Combined Triple Therapy in Diabetic Retinopathy (DRP)

Study Overview
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Brief Summary
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The aim of this pilot study was to investigate the effects of an intravitreal combination therapy using triamcinolone and bevacizumab in patients with macular edema due to diabetic retinopathy.

Detailed Description
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This prospective, monocenter pilot case series was conducted between May 2006 and November 2008. Patients were included because of DME and signs of pre- and early proliferation because of diabetic retinopathy.73 eyes of 56 patients were included, all of which had signed an informed consent to perform a pharmacosurgical procedure consisting of a 23 gauge core Pars Plana Vitrectomy (sutureless single stitch sclerotomy, cutter with 300 cuts/minute) with removement of 1.5ml vitreous and substitution with 1ml BSS, 8mg triamcinolone, and 1.25 mg bevacizumab. At baseline and follow-up, the best corrected visual acuity (BCVA; 6 m Snellen), and intraocular pressure (IOP; Goldmann tonometry), and central macular thickness (optical coherence tomography) were determined. In addition, the need for further treatment and adverse events were monitored.

Official Title
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Intravitreal Combination Therapy Using Triamcinolone and Bevacizumab Improves Vision in Patients With Diabetic Retinopathy

Conditions
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Macular Edema, Diabetic Retinopathy

Intervention / Treatment
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* Drug: triamcinolone and bevacizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of diabetic retinopathy macular edema more than 200 micron vitreous bleeding because of angiography documented NVEs NVDs, based on the definitions of ETDRS Exclusion Criteria: Prior intraocular injection within 4 months Core or complete vitrectomy History of glaucoma or ocular hypertension Presence of iris neovascularization Significant media opacity Monocularity and pregnancy

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>group I (n=17) nonproliferative DR and ischemic maculopathy | Drug: triamcinolone and bevacizumab<br> <br> |
| Experimental: 2<br>group II (n=38) nonproliferative DR without ischemic maculopathy | Drug: triamcinolone and bevacizumab<br> <br> |
| Experimental: 3<br>group III (n=18) proliferative DR with or without ischemic maculopathy | Drug: triamcinolone and bevacizumab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual Acuity |  | Day of exam | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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combined therapy, DRP, efficacy, safety, sustainability, macular edema due to DRP