PST/Laser v. Laser Alone for CSME

Status unconfirmed · Phase 2

Conditions studied: Diabetic Retinopathy

In brief

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.

Key facts

Study ID

NCT00229918

Run by

Edward Hines Jr. VA Hospital

People needed

60

Starts

2005-09-01

Expected to finish

2006-09-01

Last updated by the study team

2005-09-30

Who can join

Age: 25 and older, up to 80. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Edward Hines Jr. VAH — Hines, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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