PST/Laser v. Laser Alone for CSME

• Status: Unknown status
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Edward Hines Jr. VA Hospital
• Treatments: Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

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.