PST/Laser v. Laser Alone for CSME
Prospective randomized clinical trial comparing Laser Alone v. Laser and posterior sub-tenon injection of triamcinolone acetonide for primary and refractory clinically significant macular edema.
Clinically significant macular edema (CSME) is one of the leading causes of vision loss in diabetic retinopathy. The current standard of care for CSME is focal/grid laser photocoagulation. However, many patients experience further vision loss and/or require multiple laser treatments. In recent studies, intraocular (intravitreal) injection of triamcinolone acetonide has been shown to be beneficial for CSME, however, risks of this procedure include endophthalmitis and increased risk of steroid-induced intraocular pressure (IOP) elevation. Posterior sub-Tenon injection (PST) of triamcinolone acetonide is commonly used for inflammatory conditions of the eye and recently, has been increasingly used for diabetic macular edema. The objective of this study is to determine whether combined treatment with PST triamcinolone acetonide and laser photocoagulation for CSME has decreased rates of moderate vision loss, increased visual gain, and decrease in central macular thickness compared to laser photocoagulation alone. Both primary (no previous history of focal/grid laser) and refractory (previous history of focal/grid laser) CMSE will be studied. Thirty (30) eyes with primary CSME and thirty (30) eyes with refractory CSME will be randomized into one of two groups: 1) PST/Laser group and 2) Laser alone group. All patients will have an Optical Coherence Tomography (OCT) at the initial and final visits. Patients assigned to PST/Laser group will use topical steroid (1% prednisolone acetate) four times a day for two weeks. Patients who have elevated IOP with topical steroids will not receive PST steroid injection. Following treatments, patients will be evaluated at 1 and 2 months for a dilated eye exam, visual acuity, and assessment of IOP. Moderate vision loss (loss of 15 ETDRS letters), vision gain (in ETDRS letters), and central macular thickness (measured by OCT) will be compared between groups. Multivariate analysis will also be used to compare outcomes from the two arms of the study.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Edward Hines Jr. VAH
Edward Hines Jr. VA Hospital
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00229918
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
An esterified form of TRIAMCINOLONE. It is an anti-inflammatory glucocorticoid used topically in the treatment of various skin disorders. Intralesional, intramuscular, and intra-articular injections are also administered under certain conditions.
A drug used to reduce hemorrhage in diabetic retinopathy.
Removal of the whole or part of the vitreous body in treating endophthalmitis, diabetic retinopathy, retinal detachment, intraocular foreign bodies, and some types of glaucoma.
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.
Vision considered to be inferior to normal vision as represented by accepted standards of acuity, field of vision, or motility. Low vision generally refers to visual disorders that are caused by diseases that cannot be corrected by refraction (e.g., MACULAR DEGENERATION; RETINITIS PIGMENTOSA; DIABETIC RETINOPATHY, etc.).
Efficacy duration of triamcinolone acetonide (steroid) for treatment of diabetic macular edema. Furthermore, dosage dependency of triamcinolone acetonide comparing a high dosage versus a l...
Phase I/II study with intravitreal triamcinolone acetonide microspheres(RETAAC)for treatment of diffuse diabetic macular edema unresponsive to laser photocoagulation. Study hypothesis is t...
The purpose of the study is to evaluate intravitreal injection of triamcinolone acetonide after laser panretinal photocoagulation in the treatment of proliferative diabetic retinopathy.
The retinal vasculature changes dramatically in patients with diabetic retinopathy especially between non-proliferative and proliferative disease. The retinal vasculature can be imaged and...
Diabetic macular edema is the most common cause of visual loss among patients with diabetic retinopathy. Pars plana vitrectomy has been reported to be effective for the treatment of diabet...
Determination of triamcinolone acetonide in silicone oil and aqueous humor of vitrectomized rabbits' eyes: Application for a pharmacokinetic study with intravitreal triamcinolone acetonide injections (Kenalog(®) 40).
A simple and accurate method including liquid-liquid extraction and protein precipitation procedures from silicone oil and aqueous humor samples followed by high-performance liquid chromatography (HPL...
Diabetic macular edema (DME) remains an important worldwide cause of visual loss. Corticosteroids have a role in the treatment of some patients with advanced or recurrent DME. The best studied steroid...
Abstract Background: Both intravitreal bevacizumab and triamcinolone have been shown to be effective in treating macular edema secondary to VEGF-mediated disease. The purpose of this study is to descr...
Diabetes mellitus (DM) is associated with serious complications including macro- and microvascular problems such as diabetic retinopathy. Coronary involvement in diabetic patients is believed to be a...
A production process is described that yields nanocapsules instead of nanoparticles. The process allows the encapsulation of lipophilic drugs such as triamcinolone acetonide with an O/W emulsion syste...