Alprostadil in Maculopathy Study (AIMS)

• Status: Terminated
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of efficacy of alprostadil (prostaglandin E1) for treatment of patients suffering from dry age-related macula degeneration

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: Alprostadil

Criteria

Inclusion Criteria:

• Male and female subjects older than 50 years of age.

• Dry age-related macula degeneration (AMD) with hard drusen and possibly beginning geographic atrophy in one eye

• Visual acuity between 0.2 and 0.7 (logMAR) assessed with ETDRS charts

Exclusion Criteria:

• Dry AMD AREDS category 3 or 4 in both eyes

• Wet AMD in at least one eye

• Detachment of the pigmentary epithelium

• Glaucoma

• Diabetic retinopathy

• Medical history of retinal vein occlusion

• Uveitis

• Cataract surgery during the study

• High myopia (< -6 dpt) with pathological findings of the retina

• Medical history of any opthalmic surgery with complications

• Medical history of cataract surgery without complications within the last 12 weeks

• Medical history of vitrectomy

• AREDS medication within the last 2 days

• Opthalmologic dietary supplements within the last 2 days

• 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 > 1,5 mg/dL)

• Subject has known existing malignant disease

• Severe chronic obstructive pulmonary disease

• Subject has a venoocclusive lung disease

• Known hepatic disease

• Inadequately controlled or untreated hypertension (systolic blood pressure ≥ 180 mmHg, diastolic blood pressure ≥ 110 mmHg)

• Subject has upper grade cardiac valvular disorders

• Pregnancy or lactation period

• Known hypersensitivity to PGE1 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

• Subject has other serious illness

• Laboratory values outside the normal range unless considered not clinically relevant by the investigator