PST/Laser v. Laser Alone for CSME

06:48 EDT 20th August 2014 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Conditions

Diabetic Retinopathy

Intervention

triamcinolone acetonide

Location

Edward Hines Jr. VAH
Hines
Illinois
United States
60141

Status

Recruiting

Source

Edward Hines Jr. VA Hospital

Results (where available)

View Results

Links

Clinical Trials [619 Associated Clinical Trials listed on BioPortfolio]

Intravitreal Triamcinolone Acetonide for Diabetic Macular Edema

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...

Intravitreal Triamcinolone Acetonide for Treatment of Refractory Diffuse Diabetic Macular Edema

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...

Triamcinolone as Adjunctive Treatment to Laser Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

The purpose of the study is to evaluate intravitreal injection of triamcinolone acetonide after laser panretinal photocoagulation in the treatment of proliferative diabetic retinopathy.

Vascular Remodeling and the Effects of Angiogenic Inhibition in 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...

Vitrectomy Without Internal Limiting Membrane Removal in the Treatment of Diffuse Diabetic Macular Edema: a Comparative Kenalog Vs Bevacizumab Intravitreal Injection Vs Control Study

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...

PubMed Articles [1985 Associated PubMed Articles listed on BioPortfolio]

The effect of posterior sub-Tenon's capsule triamcinolone acetonide injection to that of pars plana vitrectomy for diabetic macular edema.

To compare the effect of posterior sub-Tenon's capsule triamcinolone acetonide (STTA) injection to that of pars plana vitrectomy (PPV) for diabetic macular edema (DME).

Differential flow rate of commercially available triamcinolone with and without preservative through small-gauge needles.

To compare the flow rate through different gauge needles of triamcinolone acetonide with benzyl alcohol (TABA) versus preservative-free triamcinolone acetonide injectable suspension (TAIS).

Safety of intravitreal triamcinolone acetonide: an electrophysiologic and histopathological study in rabbits.

To evaluate the retinal safety of various doses of intravitreal triamcinolone acetonide (TA) in rabbits.

Effect of postaurical subcutaneously injection of triamcinolone acetonide for subjective tinnitus.

To determine whether postaurical subcutaneous injection of triamcinolone acetonide is effective for subjective tinnitus refractory to medical treatment.

Triamcinolone and bevacizumab as adjunctive therapies to panretinal photocoagulation for proliferative diabetic retinopathy.

Purpose. To evaluate efficacy of intravitreal triamcinolone (IVT) and bevacizumab (IVB) as adjunctive treatments to panretinal photocoagulation (PRP) in proliferative diabetic retinopathy (PDR). Metho...

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.).

More From BioPortfolio on "PST/Laser v. Laser Alone for CSME"

Search BioPortfolio:
Advertisement

Relevant Topic

Diabetes
Latest News Clinical Trials Research Drugs Reports Corporate
Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. The two main types of diabetes are: type 1 diabetes type 2 diabetes In the UK, diabetes affects approximately 2.9 million people. There are a...

Advertisement