Status:
UNKNOWN
PST/Laser v. Laser Alone for CSME
Lead Sponsor:
Edward Hines Jr. VA Hospital
Conditions:
Diabetic Retinopathy
Eligibility:
MALE
25-80 years
Phase:
PHASE2
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, ma...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00229918
Start Date
September 1 2005
End Date
September 1 2006
Last Update
September 30 2005
Active Locations (1)
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1
Edward Hines Jr. VAH
Hines, Illinois, United States, 60141