Diabetic Retinopathy, Macular Edema
Conditions
Keywords
combined therapy, DRP, efficacy, safety, sustainability, macular edema due to DRP
Brief summary
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
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.
Interventions
Sponsors
Johann Wolfgang Goethe University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best Corrected Visual Acuity | Day of exam |
Countries
Germany
Outcome results
None listed