to Laser Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
Official title: Triamcinolone as Adjunctive Treatment to Laser Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetic Retinopathy
Keywords: Diabetes Mellitus/ complications
Diabetic Retinopathy
Triamcinolone
Laser coagulation
Tomography, optical coherence
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2007-03-06
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Visual acuity (ETDRS)
measure: Optic coherence tomography
measure: Vitreous haemorrhage
Secondary outcomes:
measure: Safety and Tolerance of the treatment
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Retina and Vitreous Service, Department of Ophthalmology. Hospital das Clínicas. University of São Paulo School of Medicine
Study officials:
affiliation: Retina and Vitreous Service, Department of Ophthalmology. Hospital das Clínicas. University of São Paulo School of Medicine, Brazil
name: Otacílio O Maia Júnior, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Retina and Vitreous Service, Department of Ophthalmology. Hospital das Clínicas. University of São Paulo School of Medicine, Brazil
name: Walter Y Takahashi, M.D.
role: STUDY_DIRECTOR
References: