Alprostadil in Maculopathy Study (AIMS)

UCB

Status and phase

Terminated

Phase 3

Conditions

Macular Degeneration

Treatments

Drug: Alprostadil (prostaglandin E1)

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00619229

SP0878

2005-005686-11 (EudraCT Number)

Details and patient eligibility

About

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

Full description

Results of the planned interim analysis indicated that the number of originally planned patients were not sufficient to reach statistical significance in the primary end point. Instead of increasing the sample size accordingly, it was decided to terminate the study and plan future proceedings based on a careful analysis of the unblinded results.

Enrollment

37 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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