PST/Laser v. Laser Alone for CSME

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Primary Purpose

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

triamcinolone acetonide

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Diabetic macular edema, Clinically significant macular edema

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Edward Hines Jr. VAHRecruiting

Outcomes

Primary Outcome Measures

Vision loss

Vision gain

Central macular thickness

Secondary Outcome Measures

Increased intraocular pressure

Full Information

NCT ID

NCT00229918

First Posted

September 28, 2005

Last Updated

September 28, 2005

Sponsor

Edward Hines Jr. VA Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00229918

Brief Title

PST/Laser v. Laser Alone for CSME

Official Title

Combined Posterior Sub-Tenon Injection of Triamcinolone Acetonide and Laser Photocoagulation for the Treatment of Clinically Significant Macular Edema

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Unknown status

Study Start Date

September 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Edward Hines Jr. VA Hospital

4. Oversight

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Retinopathy

Keywords

Diabetic macular edema, Clinically significant macular edema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Randomized

Enrollment

60 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

triamcinolone acetonide

Primary Outcome Measure Information:

Title

Vision loss

Title

Vision gain

Title

Central macular thickness

Secondary Outcome Measure Information:

Title

Increased intraocular pressure

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Felipe de Alba, MD

Phone

(708) 202-2061

Ext

22061

Email

fdealba@lumc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Anuradha Khanna, MD

Phone

(708) 202-2061

Ext

22061

Email

akhanna@med.va.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Felipe de Alba, MD

Organizational Affiliation

Edward Hines Jr. VAH

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Anuradha Khanna, MD

Organizational Affiliation

Edward Hines Jr. VAH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Edward Hines Jr. VAH

City

Hines

State/Province

Illinois

ZIP/Postal Code

60141

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anuradha Khanna, MD

Phone

708-202-2061

Ext

22061

Email

akhanna@med.va.gov

First Name & Middle Initial & Last Name & Degree

Felipe de Alba, MD

First Name & Middle Initial & Last Name & Degree

Anuradha Khanna, MD

First Name & Middle Initial & Last Name & Degree

John Galasso, MD, PhD

Diabetic Retinopathy

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial