- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00229918
PST/Laser v. Laser Alone for CSME
Combined Posterior Sub-Tenon Injection of Triamcinolone Acetonide and Laser Photocoagulation for the Treatment of Clinically Significant Macular Edema
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Felipe de Alba, MD
- Phone Number: 22061 (708) 202-2061
- Email: fdealba@lumc.edu
Study Contact Backup
- Name: Anuradha Khanna, MD
- Phone Number: 22061 (708) 202-2061
- Email: akhanna@med.va.gov
Study Locations
-
-
Illinois
-
Hines, Illinois, United States, 60141
- Recruiting
- Edward Hines Jr. VAH
-
Contact:
- Anuradha Khanna, MD
- Phone Number: 22061 708-202-2061
- Email: akhanna@med.va.gov
-
Principal Investigator:
- Felipe de Alba, MD
-
Principal Investigator:
- Anuradha Khanna, MD
-
Sub-Investigator:
- John Galasso, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Central macular thickness
|
Vision loss
|
Vision gain
|
Secondary Outcome Measures
Outcome Measure |
---|
Increased intraocular pressure
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Felipe de Alba, MD, Edward Hines Jr. VAH
- Principal Investigator: Anuradha Khanna, MD, Edward Hines Jr. VAH
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Diabetes Complications
- Diabetes Mellitus
- Retinal Degeneration
- Retinal Diseases
- Macular Degeneration
- Diabetic Retinopathy
- Macular Edema
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
Other Study ID Numbers
- PST/CSME
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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