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Ranibizumab vs Dexamethasone Implant in Vitrectomized Eyes With Diabetic Macular Edema

2019-09-19 03:56:42 | BioPortfolio

Summary

Vitrectomy is required for removal of vitreous hemorrhage or retinal traction tissue in some patients with proliferative diabetic retinopathy. Post-vitrectomy macular edema may occur in these diabetic patients. Intravitreal injections of anti-VEGF agents or corticosteroid are required for treating diabetic macular edema (DME) in vitrectomized eyes. Intraocular levels of various cytokines may alter in the diabetic eyes following vitrectomy. Pharmacokinetics may be different between various intraocular agents in vitrectomized eyes. Herein our study will prospectively randomize to compare the clinical behavior between intravitreal ranibizumab (IVR) and intravitreal dexamethasone implant (IDI) in vitrectomized patients with DME. To our knowledge, it is the first study involving such subject.

Description

Vitrectomy is required for removal of vitreous hemorrhage or retinal traction tissue in some patients with proliferative diabetic retinopathy. Post-vitrectomy macular edema may occur in these diabetic patients. Intravitreal injections of anti-VEGF agents or corticosteroid are required for treating diabetic macular edema (DME) in vitrectomized eyes. Intraocular levels of various cytokines may alter in the diabetic eyes following vitrectomy. Pharmacokinetics may be different between various intraocular agents in vitrectomized eyes. Herein our study will prospectively randomize to compare the clinical behavior between intravitreal ranibizumab (IVR) and intravitreal dexamethasone implant (IDI) in vitrectomized patients with DME. To our knowledge, it is the first study involving such subject.

Pseudophakic vitrectomized eyes with treatment-naïve center-involved DME will be enrolled with one eye in each patient. They are randomized into one group receiving IDI every 3 to 4 months, and the other group undergoing IVR using 3 monthly plus treat-and-extend injections all with monthly follow-up for 6 months. Switch of intravitreal drugs or deferred macular laser is not allowed. Primary outcome measures include change in central foveal thickness (CFT) in 1 mm by spectral-domain optic coherence tomography, and best corrected visual acuity (BCVA) at Month 6. Primary outcome measures include change in CFT and BCVA at Month 6. Injection number, BCVA, CFT, post-injection complications, and IOP are recorded and compared with Wilcoxon signed rank test within the group and Wilcoxon rank sum test between groups. Fisher's exact test is used for categorical comparison between groups. P value less than 0.05 is considered significant.

Study Design

Conditions

Diabetic Macular Edema

Intervention

dexamethasone implant, Ranibizumab

Location

Far Eastern Memorial Hospital
New Taipei
Taiwan
105

Status

Completed

Source

Far Eastern Memorial Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-19T03:56:42-0400

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Medical and Biotech [MESH] Definitions

Fluid accumulation in the outer layer of the MACULA LUTEA that results from intraocular or systemic insults. It may develop in a diffuse pattern where the macula appears thickened or it may acquire the characteristic petaloid appearance referred to as cystoid macular edema. Although macular edema may be associated with various underlying conditions, it is most commonly seen following intraocular surgery, venous occlusive disease, DIABETIC RETINOPATHY, and posterior segment inflammatory disease. (From Survey of Ophthalmology 2004; 49(5) 470-90)

Specialized ophthalmic technique used in the surgical repair and or treatment of disorders that include retinal tears or detachment; MACULAR HOLES; hereditary retinal disease; AIDS-related retinal infections; ocular tumors; MACULAR DEGENERATION; DIABETIC RETINOPATHY; and UVEITIS.

A recombinant humanized monoclonal antibody fragment that binds VEGF-A to prevent its binding to VEGFR-1 and VEGFR-2 receptors. This activity reduces vessel permeability and angiogenesis in the treatment of neovascular age-related MACULAR DEGENERATION.

A form of MACULAR DEGENERATION also known as dry macular degeneration marked by occurrence of a well-defined progressive lesion or atrophy in the central part of the RETINA called the MACULA LUTEA. It is distinguishable from WET MACULAR DEGENERATION in that the latter involves neovascular exudates.

Disease of the RETINA as a complication of DIABETES MELLITUS. It is characterized by the progressive microvascular complications, such as ANEURYSM, interretinal EDEMA, and intraocular PATHOLOGIC NEOVASCULARIZATION.

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