PST/Laser v. Laser Alone for CSME
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|ClinicalTrials.gov Identifier: NCT00229918|
Recruitment Status : Unknown
Verified September 2005 by Edward Hines Jr. VA Hospital.
Recruitment status was: Recruiting
First Posted : September 30, 2005
Last Update Posted : September 30, 2005
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|Condition or disease||Intervention/treatment||Phase|
|Diabetic Retinopathy||Drug: triamcinolone acetonide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Combined Posterior Sub-Tenon Injection of Triamcinolone Acetonide and Laser Photocoagulation for the Treatment of Clinically Significant Macular Edema|
|Study Start Date :||September 2005|
|Study Completion Date :||September 2006|
- Vision loss
- Vision gain
- Central macular thickness
- Increased intraocular pressure
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||25 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||Yes|
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.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00229918
|Contact: Felipe de Alba, MD||(708) 202-2061 ext firstname.lastname@example.org|
|Contact: Anuradha Khanna, MD||(708) 202-2061 ext email@example.com|
|United States, Illinois|
|Edward Hines Jr. VAH||Recruiting|
|Hines, Illinois, United States, 60141|
|Contact: Anuradha Khanna, MD 708-202-2061 ext 22061 firstname.lastname@example.org|
|Principal Investigator: Felipe de Alba, MD|
|Principal Investigator: Anuradha Khanna, MD|
|Sub-Investigator: John Galasso, MD, PhD|
|Principal Investigator:||Felipe de Alba, MD||Edward Hines Jr. VAH|
|Principal Investigator:||Anuradha Khanna, MD||Edward Hines Jr. VAH|
|Other Study ID Numbers:||
|First Posted:||September 30, 2005 Key Record Dates|
|Last Update Posted:||September 30, 2005|
|Last Verified:||September 2005|
Diabetic macular edema
Clinically significant macular edema
Endocrine System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action