Trial Information
Summary: Alprostadil in Macular Degeneration Study (AIMS)
Confirmatory, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel Groups Study to Assess the Efficacy and Safety of Prostaglandin E-1 in Subjects With Dry Age-Related Macular Degeneration.
Evaluation of efficacy of alprostadil for treatment of patients suffering from age-related macula degeneration
Inclusion Criteria:
- macular degeneration with hard drusen and with beginning geographic atrophy in one eye
- Male and female subjects older than 50 years of age.
Exclusion Criteria:
- Glaucoma
- Diabetic retinopathy
- Uveitis
- Medical history of any ophthalmic surgery with complications
- Medical history of cataract surgery without complications
- Medical history of vitrectomy
- AREDS medication
- Ophthalmologic dietary supplements
- Medical history of retinal hemorrhage
- Cardiac failure (NYHA grade II or higher)
- Inadequately controlled coronary heart disease or cardiac arrhythmia
- Subject has a medical history and/or suspicion of pulmonary edema or pulmonary infiltration
- Subject has a peripheral edema
- Myocardial infarction within 6 months prior to enrollment
- Subject has renal insufficiency, compensated retention (creatinine > 1.5mg/dL)
- Subject has known existing malignant disease
- Severe chronic obstructive pulmonary disease
- Subject has a veno-occlusive lung disease
- Known hepatic disease
- Inadequately controlled or untreated hypertension (systolic blood pressure = 180mmHg, diastolic blood pressure =110 mmHg
- Subject has upper grade cardiac valvular disorders
- Pregnancy or lactation period
- Known hypersensitivity to Prostaglandin E-1 (PGE-1) or to any component of the trial medication
- Subject has a history of chronic alcohol or drug abuse within the past 2 years
- Subject has known lactose intolerance
- Poor general state of health or other criteria
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Contact:
UCB Clinical Trial Call Center
Located in:
Muenster, Germany,
Telephone: +1-877-822-9493
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Trial listings updated: June 1, 2008 at 6:43:20 AM
