Retina Associates - Research Coordinators
 
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Study Detail: Alcon Elevated IOP

Trial Description Summary : Anecortave Acetate Depot (study drug) versus sham given only one time to patients with a specific Intra-Ocular Pressure (IOP) after any kind of steroid therapy for any condition (such as dermatitis, crohn’s disease, lybrinthitis, asthma etc.) administered by any route (except fluocinolone acetonide ocular implants).

 

Basic Trial Information

Phase

Disease

Status

Age

Sponsor

Protocol #

2

Elevated IOP

Enrolling

18 or older

Alcon

C-05-03

Study Duration: Six months

Eligibility Criteria:

Inclusion Criteria

· To include patients with a qualifying IOP increase as a result of steroid therapy administered by any route (excluding fluocinolone acetonide ocular implants), intravitreal or periocular injection,topical ocular, other topical administration, inhaled or chronic systemic.

· Patients with an IOP of at least 24 mmHg.

· Patients with an IOP increase ≥ 10 mmHg relative to their pre-intravitreal steroid therapy IOP.

· If patients are on hypotensive medications, they must have at least 30 days of stable dosing prior to screening.

· Other inclusion criteria per the study coordinator.

 

Exclusion Criteria

· History of ocular trauma within the past 6 months in the study eye.

· Patients with a history of penetrating glaucoma surgery (i.e. trabeculectomy,valves,etc.) in the study eye.

· Patient has had an insertion of a scleral buckle in the study eye.

· Patients with a cup/disc ratio greater than 0.80 (horizontal or vertical measurement) in either eye

· Any abnormality preventing reliable applanation tonometry of the study eye.

· Clinical evidence of scleral thinning.

· Contact lens wearers who are not willing to discontinue use during the course of the study.

· Other exclusion criteria per the study coordinator.

 

General Medical Exclusion Criteria

· Patients who are on intravenous or subcutaneous anticoagulant therapy, or on oral anticoagulant therapy, (with the exception of aspirin and antiplatelet therapy) and cannot take a 5 day interruption in therapy prior to the injection procedure.

· Patients with a known medical history of allergy to the steroid family of drugs.

· Patients with a known medical history of allergy to the steroid family of drugs.

· Other exclusion criteria per the study coordinator.

Study Title : A Study of the Safety and Efficacy of Anecortave Acetate for Treatment of Steriod Induced IOP Elevation

Trial Contact Information

Site

Study Coordinator

Beachwood

Vivian at 216/831-5704 ext. 6800

Lakewood

Susan at 216/831-5704 ext. 6800