PST/Laser v. Laser Alone for CSME - Full Text View

Sponsor:	Edward Hines Jr. VA Hospital
Information provided by:	Edward Hines Jr. VA Hospital
ClinicalTrials.gov Identifier:	NCT00229918

Purpose

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.

Condition	Intervention	Phase
Diabetic Retinopathy	Drug: triamcinolone acetonide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Combined Posterior Sub-Tenon Injection of Triamcinolone Acetonide and Laser Photocoagulation for the Treatment of Clinically Significant Macular Edema

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Diabetic Eye Problems Edema Retinal Disorders

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

Further study details as provided by Edward Hines Jr. VA Hospital:

Primary Outcome Measures:

Vision loss
Vision gain
Central macular thickness

Secondary Outcome Measures:

Increased intraocular pressure

Estimated Enrollment:	60
Study Start Date:	September 2005
Estimated Study Completion Date:	September 2006

Detailed 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.

Eligibility

Ages Eligible for Study:	25 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

The criteria listed below must be satisfied in order for the patient to be eligible for the study.

Age 25 to 80, inclusive.
Primary CSME: CSME secondary to diabetic retinopathy as defined by the ETDRS in one or both eyes with no previous history of focal/grid laser photocoagulation.
Refractory CSME: CSME secondary to diabetic retinopathy as defined by the ETDRS in one or both eyes with at least one session of focal/grid laser photocoagulation. Additionally, the eye must have a central macular thickness of at least 300 μM (normal, 200 μM) as measured by OCT and vision loss from baseline.
- All patients in the Hines VA Eye Clinic with suspicion of CSME will be referred to the Hines VA Retina Clinic where they will be evaluated by a Retina specialist (Dr. De Alba) and where the diagnosis of CSME will be confirmed by clinical examination and fluorescein angiography.

Exclusion Criteria:

If any of the exclusion criteria listed below is/are present, the patient will not be eligible for the study.

Unwilling or unable to give consent.
Unable to return for scheduled follow-up visits.
No light perception, light perception, count fingers, or hand motion vision.
History of glaucoma (any form).
History of ocular hypertension.
History of IOP elevation with ocular and/or systemic steroid treatment.
Baseline IOP greater than 22 mmHg.
All patients with IOP elevation greater than 22 mmHg following treatment with topical prednisolone acetate.
All patients with IOP elevation greater than 5 mmHg from baseline measurement following treatment with topical Prednisolone acetate.
Advanced proliferative diabetic retinopathy.
History of retinal detachment in either eye.
Any ocular disease (anterior or posterior segment) obstructing the view of the fundus (i.e., dense cataract, vitreous hemorrhage).
History of PST or intravitreal triamcinolone acetonide injection in either eye six months prior to the study.
History of 20/200 vision or worse from any cause in the fellow eye.
Active inflammatory, infectious, or idiopathic keratitis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00229918

Contacts

Contact: Felipe de Alba, MD	(708) 202-2061 ext 22061	fdealba@lumc.edu
Contact: Anuradha Khanna, MD	(708) 202-2061 ext 22061	akhanna@med.va.gov

Locations

United States, Illinois
Edward Hines Jr. VAH	Recruiting
Hines, Illinois, United States, 60141
Contact: Anuradha Khanna, MD 708-202-2061 ext 22061 akhanna@med.va.gov
Principal Investigator: Felipe de Alba, MD
Principal Investigator: Anuradha Khanna, MD
Sub-Investigator: John Galasso, MD, PhD

Sponsors and Collaborators

Edward Hines Jr. VA Hospital

Investigators

Principal Investigator:	Felipe de Alba, MD	Edward Hines Jr. VAH
Principal Investigator:	Anuradha Khanna, MD	Edward Hines Jr. VAH

More Information

No publications provided

Study ID Numbers:	PST/CSME
Study First Received:	September 28, 2005
Last Updated:	September 28, 2005
ClinicalTrials.gov Identifier:	NCT00229918 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Edward Hines Jr. VA Hospital:

Diabetic macular edema
Clinically significant macular edema

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Triamcinolone hexacetonide
Diabetic Angiopathies
Macular Edema
Triamcinolone Acetonide
Therapeutic Uses
Triamcinolone
Cardiovascular Diseases
Diabetes Complications

Retinal Diseases
Eye Diseases
Diabetes Mellitus
Vascular Diseases
Retinal Degeneration
Macular Degeneration
Endocrine System Diseases
Enzyme Inhibitors
Triamcinolone diacetate
Glucocorticoids
Immunosuppressive Agents
Pharmacologic Actions
Diabetic Retinopathy

ClinicalTrials.gov processed this record on February 08, 2010