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

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00443521
Enrollment
30
Registered
2007-03-06
Start date
2005-03-31
Completion date
2006-07-31
Last updated
2007-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy

Keywords

Diabetes Mellitus/ complications, Diabetic Retinopathy, Triamcinolone, Laser coagulation, Tomography, optical coherence

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.

Interventions

DRUGTriamcinolone Acetonide 4 mg intravitreal injection

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
CollaboratorOTHER_GOV
University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Visual acuity (ETDRS)
Optic coherence tomography
Vitreous haemorrhage

Secondary

MeasureTime frame
Safety and Tolerance of the treatment

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026