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

Study Overview
=================
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.

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

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Drug: Triamcinolone Acetonide 4 mg intravitreal injection
* Procedure: Panretinal photocoagulation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Triamcinolone Acetonide 4 mg intravitreal injection|nan|
|Procedure: Panretinal photocoagulation|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity (ETDRS) |  |  | 
| Optic coherence tomography |  |  | 
| Vitreous haemorrhage |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerance of the treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus/ complications, Diabetic Retinopathy, Triamcinolone, Laser coagulation, Tomography, optical coherence