Combined Triple Therapy in Diabetic Retinopathy (DRP)

Johann Wolfgang Goethe University Hospital

Status and phase: Completed; Phase 3

Conditions: Macular Edema; Diabetic Retinopathy

Treatments: Drug: triamcinolone and bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT00806169

MK-KTDRP-2008

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

1

Experimental group

Description:

group I (n=17) nonproliferative DR and ischemic maculopathy

Treatment:

Drug: triamcinolone and bevacizumab

2

Experimental group

Description:

group II (n=38) nonproliferative DR without ischemic maculopathy

Treatment:

Drug: triamcinolone and bevacizumab

3

Experimental group

Description:

group III (n=18) proliferative DR with or without ischemic maculopathy

Treatment:

Drug: triamcinolone and bevacizumab